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

  • 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 whether it is implemented and becomes an effective measure to sustain the biosimilar market is 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 New U.S. & EU Guidances On The Combination Product Approval Process
    Comparing New U.S. & EU Guidances On The Combination Product Approval Process

    The 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 by each regulatory body to adequately regulate combination products. In Part 2 of this two-part series, we cover the European Union guidelines for combination products and show how the U.S. and the EU diverge.

  • Facilitating Data Integrity Through Risk-Based Confirmation Of Performance
    Facilitating Data Integrity Through Risk-Based Confirmation Of Performance

    We in pharma and biopharma are required to verify or check or double-check an action or event to be sure it was performed and performed correctly. But what do these words really mean? How do they differ in terms of their actual execution?

  • Pharma 4.0: Building Quality Into Pharma Manufacturing, From Molecule To Medicine
    Pharma 4.0: Building Quality Into Pharma Manufacturing, From Molecule To Medicine

    One of pharma’s greatest foibles as an industry has been the penchant to focus on the wrong things. We saw this with process analytical technology (PAT), where we focused on the design and implementation of the technology and ignored the impact of foundational material characterization and supplier control. Pharma 4.0 has the potential to fall into the same trap.

More From Our Guest Columnists

BIOPROCESSING WHITE PAPERS

  • Shifting The Biomanufacturing Paradigm: Intensifying Upstream Processes

    Demand for mAbs creates pressure to accelerate development, improve flexibility, and reduce costs while sustaining or improving drugs.This paper explores upstream strategies to increase protein titers, which can translate into higher throughput, improved flexibility, and compressed timelines.

  • 6 Regulatory Changes Affecting Bioprocessing In China

    This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays.

  • Corynex Protein Expression: Simplifying Recombinant Protein Production

    The rise of biologics is having a dramatic impact on how physicians treat many serious and chronic illnesses. Pharmaceutical companies looking to add biologics to their pipelines must come up with innovative ways to approach drug development and cut the high costs associated with it. In this white paper, we review how the Corynex® Protein Expression System uses an extensive toolbox to improve the levels of protein secretion and overall success rate.

  • Cold Chain Qualification: 5 Questions You Must Ask When Shipping Biologics

    Organizations recognize the growing need for control of the entire cold chain as the changing global scenario requires highly efficient processes and flexibility.

  • 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.

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.

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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
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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
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