Pee Safe, a hygiene and wellness brand owned by Redcliffe Hygiene, has partially closed their Series B round. The company has received $3 million out of their total round size of $6 million (approximately R 50 crore). The funding was led by Natco Pharma and Rainmatter Health, supported by Nithin Kamath and Nikhil Kamath, founders of Zerodha. Alkemi Growth Capital, an existing investor, also participated in the round.

Pee Safe has evolved into a comprehensive personal hygiene and fast-moving consumer goods (FMCG) brand and has diversified its product range to encompass various personal hygiene categories, addressing the needs of girls from puberty to menopause. This expansion includes the provision of intimate hygiene products such as reusable pads, tampons, menstrual cups, and more.

Vikas Bagaria, the Founder and CEO of Pee Safe, said, “This funding will accelerate our expansion efforts and establish us as the leading brand in the rapidly growing intimate wellness sector, which boasts a remarkable CAGR of 16 per cent. Over the past five years, Pee Safe has achieved a remarkable growth rate of 100 per cent CAGR, surpassing market expectations.”

Earlier this year, the company elevated Rithish Kumar, one of the early founding members as the Co-founder. Commenting on the transaction he added, “The newly acquired funds will be utilised to expand our retail presence in India, expand overseas with an omni-channel approach and allocate additional resources to marketing and awareness initiatives. Currently, we are available in over 15,000 physical retail stores across 70+ cities in India and maintain a strong online presence on major e-commerce platforms, in addition to our own online platforms. We also export to 20 countries in 5 continents.”

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How is the industry’s approach to drug development transforming? What are the imperatives that led to this change? How is Waters aiding advancements in drug development?

A central aim in drug development is to create new molecular entities into commercially viable drugs useful in managing diseases. While there are significant obstacles to marketing new drugs, the past 15 years have shown an increase in the number of drug approvals. The Food and Drug Administration (FDA) approved an average of 43 drugs in 2014-18, compared to an average of 23 in the first decade of the century. 

There is no doubt that cell and gene therapies present some of the most exciting opportunities for emerging drugs. The medical field is evolving fast and toward the direction of treating diseases previously incurable using genetic manipulations and genome editing. Super expensive solutions (up to $3 million per patient), albeit truly innovative in nature, make these treatments unavailable to most of the world’s population. 

Many millions of people are vaccinated against COVID-19, thanks to a messenger RNA (mRNA) encapsulated within a lipid nanoparticle. These novel drugs are impossible to develop, manufacture, and bring to market successfully without the use of analytical technologies, such as liquid chromatography (LC) and mass spectrometry (MS) instruments, chromatography columns and data capture, and analysis software offered by innovative companies, like Waters Corporation. For decades, Waters has been a trusted partner to many pharma and generics companies operating in India, particularly for small molecule QA/QC. 

As the demand for biologics and biosimilar drugs grows, an even greater degree of analytical data is sought, which is one reason for our recent acquisition of light-scattering leader, Wyatt Technology. When we pair Wyatt’s multi-angle and dynamic light scattering technologies with Waters’ LC instruments, size-exclusion chromatography columns, and data capture software, we can deliver to our customers a richer set of data for large molecule drug development and QA/QC. 

How is technology ushering in new paradigms in pharma R&D? How is Waters utilising technology to accelerate and enhance processes in the life sciences industry?

Drug company R&D is constantly pressured to improve productivity, provide support across geographies, and navigate complex regulatory environments. To manage these challenges, it becomes imperative for the pharmaceutical industry to keep pace with emerging technologies, and adopt efficient and agile operating models. Looming patent cliffs on blockbuster drugs, a constrained pricing environment, plus the prospect of pricing reform (especially in, but not limited to, the US) means many companies are prioritising R&D productivity improvement and pushing to get more out of every dollar invested in R&D. 

Waters, a global leader in analytical instruments and software for over 60 years, is focused on helping to solve problems that matter for customers in the life, materials, and food sciences. Leading pharma companies are already experiencing the benefits of our support in the reduction in errors, faster cycle times, enhanced innovation, higher productivity, and better compliance.

In October of 2021, Waters and Sartorius began a collaboration to help bioprocess scientists accelerate clone selection and process development with new tools for testing and measuring the product quality of recombinant drug products produced in a multi-parallel bioreactor.

