In this video:
Special Address by SM Mudda, MD, Misom Labs
Topic: Preparing for an Era of Innovation

Key Highlights:
+ The learnings of the COVID era brought us to understand that our strategic priority is to adopt digitisation for a better development of the pharma industry

+ Industry 4.0 encapsulates all the digital tools that are changing the ways of pharma manufacturing today

+ One of the emerging tools in these times is a predictive quality analytics tool that forecasts the quality of the products

+ Use of digitisation in manufacturing and quality is going to have a long-standing effect in terms of providing better facilities to patients

+ It is important that digitisation initiatives are built within a company’s quality system and not outside it

The post Special Address by S M Mudda, MD, Misom Labs appeared first on Express Pharma.

Panelists In this video:
+ Viveka Roychowdhury, Editor, Express Pharma & Express Healthcare, Indian Express Group (Moderator)
+ Dr BM Rao, Head – EMQA, ASAT & CQC, Dr Reddy’s Laboratories
+ Dr PK Agarwal, Head: Analytical – Research & Technology, Hikal
+ Dr Veena Shetty, Technical Director – Analytical Development, Reliance Pharmaceuticals
+ Dr Vijaya Bharathi, VP & Head, Analytical Solutions, Aragen Life Sciences

Key Highlights:
+ Dr BM Rao, Head – EMQA, ASAT & CQC, Dr Reddy’s Laboratories:
>> Digitalisation and robotic process automation tools are improving efficiencies in analytical processes across study design, data analysis and documentation.
>> Out of specification (OOS) and out of trend (OOT) results are major challenges in analytical development. We need to optimise study design to tackle them

+ Dr Vijaya Bharathi, VP & Head, Analytical Solutions, Aragen Life Sciences
>> Continuous improvements in analytical development methods and technologies have increased their scope of application. Regulators are also encouraging adoption of new technology to improve quality

+ Dr P K Agarwal, Head: Analytical – Research & Technology, Hikal
>> Companies need to invest in skilling and training to get best results from technological advancements in analytical development.

+ Dr Veena Shetty, Technical Director – Analytical Development, Reliance Pharmaceuticals
>> It is better to build a lot of in-house capabilities in AR&D activities to gain valuable experience and best outcomes

The post Panel Discussion: Current advances in Pharma Analytical Development: Trends and Technologies appeared first on Express Pharma.

In this video:
Session by Vinita Singh, Sr Product Manager, Lab Water Solutions – India & Singapore, Merck

Topic: Make your labs future ready and sustainable!

Key Highlights:
+ Quality of lab water needs to be very consistent for analytical test accuracy

+ Labs of future needs innovation

+ 50% of the labs drive a sustainability program, reduction of greenhouse gas emission is the number one goal and 70% labs consider paying more for greener solutions

+ Reduction of waste, recycling and education are the top expectations of modern-day lab heroes

+ Contract management, remote care and hotline are three digital capabilities in MyMilli-Q by Merck

The post Session by Vinita Singh, Sr Product Manager, Lab Water Solutions – India & Singapore, Merck appeared first on Express Pharma.

In this video:
Session by Shitalkumar Pathak, VP – Analytical Research (Formulations), Glenmark Pharmaceuticals

Topic: Optimising analytical functions for accelerated drug development

Key Highlights:
+ ANDA product development process involves API development and research, formulation development and research, analytical research and development & regulation, among others

+ One must be a partner in development rather than a supporter/service provider, and use scientific acumen to fast track the activities over popular shortcuts

+ There are 4 pillars of analytical development: human resource, instrumentation, analytical procedures and material selection

+ The overall role in analytical research involves method development, process optimisation, stability studies, etc

+ One should be aware of the situation, facilities, training levels, etc; as, by knowing these things, a suitable analytical development method can be created

+ It is important for analytical scientists to have the knowledge about the regulatory requirements

The post Session by Shitalkumar Pathak, VP – Analytical Research (Formulations), Glenmark Pharmaceuticals appeared first on Express Pharma.

In this video:
Session by Mallikarjun Reddy, Associate Director – Quality, Clearsynth

Topic: Dealing with challenges in testing and use of Stable Isotopic Labelled Standards

Key Highlights:
+ Labeled standards are preferred as Internal standards (ISTD) because they improve efficiency of bioassay or quantification method

+ The phytochemical properties of Label standards are almost similar to their unlabeled standards.

+ Deuterated and other isotope labelled internal standard have similar extraction recovery, ionisation response and matrix effect which improves the accuracy of quantification method

+ ISTD also reduces chromatography time, making an assay more robust by increasing the throughput and lowering rejection rates

+ Degree of labeling is very important while selecting an isotopic standard

The post Session by Mallikarjun Reddy, Associate Director – Quality, Clearsynth appeared first on Express Pharma.

In this video:
+ Dr Ranjit Barshikar, CEO-QbD International; United Nations Adviser – Geneva (Moderator)
+ Dr Sujay Rajhans, President & Head of R&D, JB Chemicals & Pharmaceuticals
+ Dr Sandeep Zokande, VP – Analytical, Indoco Remedies
+ Dr Shakil Sait, Associate VP-Analytical Development (API & Formulation), USV
+ Dr Amarnath Chatterjee, Sr Lead Investigator & Head Analytical Development Biologics, Syngene International Ltd

Key Highlights:
+ Lifecycle approach is important as that is where the regulators are focussing today: Dr Ranjit Barshikar, CEO, QbD International; United Nations Adviser – Geneva (Moderator)

+ The next decade is going to be a big thing in terms of pharma quality with the help of QbD: Dr Sujay Rajhans, President and Head – R&D, JB Chemicals and Pharmaceuticals

+ When pharmacopoeia standards are not suitable, companies design a method which is superior to these standards. QbD is such an approach that is designed based on science: Dr Sandeep Zokande, VP – Analytical, Indoco Remedies

+ It is important to incorporate ATPs and CQAs while designing a method, and that’s where QbD becomes important, especially for biologics: Dr Amarnath Chatterjee, Sr Lead Investigator and Head – Analytical Development Biologics, Syngene International

+ An improper design screening of analytical methods has been creating a lot of method-related issues. Implementation of a QbD will make the life of our developers and QC analysts easier: Dr Shakil Sait, Associate VP – Analytical Development (API & Formulation), USV

The post Panel Discussion: Best practices in analytical QbD appeared first on Express Pharma.

In this video:
Session by Dr Sachin Dhondiram Patil, Associate VP, AR&D, Caplin Steriles

Topic: Analytical strategies for complex therapeutics

Key Highlights:
+ CMC issues in analytical methodologies include lack of standardised analytical methodologies for characterisation of complex products

+ Requirements of FDA in product-specific guidelines are very extensive. It is important to meet those requirements before submitting the dossier

+ Novel, more discriminative methodologies developed by the industry are not accepted by the agency since they don’t match USP

+ Analytical method development for complex formulations should consider sample viscosity, sample dilution, particle refractive index and sample temperature

The post Session by Dr Sachin Dhondiram Patil, Associate VP, AR&D, Caplin Steriles appeared first on Express Pharma.