Articles by Bikash Chatterjee

  1. CMC And Quality Considerations When Engaging Your CDMO 3/21/2022

    Before pursuing an outsourcing strategy, it is essential to define what processes will be kept in-house and where your CDMO partner will take the lead.

  2. FDA’s 2021 Focus Areas Of Regulatory Science: 5 Trends To Watch 3/19/2021

    Examine key elements from the report “Advancing Regulatory Science at FDA: FARS” that provide meaningful regulatory insight on new and emerging approaches to drug development and governance.

  3. FDA Steps Up Support For Advanced Manufacturing Technologies 2/22/2021

    Examine the potential of the FDA and NIST's MOU to provide critical technical guidance that could greatly standardize the approaches to implementing AMTs, such as those used in continuous manufacturing.

  4. Navigating The FDA’s Emergency Use Authorization Process 5/14/2020

    The FDA has been authorized to grant Emergency Use Authorizations for SARS-CoV-2. This will impact both internal manufacturing and the CDMOs that drug sponsors employ. 

  5. Business Continuity & The Coronavirus: Are Your Pharma Operations At Risk? 3/4/2020

    In the face of a pandemic, the value of a robust business continuity plan cannot be overstated. Organizations should actively evaluate those plans, focusing on service providers and partners. 

  6. New FDA Draft Guidance: Qualification Process For Drug Development Tools 2/3/2020

    The FDA recently issued its draft guidance on the qualification process for drug development tools (DDTs), as part of the commitment mandated by the 21st Century Cures Act. The draft guidance provides a high-level description of the intent and content of the DDT program, but it does not address evidentiary standards or performance criteria for purposes of DDT qualification, leaving it to industry to propose the scientific argument and data package.

  7. Understanding The FDA’s KASA Framework 10/30/2019

    The FDA's Knowledge-Aided Assessment & Structured Application Framework marks an ambitious step forward in standardizing and increasing the efficiency of the drug review process. Here's what it will take for the framework to succeed. 

  8. Pharma 4.0: Building Quality Into Pharma Manufacturing, From Molecule To Medicine 10/1/2019

    A race is being run to create the pharmaceutical manufacturing of the future and with Pharma 4.0, powerful market trends are shaping the running field.

  9. 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.

  10. 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.