Industry Insights

  1. Delivering AAV Therapies Via Candidate Screening And Feasibility Studies

    As developers begin their AAV therapy research, opting to conduct early phase studies with an experienced CDMO can help mitigate funding challenges and procure material for clinical data generation.

  2. The Rise Of Complex OSD Generics: Understanding Development Challenges 12/11/2024

    Understanding the potential pitfalls and partnering with the right experts can make all the difference in overcoming the complexities of complex generic OSD development.

  3. Top 10 Most Cited QSR Clauses In FDA FY2023 Medical Device Inspections 4/19/2024

    By proactively addressing recurring deficiencies in Design Controls and risk management, manufacturers can ensure FDA compliance and prioritize patient safety and device effectiveness.

  4. Agile Software Development In Bio/Pharma & Medical Devices, Part 2 7/11/2023

    Part 1 of this article series dived into the use of Agile methodology with a focus on the planning phase of a software development plan. This article dives further and discusses the phases of team structure and collaboration, defining requirements and product definition, software architecture, and more.

  5. Scaling Up Your Methods With USP <621> - Part 1: Chemistry 9/22/2023

    Explore the latest updates to the USP <621> guidelines that involve changes to the allowable modifications to gradient methods and updates to system suitability parameters.

  6. How Recce Is Delivering 5,000 Doses Per Week For Its Clinical Trials 10/25/2024

    Automation and the underlying chemistry of its R327 candidate have helped the antibiotic developer reach notably high production volumes.

  7. Overcoming Commissioning Challenges To Achieve Operational Readiness 10/19/2023

    As the data center market continues to grow exponentially, third-party testing and commissioning have become vital to achieving operational readiness on time and within budget.

  8. Patenting Antibodies: The 4 Tactics To Use In 2021 6/4/2021

    With epitope claims less available post-Amgen v. Sanofi, this article examines four useful approaches that you and your antibody patent lawyer can implement in order to improve your chances of obtaining valid antibody claims with functional attributes.

  9. The Landscape Of GLP-1 Receptor Agonists In Diabetes And Obesity Treatment 2/27/2025

    This article shares an overview of market research on GLP-1 drugs, including the anticipated growth of the market and the current leaders in the space.

  10. Future-Proofing Peptide MAM By Ensuring Scalability And Deployment 2/22/2022

    Knowledge gained through liquid-chromotography-mass spectometry can be transformed into single multiplexed assays for monitoring attributes across development, manufacturing, and release.