• 3 Strategies For Small & Midsize Biotechs To Launch Drugs Successfully

    Small and midsize biotechs can no longer rely on traditional commercial models. Launching new drugs is one of the most critical phases in the product life cycle, and often these entities’ entire existence depends heavily on a successful rollout. This article shares trends and three strategies for success.

  • Biopharma Facility Modular Design & Construction: Key Considerations

    In terms of facility design, the term “modular design block” is used for “pre-engineered” or “predesigned” solutions. This approach suggests that a new facility design need not be unique but can use and leverage a pre-engineered set of component pieces. The further down the supply chain that standardized modules and components reach, the wider the benefits to the entire industry.

  • A Practical Guide To Navigate The EU's Revised GMP Annex 1

    The EU's final version of the GMP Annex 1 is now published, and it's time to take action. This article shares a road map to navigate what is new and different, how to document your "known unknowns," and more. Quality risk management and a contamination control strategy will be key.

  • 5 Steps To Avoid Mismanaging Biopharma Grant Funds

    You've finally received the grant you need to make your biopharma business a reality. The tough part is over, right? Not exactly. If you mismanage your funds, you could end up on the government’s naughty list.

  • Replacing The MAC/MACO With The MSC: Rethinking How Cleaning Validation Limits Are Calculated

    Two of the most commonly used terms used in pharmaceutical cleaning validation are the Maximum Allowable Carryover (MAC or MACO) and the Maximum Safe Carryover (MSC). This article provides the historical development of both terms and why we should replace the MAC/MACO with the MSC.

  • Biotech 2016 To 2022 And A Look Ahead

    The last five years have been disruptive regardless of sector, yet biotech managed to weather the storm. This article looks at the past five years in the industry from a macro view and shares what biotech executives should consider in the months ahead.

  • Attributable Data Integrity in Modern Biopharma Using ALCOA Principles

    This article is the first in a five-part series providing contemporary, practical, and useful examples of data integrity within each of the five traditional principles of ALCOA. This article centers on A: Attributable.






The debate over whether the biosimilar regulatory paradigm can shift away from comparative efficacy trials has intensified over the past few years. This collection of articles serves as a snapshot of the many different components of this ongoing discussion.

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