Industry Insights

41. Five-Point Checklist For Pharmaceutical Scale-Up 11/29/2016

    Scale-up is an inevitable part of the product life cycle of every successful drug, and each time it is required, a meticulous process must be followed to ensure that the end result is identical to the product formulation as originally devised. A successful drug product may go through a scaling process several times during its life cycle. The laboratory-scale batches used in clinical trials that expand to pilot-scale and finally to commercial-scale production may be just one iteration in a product’s evolution.

42. 4 Key Steps To Build Supply Chains For Later-Stage Clinical Trials In LMICs 3/6/2025

    Gates MRI's head of clinical supply discusses learnings and considerations that he keeps in mind for clinical trial supply chain/logistics.

43. Medtech Consolidation And The Outsourcing Competitive Landscape 7/15/2019

    While consolidation may have somewhat predictable effects in most medtech markets, this trend has a distinct impact on competitors in the outsourced devices market.

44. Meet The Scientist — Dr. Peng Zhang

    While pursuing a career as a medical doctor, Peng Zhang realized there were limited treatments for patients suffering from a variety of diseases. She made the decision to fill that void by focusing on discovering and developing therapeutics.

45. How Do You Streamline Manufacturing Of Your Drug Substance? 6/8/2022

    When developing a drug substance manufacturing process, considering the impurities that are produced is as important as the drug substance itself.

46. New Instrumentation Expands Sediment Velocity AUC's Utility 4/24/2024

    Purified adeno-associated viruses (AAVs) are prepared as a variety capsid species that must be characterized and quantified to ensure safety and efficacy.

47. Effective Environmental Monitoring And Control In Pharma Operations 10/16/2025

    A structured contamination control strategy uses the Plan, Do, Study, Act model, focusing on EMPQ, meticulous planning, trend analysis, and continuous improvement with CAPA and change control.

48. FDA Issues Second DSCSA Warning Letter — What Does This Mean? 8/16/2023

    In June 2023, shortly before final requirements of the Drug Supply Chain Security Act (DSCSA) must be met come November, the FDA issued a warning letter to Safe Chain Solutions, LLC addressing DSCSA violations related to repeated instances of distributing costly counterfeit antiviral drugs that Safe Chain had sourced from unauthorized trading partners. Let's look more closely at the emerging themes so that you can avoid a similar warning letter.

49. De-Mystifying Regulatory Support During Viral Vector-Based Development 4/15/2025

    Navigating clinical trials for viral vector-based cell and gene therapies demands specialized expertise and regulatory insight. Learn how scientific acumen and strategic planning bring innovative therapies from lab to patient.

50. Navigating FDA Guidance: Risk Management Plans For Potential Drug Shortages 9/8/2022

    Recent to "help stakeholders develop, maintain, and implement risk management plans (RMPs) to proactively assist in the prevention of human drug product and biological product shortages."