• Where Biotech Business Nuance Isn’t Lost

    You read, you watch, you listen, you travel to conferences and events, and you learn from all of it, but none of those are the leading source of information for those who seek it. What medium do most biopharma leaders actively seek when it’s learning they’re yearning? Conversation.

Are Immunotherapeutic Vaccines The Next Biologic Revolution?

Vaxxinity, small as it may be on the greater pharma landscape, is carving out positions as innovator, disruptor, and leader in what CEO Mei Mei Hu, J.D. refers to as the third biologic revolution. Here, she shares Vaxxinity's position on immunotherapeutic vaccines in the context of traditional vaccines and biologics and offers insight into the company's unique culture. 

Master The CMC-To-C-Suite Transition

Sarah Howell, Ph.D. joined Arecor as COO back in 2011. She brought drug development experience—and commercial success—honed at big pharmas including GSK, UCB, and BTG. What she didn’t bring with her was experience in the C-suite. Hers had had been spent on another C-level: CMC. Here's what Dr. Howell, now CEO, learned about the transition.

Nurturing Next-Gen Biopharma Manufacturing Skills

Turning academic interest in biology into careers in biopharma: A look at NIIMBL's commitment to nurturing the skilled workforce the industry desperately needs now—and will need even more as it moves into the development and production of increasingly complex ATMPs and multi-modal therapeutics.

Turning “White Paper Ideas” Into Biomanufacturing Realities

NIIMBL Director Kelvin H. Lee, Ph.D. illustrated the power of consortia and public/private partnerships in advancing next-generation approaches to ATMP manufacturing, and demonstrated how the Institute isn’t just talking — it’s building.


  • A Methodology To Support Particle Investigations In Biopharma Products

    Particles in parenteral products are a major cause of product recalls, and appropriate management of risk from visible particles is vital. This standardized methodology provides users with a decision-making tool to clarify the risks presented by a particle to a batch.

  • 1 Year Out, Where Do We Stand On DSCSA Implementation?

    This month kicks off the final year of a decade-long process to enhance overall security of the U.S. prescription drug supply chain under the Drug Supply Chain Security Act. This article looks at this year’s DSCSA implementation efforts, before examining where implementation currently stands and what gaps and challenges remain.

  • FDA Releases Guidance On Drug Products Containing Nanomaterials

    In the FDA guidance entitled Drug Products, Including Biological Products, that Contain Nanomaterials, “nanomedicine” refers to a drug product that contains at least one component with a dimension in the size range of approximately 1 nanometer (nm) up to 100 nm. Focus of the guidance is on a risk-based regulatory strategy.

  • The Expanding Patent Landscape For RNA-Based Therapeutics

    The COVID-19 pandemic thrust RNA-based therapeutics into the spotlight. Before that, only a handful had received regulatory approval. Why are RNA-based therapeutics seeing more patent activity now and how should biotech companies mitigate patent risks? Attorneys from Neal Gerber Eisenberg share their insights.

  • Biology Meets Computer Science For Next-Gen Biologics Drug Discovery

    We have entered a new age in biologics development, which is undergoing a technological revolution with an increasing focus on software-dependent and data-driven results. Integrating the biological and the computational creates a need for specialists working together in parallel.

  • Frequent Deficiencies In GMP Inspections, Part 1

    It is sometimes astonishing how often pharmas and biotechs "commit" similar or even the same GMP mistakes — in (almost) always the same places. Here are two of the most common pitfalls to avoid: inadequate handling of deviations and inadequate handling of changes.

  • Assessing Quality Of Viral Vectored Vaccines

    While viral vectored vaccines have been previously developed against Ebola virus, the COVID-19 vaccines were the first widespread global application of this vaccine platform. Adenovirus vectored vaccines have unique critical quality attributes that must be tested to ensure quality and safety.

  • The Upper Nasal Space: Drug Delivery’s Next Frontier

    Oral formulations of drugs account for up to 75% of prescriptions. However, many diseases require therapies to provide a maximal benefit as quickly as possible, and oral delivery may result in slow absorption. Enter drug delivery via the upper nasal space, which has the potential to provide a more rapid onset of activity, avoid degradation in the GI tract, and more benefits.





From setting up and implementing a QRM program to objectively measuring your risk appetite and risk tolerances to proving sound risk management through factory and site acceptance testing (FAT and SAT), this e-book offers a collection of fresh insights from biopharma risk mitigation experts to help guide your risk management strategy.

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