EDITOR'S DESK

  • 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. 

4 Tips For Biotech Financing From Afar

Gone—for a while, anyway—are the days of pressing the flesh, pounding the pavement, and cross-crossing the conference scene with your pitch deck. Here’s how one successful startup biotech is maintaining its conduit to cash, despite travel restrictions and social distancing.

HQ Move Fuels Fountain’s AI Drug Discovery Machine

Fountain Therapeutics’ unique AI discovery platform prompted an invitation from Eli Lilly & Company to move Fountain headquarters to Lilly Gateway Labs. Here's how company CEO John Dimos, Ph.D. is squeezing the value out of the move, despite its execution during the height of the COVID-19 pandemic. 

GUEST COLUMNISTS

  • 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. 

  • Cleaning Process Development: Selection Of Cleaning Agents For Pharmaceutical Products

    This article will discuss how bench-scale studies can be used for selecting the best cleaning agent for certain products and provide answers to the questions "Which cleaning agent provides the best cleaning?" and "Can we demonstrate that two cleaning agents are equivalent?"

  • Nephrology Sector Of The Immunology Market: A Major Biopharma Development Opportunity

    Most of the development in immunology to date has happened in rheumatologic, dermatologic, and respiratory indications. Nephrology, on the other hand, the medical branch that focuses on kidney diseases, has few approved treatment options outside of those that are expensive and higher risk, such as dialysis and transplants. 

  • Interacting With FDA During Biosimilar Development: From Initial Advisory Meeting To BLA

    In Part 2 of this two-part article, we discuss what information is critical to support the sponsor’s argument that the proposed product is biosimilar to the designated reference product and when is it appropriate and at what level of detail it should be for each stage of interaction with the FDA.

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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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