This collaborative work facilitated the transfer of bioreactor sample data and analytical results between Sartorius Ambr multi-parallel bioreactor platforms and the Waters BioAccord LC-MS system. By co-locating these instruments in upstream bioprocessing labs, analytical turnaround times were significantly reduced as compared to the more traditional process of sending out samples to core analytical labs for the data needed for point-of-need decision-making. By empowering process development scientists to generate process quality attribute (PQA) data themselves, we enable them to make decisions about which molecules to advance into pre-clinical development more rapidly.

 With our joint announcement on June 4, 2023, Waters and Sartorius entered a new phase of our collaboration, this time to support downstream bioprocessing as well. By combining the Waters PATROL UPLC Process Analysis System as an at-line process analytical technology (PAT) tool with the intensified bioprocessing operations of the Sartorius Resolute BioSMB multi-column chromatography platform, we can help optimise continuous downstream operations to reduce production costs (e.g., resin consumption), and effectively monitor and manage product quality.

Waters and Sartorius are committed to supporting biologics manufacturers with the best upstream and downstream process development and drug product quality analytical tools to ensure the efficient manufacturing of safe and effective drug products. Our collaboration will continue with those objectives in mind.

Waters recently acquired Wyatt, a provider of light scattering and field-flow fractionation technologies. How will it enhance Waters’ capabilities to serve the life sciences market in India? 

By expanding our analytical capabilities beyond what LC-MS can provide alone, Wyatt brings new expertise and stronger data to novel modality applications which will improve our ability to help our customers solve some of the technical challenges in the development of biotherapies.

We know leading Indian companies are already using Wyatt light scattering technology, and the Waters-Wyatt portfolio will bring strong opportunities and leverage the existing direct and distributor presence. 

The biotechnology market in India has grown 14 per cent in the last year to more than $80 billion along with the offering of a strong CDMO presence. This aligns well with Waters and the expansion to customers with Wyatt’s light-scattering technologies. 

Any more interesting M&A in the offing? 

Waters is always looking at both organic and inorganic growth opportunities that can help us better serve our customers. We are excited by the recent acquisition of Wyatt Technology and the opportunities it can add to our portfolio. 

That said, Waters is investing to increase its technical expertise, capabilities, and reach into high-growth adjacent markets in areas that include bioprocessing, clinical diagnostics and early disease screening, sustainable polymers, and batteries.

What are the growth opportunities opening up in the pharma sector, globally and in India? How poised are you to leverage them?

India is known as the ‘Pharmacy of the World’, as the generic medicine supplier for over 200 countries, both developed and emerging markets. A large presence of local players producing branded generics, along with lower price levels, has provided India with a unique opportunity. Almost 50 per cent of drugs produced are exported and the remaining 50 per cent is consumed domestically. Pharma has learned to respond by producing large-scale drugs quickly compared to other countries. By the end of 2022, Indian pharma turned from volume to value creator. 

Waters has been a trusted partner to the Indian pharma industry during this time, providing liquid chromatography and mass spectrometry (LC-MS) technologies, and expertise that is vital to ensure quality and pre-release drug safety. Our instruments are widely deployed in pharma laboratories and contract manufacturers for QA/QC of small-molecule generic and large-molecule drugs. 

The biosimilar market in India is estimated to grow at 22 per cent CAGR to become $12 billion by 2025. The industry is looking for the identification of the right biologics or biosimilars to treat the next generation of auto-immune disorders, cancer, diabetes, rheumatoid arthritis, etc. In the coming years, approximately 10 biologic blockbusters will be released from the patent, creating enormous opportunities for Indian manufacturers of biosimilars to make the product most cost-effective.

With our acquisition of Wyatt Technologies, Waters India is well-aligned to support the industry as newer drugs and biosimilars are brought to market. When we combine Waters’ world-class LC instruments with Wyatt’s innovative light scattering technologies, we are positioned with vital products that biopharma companies use for discovery, product development, manufacturing, and QA/QC. Waters has an incredible opportunity as a strategic partner to the pharma industry to help India become a world leader in biosimilars. 

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Novasep and Sartorius Stedim Biotech have signed an agreement regarding the proposed sale of Novasep’s chromatography equipment division.

This proposed transaction covers operations located on different Novasep sites employing approximately 100 people, the majority of whom work at the Pompey site in eastern France and some in the US, China and India.
Novasep’s chromatography equipment division comprises resin-based batch and intensified chromatography systems, and primarily focuses on high-pressure, multi-use applications for smaller molecules, such as oligonucleotides, peptides and insulin. Since 2018, Novasep and Sartorius have been collaborating in the joint development of an optimised system for a membrane-based, low-pressure chromatography that processes larger molecules more productively and that will be launched soon.

