EDITOR'S DESK

Does Gender Disparity In Biotech Really Matter?

Why it does, and how one startup is winning the biotech talent wars with a diversity-centric strategy.

AbbVie’s Dr. Howard Jacob: Improving The Drug Pipeline With Genomics

The relationship between therapies and genetic composition is incredibly important to the future of medicine, and the way it's manufactured. I sat down to discuss the topic with Dr. Howard Jacob, who's working to improve the drug pipeline at AbbVie using genomics tools.

Inside NIIMBL And Its New FDA Partnership

Last month, the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) announced that the University of Delaware, on behalf of NIIMBL, has entered into a Collaborative Research and Development Agreement (CRADA) with the FDA. Effective July 15, the agreement gave FDA and NIIMBL the ability to “collaborate in a pre-competitive environment to strengthen research, innovation, training, and collaboration in the biopharma manufacturing industry.”

A Second Reformation: Returning Biosimilar Regulations To Scientific Roots

In light of BioApproval's Chris Webster’s recent publication and future presentation at the upcoming DIA Biosimilars conference, I spoke with him to learn more about the "Confirmation of Sufficient Likeness" approach and the scientific evidence that has informed this proposed biosimilar regulatory paradigm shift away from Totality of Evidence.

More From Our Editors

GUEST COLUMNISTS

  • How Pharma Manufacturers Must Prepare For The New EU MDR And IVDR Environment
    How Pharma Manufacturers Must Prepare For The New EU MDR And IVDR Environment

    Pharmaceutical companies producing combination products or companion diagnostics may not have a clear idea of how the EU Medical Device Regulation (MDR) and the EU In Vitro Device Regulation (IVDR) will effect their products. However, under the new regulations, no medical device will escape regulatory scrutiny, regardless of whether its function is central or ancillary to the drug product.

  • An Introduction To Prefilled Syringe Selection — Prefilled Syringes With Staked-In Needles
    An Introduction To Prefilled Syringe Selection — Prefilled Syringes With Staked-In Needles

    This is the second part of a two-part article exploring various types of prefilled syringes (PFSs) for biopharmaceutical products. Part 1 looked at needle-free and dual-chamber prefilled syringes, discussing the important aspects of those devices. In this part, we will examine the various aspects of prefilled syringes with staked-in needles and their impacts. We will conclude with some general thoughts on vendor selection for successful partnership.

  • The Need For Enhanced Control Strategies In Biopharma And Biosimilar Production
    The Need For Enhanced Control Strategies In Biopharma And Biosimilar Production

    For many years, the pharmaceutical industry  meant “small (usually synthetic) molecules” mixed with various non-active materials and put into capsules or, in the old days, rolled into pills or pressed into tablets. While synthesizing the APIs (active pharmaceutical ingredients), formulating the dosage forms, and analyzing the materials at every step of the life cycle was not always trivial, it was relatively straightforward.

  • ISO 22519: An Unnecessary, Faulty, And Confusing Standard
    ISO 22519: An Unnecessary, Faulty, And Confusing Standard

    The ISO Standard 22519 claims to be the new word in purified water (PW) compliance. In fact, the standard neither promotes innovation nor compliance. On the contrary, it brings confusion to those that are embarking on purified water production and use in the pharmaceutical industry.

  • A Due Diligence Checklist For Leasing A Biotech Manufacturing Facility
    A Due Diligence Checklist For Leasing A Biotech Manufacturing Facility

    The road to successfully acquiring a property for a biotech startup is littered with potholes and barriers. After the operating organization decides that leasing is the most economical approach, the search should focus on the technical merit of the property and the features it offers. This article provides a technical due diligence checklist that the operating organization can use to frame its decision-making process.

  • Biosimilar Automatic Substitution In The EU5: Current State & Future Outlook
    Biosimilar Automatic Substitution In The EU5: Current State & Future Outlook

    At present, automatic substitution of biosimilars at a pharmacy level is not practiced in the EU5. Recent and future changes in the EU5 market access environment and regulatory landscape may favor automatic substitution, but implications on the biosimilar market are yet to be determined.

