Industry Insights

81. MAM Solutions For Process, Product Control Of Biotherapeutic Proteins 11/22/2022

    With industry-leading scientific expertise and customer support, we have pioneered solutions to some of the most pressing challenges facing customers interested in adopting MAM into their organizations.

82. FDA Seeks Comment On Delaying, Denying, Limiting, Refusing Inspections 1/9/2023

    The FDA has released for public comment a proposed draft guidance, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection Revision 1. The guidance shares examples of reasonable and unreasonable circumstances. Submit public comments by February 14, 2023.

83. Controlled Nucleation Offers Homogeneity And Batch Consistency 11/24/2025

    Controlled nucleation standardizes freezing across all vials, leading to uniform ice crystals and improved lyo cake quality. This critical step reduces variability and supports robust product scale-up.

84. CDMO Selection: Can We Eliminate The On-Site Audit? 12/15/2020

    On-site capability assessments are an indispensable part of the CDMO selection process. But, due to travel restrictions brought about by the ongoing pandemic, supply chain professionals, as well as development and clinical stage biotech companies that outsource, have no choice but to rethink and re-evaluate this step of the process. 

85. Navigating The Murky Waters Of Patent Claims Involving AI After Amgen v. Sanofi 8/24/2023

    In May 2023, the Supreme Court issued a ruling on the Section 112 enablement requirement for patents in Amgen v. Sanofi. What does this mean for patent claims involving artificial intelligence (AI) going forward? These Haynes Boone attorneys explain.

86. Creating A Roadmap For The Development And Manufacture Of Gene Therapies 5/4/2020

    The cell and gene therapy sector is in need of a similar revolution, but instead of a “standard gauge,” there is a need for clear, evidence-based industry standards and best practices for manufacturing these innovative technologies.

87. Import Product Specifications And Drug Registration Testing For China 10/6/2025

    This overview and its recommendations are valid for drug registration testing (for marketing authorization application in China) as well as import testing (for commercial batches to be imported to China after approval).

88. In-house Or Outsource? 3/18/2020

    This paper addresses five considerations that should be carefully explored when pre-clinical and clinical drug development companies make their manufacturing decision. These considerations are control, cost/available capital, time to market, leverage, and business/monetization strategy.

89. Analytical Considerations For Biopharmas During Commercialization

    As a project approaches its process performance qualification phase, it is crucial to understand the expectations of regulatory agencies and identify the most efficient ways to validate the analytical methods.

90. Streamlining Advanced Therapy Tech Transfer: Balancing Early-Stage Needs With Future Success 8/15/2024

    Streamlining the tech transfer process is a key variable in shortening development timelines and controlling costs, maximizing a molecule's potential for late-stage success.