This announcement is aligned with Novasep’s Rise-2 strategy, which is focused on prioritising its core business. The proposed transaction is a major step for the development of the equipment business worldwide, based on the long-term expertise of Novasep’s employees and Sartorius’ strong position on this market segment. It is subject to works council consultation and the approval of all relevant regulatory bodies.

“This deal marks one of the first steps in our Rise-2 strategic programme to focus the group towards our core business”, said Dr Michel Spagnol, President and CEO, Novasep. “We are delighted to strengthen our relationship with the Sartorius team and believe it will be a great opportunity for the chromatography equipment business to fully deliver its potential and accelerate its growth under this new ownership.”

“I am pleased that we will intensify our successful collaboration with the Novasep team, soon to be under the Sartorius roof,” said Dr René Fáber, Head of Sartorius Bioprocess Solutions Division and Executive Board member. “The Novasep portfolio will perfectly complement our existing chromatography offering and allow us to provide customers with more options for their manufacturing processes. Efficient DSP has remained a challenge in our industry for years, and Sartorius is committed to helping accelerate and simplify this crucial step so that new drugs can be manufactured much more efficiently.”

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India has been designated the ‘Vice-Chair’ of Good Laboratory Practice (GLP) Working Group of the Organisation for Economic Co-operation and Development (OECD), recognising the contribution of the Indian GLP programme.

Good Laboratory Practice (GLP) is a quality system, which has been evolved by Organisation for Economic Co-operation and Development (OECD) to ensure that safety data generated on various chemicals like industrial chemicals, pharmaceuticals (Human and Veterinary), agrochemicals, cosmetic products, food/ feed additives, and medical devices, etc., can be relied upon by regulatory authorities.

The Department of Science and Technology (DST), Government of India, established the National GLP Compliance Monitoring Authority (NGCMA) with the approval of the Union Cabinet on April 24, 2002.

NGCMA is the National body which grants GLP certification to test facilities (TFs) conducting safety studies on new chemicals of the above-mentioned categories in accordance with OECD Principles of GLP and OECD Council norms.

On March 3, 2011, India became full adherent to the Mutual Acceptance of Data (MAD) in the OECD.

“The MAD status has given global recognition to India’s non-clinical safety data by tremendously augmenting its credibility and acceptability across the globe. This has not only boosted the confidence of Indian GLP TFs but also led to removal of technical barriers to trade. The dedicated training of the inspectors and continued capacity building of Indian TFs in emerging areas by the ground team of NGCMA has resulted in upgrading Indian TFs to meet international standards,” informs a release from DST.

The spectrum of activities of Indian GLP TFs involves eight types of chemicals/test items and nine areas of expertise. Prof Ashutosh Sharma, Chairman-GLP Authority & Secretary, DST commented, “India’s leadership in GLP brings a greater recognition of our certification of quality for global businesses. This is also a link in the chain to Atamnirbharta, which is to have structures and processes that are adhered to global standards.”

The OECD has acknowledged the contribution of the Indian GLP program and designated Dr Ekta Kapoor, Scientist E, NGCMA, DST, as the Vice-Chair of the OECD Working Group on GLP for 2021 and 2022.

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The National Immunogenicity & Biologics Evaluation Center (NIBEC) for assessing clinical immunogenicity of viral vaccines has started operations. Established jointly by Bharati Vidyapeeth University through its constituent unit Interactive Research School for Health Affairs (IRSHA) and BIRAC-DBT, Government of India through National Biopharma Mission, the facility was inaugurated virtually by Dr Renu Swarup, Secretary, DBT, Government of India in an e-inauguration ceremony presided by Dr Vishwajeet Kadam, Minister of State; Government of Maharashtra.

NIBEC, established in about 10,000 sq ft, has one BSL-3+, 4 BSL-2 and 10 BSL-1 laboratories for key immunogenicity evaluation tests like Plaque Reduction Neutralization Test (PRNT), Microneutralisation assay, IgM and IgG ELISA, developed, standardised and validated for dengue, chikungunya and SARS-CoV-2 viruses. Reportedly, the laboratory has already started associating closely with leading Indian vaccine manufacturing companies and national and international institutes engaged in vaccine developments.

Inaugurating the facility via video conference, Dr Renu Swarup, Secretary, DBT, said that she has very high expectations from NIBEC with regards to clinical immunogenicity testing of vaccine candidates especially with the COVID 19 vaccine pipeline in the country. She further elaborated that having domestic capabilities maintaining international standards in this space, will accelerate and fast track development of indigenous vaccines in the country.

