• Risk Tool Selection With ICH Q9(R1) In Mind

    This article focuses on the formality concept discussed in the revision of ICH Q9 Quality Risk Management released earlier in 2023. The authors provide a helpful overview of what risk tools are appropriate to use during certain types of scenarios, and what the team composition should look like.

  • Moving From Clinical Stage To Commercial? 4 Steps For An Outsourcing Strategy

    If you're a pre-commercial bio/pharma looking ahead to commercial stage, evaluating partnerships are faced with making key decisions around which capabilities to outsource, the degree of data access and ownership, and which external partners are the right fit. Here are four key actions to consider.

  • Emerging Market Trends For APIs

    The active pharmaceutical ingredient (API) market is estimated at $158 billion in 2023 and is projected to reach $232 billion by 2028. This article shares new market research on APIs, including an analysis of innovative and generic APIs, synthetic and biotech APIs, and more.

  • Your Best Chance At Regulatory Compliance For Combination Products: Integrated Development

    The FDA now defines a prefilled syringe, a product that was at one point considered “packaging” for a drug, as a constituent part of a combination product. The ultimate combination of the drug, its package, and its delivery device means that during development and manufacturing you need to combine both drug and device current good manufacturing practices (cGMPs) and quality approaches.

  • Global Market Trends For Drug–Device Combination Products

    Drug–device combination products, also known simply as combination products, have a wide range of applications, including drug-eluting stents, prefilled syringes with medications, inhalers with drugs, transdermal patches with therapeutic agents, and more. This article shares new market research.

  • New ISO 14644-21:2023 Addresses Reducing Sampling Errors With Airborne Particle Counters

    The new ISO 14644 Part 21 addresses optimizing particle counter accuracy in cleanrooms, focusing on reducing sampling error and particle loss. Discussion includes the use of airborne particle counters, tubing, and isokinetic probes.

  • Survey Results Show What Could Finally Make Sustainability Stick

    Results from BioPlan's "20th Annual Report of Biopharmaceutical Manufacturing and Production" show that lasting sustainability strategies should focus on profitability aspects. That's because, even more than a spirit of stewardship, financial advantages provide a powerful incentive to stick to the plan.


  • Designing Successful Viral Clearance Studies

    A review of studies that involve scaling down individual process steps, and for each step, spiking virus into the specific process intermediate, performing the process step, and measuring the remaining virus.




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.

More Content Collections