  • FDA FY2018 Drug Inspection Observations And Trends
    FDA FY2018 Drug Inspection Observations And Trends

    The FDA recently published GMP drug inspection data from CDER that addresses drug inspections conducted during the agency's 2018 fiscal year. This article examines the FY2018 data and evaluate six years’ worth of trends in FDA GMP inspection enforcement.

  • Comparing U.S. & EU Guidances On Combination Product Approval ProcessES
    Comparing U.S. & EU Guidances On Combination Product Approval ProcessES

    New EU draft guidance, Guideline on the quality requirements for drug-device combinations, and U.S. draft guidance, Principles of Premarket Pathways for Combination Products, are the latest attempts to regulate combination products. In Part 2 of this series, we cover the EU guideline and show how two diverge.

More From Our Guest Columnists

BIOPROCESSING WHITE PAPERS

  • Application Enhancements For The HyPerforma S.U.B.
    Application Enhancements For The HyPerforma S.U.B.

    With many end users now demanding streamlined operations, high-density culture in fed-batch modes, even higher production by perfusion cultures, and contrastingly gentle operations required in microcarrier applications, standard S.U.B. offerings must keep pace with the ever-evolving needs of the bioprocessing industry. Read about recent enhancements that are helping keep up with these increasing demands.

  • Biosafety Considerations For Single-Use Bioreactors

    Single-use bioreactors are widely accepted in the pharmaceutical industry and are increasingly being used to perform mammalian cell cultures in commercial manufacturing applications. They address some of the key challenges the industry faces by decreasing time-to-market, reducing validation efforts, increasing flexibility, reducing investment costs and optimizing cost of goods.

  • A Molecule’s Journey – Break Down Roadblocks To Commercial Success

    A guide for today’s biopharma executives seeking to navigate through the important considerations necessary to successfully build their own cGMP biomanufacturing facility.

  • Optimize Sourcing And Standardization Of Cross-Program Parts

    The costly proliferation of parts and components that often accompanies the pressure for product differentiation and customization can be controlled through multiple strategies. One of the easiest and most effective of these is to deploy EXALEAD Sourcing & Standardization Intelligence. By combining information sources with semantic information, these new products and applications go beyond the limits of conventional analytics solutions and deliver simple user experiences for decision makers.

  • ICH Q12 Updates: Increasing Efficiency Of Post-Approval Changes

    Through proper implementation of ICH Q12 tools and enablers, the industry could manage CMC changes effectively under a company’s pharma quality system with less need for oversight prior to implementation.

  • Preparing For Your CDMO Selection Process

    Finding the CDMO that is right for your company and project can be a daunting task, particularly if this is your first time outsourcing. Some companies, especially those with limited experience in the biopharmaceutical industry, may find themselves unprepared when it comes to beginning the search.

More Bioprocessing White Papers

BIOPROCESS ONLINE CONTENT COLLECTIONS

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Download this free collection of articles and learn how to let go of legacy aseptic filling line equipment, seven common filling blunders and how to avoid them, nontraditional design concepts for CAR T processing, what to do when your isolator is taking too long to de-gas. Herman and Erich Bozenhardt bring a collective 54 years of bioprocess facility design and production experience to the pages of this comprehensive ebook.

More Content Collections

LIFE SCIENCE INDUSTRY EVENTS

Writing Effective 483 and Warning Letter Responses October 23 - 23, 2019
1pm-2:30pm EDT, Online Training
BioNetwork October 23 - 25, 2019
CA
BioProduction 2019 November 5 - 7, 2019
Frankfurt
Cleanroom Microbiology – A Foundational Introduction November 5 - 5, 2019
1pm-2:30pm EST, Online Training
Eppendorf Bioprocess Workshop BTEC, NC November 6, 2019
BTEC, NC
More Industry Events

TRAINING COURSES

Writing Effective 483 and Warning Letter Responses October 23 - 23, 2019
1pm-2:30pm EDT, Online Training
Cleanroom Microbiology – A Foundational Introduction November 5 - 5, 2019
1pm-2:30pm EST, Online Training
21 CFR Part 11: Understanding the ERES Regulation for Compliance Success November 13 - 13, 2019
1pm-2:30pm EST, Online Training
More Upcoming Courses