Speaking on the subject, Dr Vishwajeet Kadam, Minister of State; Government of Maharashtra said that Government support for the creation of such a facility at IRSHA is heart-warming. He acknowledged and thanked the support of DBT and BIRAC.

(Source: PIB)

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Acasti Pharma said its krill oil-derived drug candidate, CaPre, was not more effective than placebo in reducing high levels of triglycerides in a late-stage study.

US-listed shares of Acasti were down 54 per cent at $1 before the bell.

The Canada-based drug developer said CaPre failed to show a statistically significant reduction in blood triglycerides compared to placebo after 12 weeks and 26 weeks of treatment.

Triglycerides are a type of fat found in blood that contributes to heart disease alongside cholesterol.

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Dozens of drugmakers are conducting human trials for a record 89 therapies that pair antibodies with toxic agents to fight cancer, evidence of renewed confidence in an approach that has long fallen short of its promise, an analysis compiled for Reuters shows.

These antibody-drug conjugates, or ADCs, from companies including AztraZeneca and GlaxoSmithKline, are described by researchers as “guided missiles” packing a powerful anti-cancer punch.

They are engineered to zero in on tumours and then release cytotoxins that deliver up to 10,000 times the potency of standard chemotherapy, while minimizing damage to healthy tissue.

The approach has for decades been a major biotech industry focus. Many experimental ADCs, however, failed due to the complexity of pairing the right antibody with the appropriate toxic agent. Some were abandoned as too weak; others were too harmful.

From 2000 to 2018, only five ADCs won approval. Just one, Roche’s Kadcyla, approved in 2013 for breast cancer, has surpassed $1 billion in annual sales after data last year showed it boosted disease-free survival for some patients compared with the standard treatment, Roche’s Herceptin.

Over time, however, scientists devised better ways to connect payloads and antibodies and more precisely reach tumours. There is a growing understanding, too, of how to design ADCs to kill even surrounding cancer cells that previously evaded destruction.

“What we’re seeing now are the benefits of the science becoming mature,” said ADC pioneer Chris Martin, CEO of Switzerland’s ADC Therapeutics. “It took at least a decade, probably more like 15 years, to really begin to turn the art into a science.”

In 2019, U.S. regulators approved three ADCs, the most ever in a single year, as last-ditch treatments based on studies showing they helped patients whose survival outlook was bleak.

They include AstraZeneca’s and Daiichi Sankyo’s breast cancer drug, Enhertu, which was shown to help patients who had failed numerous previous treatments survive a median of more than 16 months before their disease worsened.

Astellas’ and Seattle Genetics’ bladder cancer drug, Padcev, also received expedited approval in December, based on evidence that 44% of patients who had failed immunotherapy showed improvement, and in some cases, no evidence of cancer, when they were assessed after treatment.

Roche’s Polivy was green-lighted against lymphoma in June after producing complete response rates, with no signs of disease, in 40% of patients when combined with two other therapies.

New Record

While all three drugs must prove their mettle in further studies, the industry is growing optimistic that ADCs’ time may have arrived.

The number of ADC drug candidates is at unprecedented levels, according to data from consultancy Beacon Targeted Therapies compiled for Reuters, based on a review of companies’ pipelines. Dozens more ADC prospects are in pre-clinical review.

London-based Beacon advises drugmakers on targeted therapies, helping them decide whether to pursue prospective drugs or redirect efforts, based on industry trends.

Current ADC projects include GlaxoSmithKline testing its belantamab mafodotin against multiple myeloma.

ADC Therapeutics, part-owned by private equity firm Auven Therapeutics, has several studies on experimental drugs, including with Danish partner Genmab, on blood cancers and solid tumours.

U.S. biotech Immunomedics’ market capitalization gained more than 60% to $4.3 billion in the last six months, ahead of the U.S. Food and Drug Administration’s late-December decision to review its ADC against triple-negative breast cancer, which is hard to treat and has poor prognosis.

Massachusetts-based ImmunoGen, hit by past trial failures, got a lift in December for its ADC against ovarian cancer when the FDA indicated it may become a candidate for accelerated approval.

The surge in ADC investment has been fueled, in part, by improvements in the so-called “linker” technology that binds the antibody to its cancer-killing toxins, keeping them stable in the circulatory system until the poison can be unleashed on the targeted tumour.

ADCs are generally delivered via repeated infusions, similar to chemotherapy.

“There is a revival again because there is a new generation of molecules in which the linker is more efficient,” Giuseppe Curigliano, clinical director of early drug development at Milan’s European Institute of Oncology, told Reuters.

