EDITOR'S DESK

  • What’s Process Intensification In Practice?

    I understand why “process intensification” is a buzzword embraced by the vendor and consulting communities. Now I want to know what the term means to biopharma companies, and whether—and how—you’re implementing it.

8 Biotech Startup Lessons From Heat Bio’s Jeff Wolf

With apologies to Tom Petty, as biotechs go it’s the starting that’s the hardest part. No one knows this more than Jeff Wolf, who’s responsible for more than a few biotech startups. We caught up with Wolf for a candid talk on the toughest aspects of birthing a biopharma. 

Can Valneva Do What SmithKlineBeecham Couldn’t?

As marketability goes—and despite a growing unmet medical need—Lyme disease vaccine programs have suffered a futile fate. With its VLA15 candidate, French specialty vaccine company Valneva is trying to change that. Recent positive Phase 2 data bodes well for the effort.

An Inhalable mAb For COVID-19?

An at-home, self-administered, inhalable COVID-19 therapeutic is in the works. Given recent transmission spikes, troubling immunity data, and skepticism of a timely vaccine, it might be a critical tool in the effort to flatten the second curve.

How Ancient Fish DNA Could Contribute To Cancer Therapy

Multiple of this company’s clinical-stage CAR T-Cell therapy candidates for solid tumor and blood cancers took cues from a discovery made by a renowned biologist trying to grow a genetically-engineered super fish. 

GUEST COLUMNISTS

  • A Framework For Managing The Quality And cGMP Compliance Capability Of Your CMOs

    When it comes to current good manufacturing practice (cGMP) compliance, many sponsors lose sight of their responsibility to ensure that each gram or dose of externally derived output fully meets its registered parameters and has been demonstrated by the contract manufacturing organization as manufactured in full compliance with the requirements of cGMP.

  • Advancing The State Of Aseptic Processing: Let’s Get Serious

    It seems pitiful that, for whatever reason, industry has failed to universally adopt more effective technologies to control contamination resulting in safer sterile drugs. On the other hand, the regulators must share substantial blame because of their historically lukewarm acceptance of emerging and even established advanced technologies.

  • Mitigating Risks To Global Distribution Of COVID-19 Vaccines And Therapeutics

    All partners in the vaccine supply chain recognize that the supply chain challenges posed by COVID-19 must be assessed and mitigated. Increased monitoring and corrective and preventive actions of supply chain issues and technical support for analytical challenges need to be addressed.

  • System Impact Assessment: A Risk Management Framework For A COVID World

    Infusing risk management is essential to an organization, especially in terms of facility, utility, and equipment qualification. Although qualification is usually the last step before moving to process characterization and validation, integrating a risk management approach is an effective way to ensure qualification activities are focusing on what matters most — that equipment performs as expected.

  • Moving Beyond Human Error In Biopharma Investigations And CAPA Programs

    Human performance improvement requires special focus and deliberate action by management to move from an old construct of investigating error as a human failure to an new construct where error is a symptom of a problem to be understood, linked to the context in which the error took place, and it is the starting point of the investigation, not its conclusion.

  • Revising Annex 1: A Case Study In Controlling Operating Risks By Understanding Uncertainty

    Unfortunately, the pharmaceutical industry does not understand how to control a risk’s likelihood of occurrence. The current draft of EU GMP Annex 1 is an example of the industry’s focus on a risk’s severity while not understanding or evaluating a risk’s uncertainty and thus defaulting to using the precautionary principle for guidance.

  • Advanced Computing In Pharma & Medtech: How Cognitive Biases Can Cost You Millions

    In their race to leverage sophisticated computing technologies (particularly artificial intelligence, robotics, augmented/virtual reality, and IoT), life science companies face a hidden, insidious challenge — avoiding the cognitive biases that can cause them to unwittingly exacerbate already business-threatening cyber risks.

  • Human Performance In Biopharma Operations — Your Problem Isn’t Error

    This is Part 1 of a two-part roundtable Q&A focused on human performance in pharmaceutical operations. In this part, we discuss key drivers for human performance improvement, compare lean manufacturing and human performance programs, and provide perspectives on human performance in the context of the rapid scale-up and production of COVID-19 therapeutics and vaccines. 

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The world of aseptic systems has evolved faster in the last 5-10 years than it has over the history of the industry. This collection of articles from BioProcess Online covers the major aspects of our engineering concepts, successes and failures. The success and failures are equally important as lessons in our evolution and journey in achievement in this business. We hope you enjoy!

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