Articles by Bikash Chatterjee

11. Analytical Testing Strategies For Clinical And Commercial Operations 4/3/2019

    A summary of a survey designed to better understand the factors considered when establishing an analytical-testing strategy for clinical-material release.

12. Considerations For Biologic Drug Substance And Drug Product Testing 4/16/2018

    While the FDA does not explicitly define the testing required as a product moves through its development life cycle, recognized standards provide guidance based upon where you are in your drug development and clinical program. This article focuses on the considerations for building a testing strategy for a drug product when using a CMO.

13. Biopharma 4.0: A New Framework & Process For Digital Quality Management 11/6/2017

    Contrary to how it sounds, controlling information is not about withholding key documents or facts that are relevant to the CMO bidding process to see how the bidders react, or only supplying pertinent information if requested. In fact, it is exactly the opposite is true.

14. 4 Key Considerations When Engaging A New GMP Contract Service Provider 4/12/2017

    This article explores what is important when establishing an effective relationship with a CSP as the program moves from product and process design to commercial manufacturing.

15. FDA's New Quality Agreement Guidance: What It Says (And What It Fails To Say) 3/10/2017

    FDA’s new guidance for industry Contract Manufacturing Arrangements for Drugs: Quality Agreements specifically addresses seven elements that should be included in a quality agreement: quality unit activities, facilities and equipment, materials management, product-specific considerations, laboratory controls, documentation, and change control.

16. FDA's New Quality Agreement Guidance — What It Says (And What It Fails To Say) 2/1/2017

    In November 2016, the FDA issued new guidance for industry titled Contract Manufacturing Arrangements for Drugs: Quality Agreements. This guidance is timely, given the rise of the virtual biotech company in the development landscape. Most development programs now include the support of at least one contract service provider (CSP) for services that vary from early development contract research to commercial manufacturing and analytical support.

17. Effective Risk Management: A Catalyst For Quality Performance 6/8/2016

    When we think of risk in the context of drug development and manufacturing, it is human nature to associate any risk-based approach with adding risk to the decision or process. This guidance laid the foundation for two important concepts that influence how we develop and guarantee the quality of our drug products today.