Betting On Growth

This optimism has contract manufacturers like Merck KGaA and Lonza ramping up facilities, in hopes drugmakers will farm out complex ADC production.

Merck expects the overall ADC market to grow by more than 20% in coming years, boosting its business, which includes manufacturing of monoclonal antibodies, linkers and cytotoxic agents.

Rival Lonza, which helps make Roche’s two ADCs and sees annual 9% growth for the so-called bioconjugates market, is investing millions of dollars in its Swiss site, where it produces ADCs for other drugmakers.

“What we see over time at Lonza is a good request for capacity,” said Iwan Bertholjotti, Lonza’s bioconjugate commercial development head. “That’s a good sign that the market is booming.”

Still, enthusiasm is not universal.

AbbVie in August abandoned its ADC candidate Rova-T after flunking a lung cancer trial and wrote off most of the $5.8 billion it paid for the drug’s developer, Stemcentrx, in 2016.

Roche, which helped pioneer ADCs with Kadcyla and Polivy, has also backed off. In 2013, the Basel-based company had about a dozen experimental ADCs. Today, only one remains, and it is being developed for Staph infections, not cancer.

“We have shifted our technology priorities,” Roche CEO Severin Schwan told Reuters. “Maybe others will be luckier, but we failed to master the complexity.”

AstraZeneca aims to do just that.

In March, the Cambridge, England-based drugmaker struck a $7 billion deal with Japan’s Daiichi Sankyo for rights to Enhertu, getting $1.35 billion up-front, and more if it challenges Roche drugs’ dominance in breast cancer.

Some industry analysts see Enhertu sales eventually reaching up to $7 billion annually.

“Our plan is to expand the number of studies in different tumour types,” said Gilles Gallant, head of oncology R&D at Daiichi Sankyo. “This agent has potential.”

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As our cover story (Driving diagnostics with automation, pages 6-9) points out, automation will drive the diagnostic lab segment to greater levels of efficiency and accuracy,  but for most diagnostics clinics, Thyrocare’s move remains a gamble they cannot afford to take. Indeed, not more than five per cent of labs in India are automated. However, the diagnostic labs segment is ripe for consolidation and as more smaller labs become part of the larger diagnostic labs chains, lab automation will pick up.

Lab automation is the buzz word in other industries as well though the triggers are different. In the pharmaceutical and biotechnology industries, regulators are becoming more stringent, demanding compliance and harmonisation with global regulations. Non-compliance with new benchmarks often results in import alerts or worse, import bans. To avoid both revenue as well as reputation loss, pharma and biotech companies are investing in the prescribed analytical equipment or engaging laboratory services to test their samples. Keeping pace with the increased demand, analytical sciences, instrumentation and related technologies have seen a plethora of rapid advances. An analysis by Frost & Sullivan, ‘Analysis of the Indian Laboratory Analytical Instruments Market’, predicts that revenues of more than $762.5 million in 2012 will reach $2,370.0 million in 2018.

Charting the latest moves in this segment, the life sciences vertical of the Indian Express Group [Express Pharma and Express Healthcare] presents a special supplement LABNEXT featuring the latest instrumentation, technologies, products and services in major areas of analytical sciences and laboratory services.

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One of the major challenges faced by the new Indian government is to provide affordable healthcare to all. Healthcare in India, as elsewhere in the world, is
facing unprecedented challenges, including the economic burdens associated with rising costs, chronic diseases, and caring for ageing populations. The need for efficient systems to deliver quality healthcare is much more intensified today and healthcare providers face the challenging mandate of doing more with less.

Medical diagnostics is at the centre of healthcare delivery and is facing its own challenges. With increasing demand for tests, focus on quality and accuracy by physicians as well as changing economic paradigm, laboratories are forced to think out-of-the-box to keep functioning.

An estimated 70 per cent of medical decisions are based on laboratory test results. However, diagnostic laboratories in India are limited by means and resources. The thought of investing in an automation system feels like a daunting task, let alone expanding a laboratory or replacing existing systems. But the need for quality and reproducibility as well as the increasing demand for tests with less turn-around-time have only fuelled the need for adoption and use of laboratory automation.

The key challenge for the diagnostic industry is to find innovative and cost-effective ways to improve testing efficiency and eliminate errors. Given the variation of power supply in India, equipment manufacturers must have a clear vision of how to best enhance a laboratory’s capability with their automated equipment. The question the industry is asking today is how do laboratories adopt automation and how do they positively impact patient care?

Market snapshot

According to a report published by RNCOS Industry Research Solutions in June 2012, the Indian diagnostic services market is estimated to have generated Rs 97.3 billion in revenue during 2011 and is expected to grow at a compound annual growth rate (CAGR) of around 26 per cent to Rs 235.8 billion by 2015.

The market in India is highly fragmented. It is not surprising given its healthcare delivery structure, but of the estimated one lakh laboratories in India many have just basic facilities and only three to four laboratories are state-of-the-art multidisciplinary core labs. The hierarchy has specialised laboratories on the top, followed by laboratories in hospitals and nursing homes, and finally by small testing centres. All specialised laboratories operate in the private sector. The government at the best has semi-automated laboratories.

Test volumes range from 50 to 100 samples per day for one laboratory located in a small town to several thousand samples per day for a major laboratory.

“Test samples processed per day in a laboratory attached to a tertiary care hospital ranges from 500-1000,” informs Dr Arathi Prakash, Consultant, Clinical Bio Chemistry & Quality Manager, BGS Global Hospitals. The quality of services provided by these laboratories also varies widely.

“The National Accreditation Board for Testing and Calibration Laboratories (NABL) was established to accredit the laboratories; however, the number of accredited laboratories remains low since accreditation, so far, is voluntary,” informs Dr Vandana Lal, Executive Director, Dr Lal Pathlabs.

Currently, only about 10 per cent of the market is organised and composed of laboratories with proper accreditation.

Scaling challenges

Today, diagnostic laboratories are facing many challenges in order to remain competitive but the most important consideration is error. “Mistakes occur primarily due to human error, but there are also chances of random error,” says Dr Arathi Prakash, Consultant, Clinical Bio Chemistry and Quality Manager, BGS Global Hospitals.

As a result, quality control has gained immense importance in a clinical laboratory. But maintaining a good team of quality managers is again a challenge.

“A strong requirement for quality managers who are properly trained and have proper standard operating procedures in place is challenging,” says Dr Suvarna Ravindranath, General Manager Karnataka, SRL Diagnostics.

In fact, it is necessary to train and retain competent staff, which is equally challenging. Precision and accuracy are the mark of a good laboratory. Medical laboratories, through their systems, have to generate results that can be replicated or reproduced in different diagnostic centres.

“The hallmark of a good medical laboratory is accurate analysis and reporting of diagnostic tests carried out by them thereby helping the medical fraternity to recommend proper dosages of medicines to cure the patient. A high degree of quality control in testing therefore instils trust and confidence in the patients. Challenges include, but are not restricted to trained and skilled manpower in proper analysis, and use of test equipment,” explains V Ramakrishnan, Marketing Manager, Remi Elekrotechnik.

Automation gains

Since automation for clinical laboratories came into existence equipment manufacturers have been promoting the benefits of stand-alone and total laboratory automation systems. The crux of their marketing lies in the fact that these equipment save time, reduce manual steps and above all, remove the human element from testing to lower the risk of errors. So it does, but is automation really beneficial?

“Automation makes the process very easy, makes the process and manpower requirement less. Even with less manpower more tasks can be accomplished more efficiently,” says Dr Ravindranath. “Even the turnaround time will scale up to significant improvements and the chances of error is minimised to a large extent,” she adds.

Talking about the benefits, Ramakrishnan says, “Lab automation ensures reduction of human errors in diagnosis and reporting of test results.
It ensures consistent and reproducible results of same samples across different centres. It enhances the patients’ and doctors’ confidence on the test reports generated by the diagnostic centres.”

“Automation provide laboratories the ability to establish sustainable processes,” says Dr Lal. Giving an example, she says that if a mid-level laboratory wants to increase productivity and deliver faster testing results they can consider installing a new automation system. While automation decreases turn-around time from five days to less than two days it also helps the lab slash material cost since the test uses less sample and hence the number of tubes collected from each patient gets cut in half. It also helps to decrease water use, and produces less waste. As a result, overall lab costs reduce by 30 per cent. Thus, it creates a sustainable process for the lab.

Although automation seems highly beneficial it also comes with considerable expense. “The cost of automation is huge. Be it a hospital or stand-alone laboratory, investments are considerable and so there should be much thought given to the type of automation to opt for,” says Dr Prakash.

“Test assays are constantly evolving. The flexibility and adaptability of an automation system needs a lot of consideration. The system should have the ability to meet current testing needs and also be easily reconfigured to handle future demands,” she explains.

Automation and quality

Leveraging the full capability of automation to drive quality and productivity improvement is the aim of all laboratories. “Laboratory automation primarily is a means to improve efficiency and reduce human errors in all steps of testing. There is also an enhanced use of informatics continuum where there is a continuous recording of diagnostic test information. The electronic validation and authentication ensures better accuracy and consistent quality test results,” says Dr Th. Dhabali Singh, MD, BABINA Diagnostics, Imphal. Reiterating this view, Dr Lal says, “Automation leads to greater levels of quality. In our laboratory we use state-of-the-art laboratory automation with new-generation automation systems that tie together multiple analysers, pre-analytical and post-analytical automation devices, and software. “This helps us to process greater volumes of tests and improve turnaround times, while reducing errors, enhancing productivity, and lowering costs,” she adds.

While many believe that automation provides consistent quality, there are many who don’t buy this theory. “Lab automation alone will not ensure quality,” says Dr Ravindranath. “It will provide reproducibility only to a certain extent. There is a difference between quality and reproducibility. Reproducibility is something like precision but accuracy will come only if you practice quality. Quality procedures and standards need to be in place,” she further adds.

Routine quality control (QC) and maintenance of laboratory automation plays an important part in the upkeep and performance of instruments. “Quality management comprehensively includes controlling the quality of procedures at each and every step, including pre-analytical (specimen collection and transport), analytical (specimen processing in the lab) and post-analytical (reporting and interpretation of results). Concept of total quality management (TQM) is closely interlinked with good laboratory practices and goes far beyond the widely practiced conventional QC procedures. TQM includes technical accuracy and precision, equipment and supplies, staff training and skill, financial management (cost-effectiveness), lab safety, communication etc,” says Dr Prakash.

Prohibitive cost of automation

Manual labour is readily available and less expensive in India, however in a clinical laboratory automation supersedes manual labour. It requires a huge initial investment compared to the unit cost of the product. In India, automated laboratory equipment are expensive. Dr Singh informs, “The capital investment for automation is relatively huge. However, an advantage of automation is that it allows for a reduction in the manpower requirement and cost because of a leaner system.” He adds, “The best innovation that has come up is the development of customisable automation configurations that allow the flexibility of phased implementation.” “The cost of automation varies. If an analysis is needed to be interfaced with computers, this will not cost much. However if robotics is taken into consideration then alongwith automation it will definitely cost quite a lot,” says Dr Ravindranath.

So, it is understandable then that not many laboratories in India are fully automated. “Only five per cent of labs in India are automated,” reveals Dr Lal. “Most labs are semi-automated and some have a few automated equipment,” she adds. “It’s very difficult to analyse the labs in the public sector but as per my knowledge there are no fully automated clinical laboratories in the public sector,” she says.

Downtime in clinical laboratory automation is another hassle that needs to be addressed. Prompt service and annual maintenance is most desired in automated systems. Failure to maintain the automation system ultimately result in lost time and faulty results; both of which are detrimental to good patient care. “In India, it’s seen that a rental automated machine is better serviced and maintained than a purchased machine,” says Dr Prakash. “Manufacturers should ensure good maintenance and service despite the way in which the equipment is acquired,” she adds.

Looking to the future

Automation in clinical laboratory is gaining pace in India. In future, smaller laboratories will consolidate and feed samples to larger automated laboratories. “In the future, this market is expected to become more organised and consolidated as small and independent laboratories become franchisees in the hub-and-spoke model of the larger players. By 2015, 30 per cent of the market is predicted to be organised,” says Dr Lal. “This will lead to more automated labs in India,” she adds.

“Automation will extend beyond traditional robotics to include more mobile systems. Pre-analytical process will get more customised and efficient,” says Dr Ravindranath.

“Taking the human element out of the equation and utilising robotic automation only for clinical laboratory is the next step,” feels Dr Lal.

However, there are still some disciplines like histopathology and microbiology that are not fully automated. “In the future, automation will increase in the areas like the microbiology lab and the histopathological labs,” says Dr Prakash.

Clinical laboratory automation involves the integration or interfacing of automated or robotic transport systems, analytical instruments, and pre- or post-analytical process equipment such as automated centrifuges and aliquoters, decappers, recappers, sorters, and specimen storage and retrieval systems. In addition to the electrical and mechanical interfaces of these various components, the computers that control these devices or instruments must also be interfaced to each other and/ or the laboratory information system.

mneelam.kachhap@expressindia.com

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What are Newtronic’s plans’ for the future?

We are setting up our second manufacturing facility at Umbergaon. This facility will help us to achieve our goal to the next level and meet the growing market demands.

In our commitment to create customer value at all times, our R&D team continues to innovate with a primary and unstinted focus on reducing the carbon footprint of our products.

How big is the Indian stability chamber market and how fast is it growing?

Though significantly big, we still feel that the Indian stability chamber market is still at its nascent stage.

With most of the mulitnational pharma companies choosing India over China as a cost-effective destination for stability operations, the market is well poised to get bigger. Adding to that is the growing demand of the domestic pharma companies to launch their products in other countries and therefore meet the regulatory market compliance norms.

What role does stability chambers plays in pharma industry?

It plays a critical role. Stability testing and stability analysis has become an important criteria for regulatory bodies these days to ascertain the efficacy and market-worthiness of drug products and drug substances. Degradation of a product prior to its expiry period not only results in failure of therapy but may also result in patient’s death in some of the cases.

Any discrepancies arising out of stability analysis can delay the approvals for the pharma companies to commercially launch their drug product.

What percentage of the market has been captured?

In the domestic market, our market share is approximately 65-70 per cent and growing steadily at 25 -30 per cent per year.

Our international sales has grown at a whopping 100 per cent in the last two years.

With installations of more than 6000 chambers, almost all the leading pharma companies are our customers today.

How many products are in the pipeline and when do you plan to launch them?

We will soon launch the ultra-low deep freezer series. These products will achieve temperatures as low as -80ºC. One of the USPs of these freezers is that they will seamlessly integrate with ICDAS – NEWTRONIC’s 21 CFR Part 11 ready software. Thereby with features of data logging, realtime and comprehensive alarms, audit trails, data trending, e-comments and e-signatures, the customer benefits from a product that complies to the regulatory markets.

What services do you provide to your clients?

Our service programmes are quite comprehensive in nature. It ensures that the customer sees Newtronic as a one-stop solution provider for all the stability requirements. We offer all kinds of after-sales support and services. Chamber commissioning, qualification, documentation (DQ, IQ, OQ, PQ), comprehensive and non-comprehensive AMC programmes, calibration/ validation, chamber upgradations and refurbishing, audit support are some of our offerings in this area.

Our customers (international-based customers) are also greatly benefited by our online support programme, an efficient medium to diagnose and resolve any software programme related issues as well as carry out periodic upgradations.

Our service team spans across all the major pharma hubs of India and globally across 37 countries.

Stability testing is 24/7 and any breakdowns will require the users to file deviations – something that everyone wishes not to! Undoubtedly, after-sales support and service is at the core of our business. They are the most important parameters for the customers to measure our success and their satisfaction levels in using our products. We take pride in the fact that our service support has been greatly appreciated by our customers and majority of them have rated it as fast and effective.

What trend do you see in the market and how fast can Newtronic gain from this opportunity?

Clearly the trend is growth-oriented and very bullish. Under the leadership of the new government, the world is looking at India as the number one destination for investment and growth.

Newtronic is an established brand and a player in the field of stability testing. With our ability to understand and act quickly on customer expectations coupled with an aggressive and customer-oriented workforce, we believe we are ready to bag most of the opportunities in the market today, especially the challenging ones.

What is the strength of your workforce and do you plan to expand it?

We have a workforce of 200. It includes the team at our head-office-cum-plant in Mumbai, at our second upcoming plant in Umbergaon as well as our sales and services team spread all across India and abroad. This workforce is likely to grow by another 15-20 per cent in the coming months.

How large is your international presence and which markets do you plan to tap?

Every organisation seeks to increase its growth beyond the land of its origin. We have expanded our presence in more than 37 countries now. Our international presence is largely in the Middle-East and Far East countries. In this fiscal, our exports division have set targets to tap into newer geographies such as Russia, South Africa and other such emerging markets.

Along with a solid customer base, we have also nurtured the after-sales-support in these countries.

During the last fiscal what was the company’s turnover and how much it is projecting to earn from the current fiscal?

Our turnover will soon hit the Rs 1-billion mark. Indeed, it will be a proud moment for all of us at Newtronic. The sweat and toil in the past three and half decades is reaching a much desired milestone. I take this opportunity to thank each and every one within the industry who has been instrumental in this landmark achievement.

Tell us about the company’s expansion plans.

We have set aggressive expansion plans this fiscal. Expansions are planned not only in the manufacturing facility at Umbergaon but also in other areas. We are doubling our number of branch offices across India. Our sales and services teams are also getting beefed up. We are expanding to other geographies and with our new range of products. So overall, it is going to be an exciting journey for the Newtronic family.

u.sharma@expressindia.com

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