Industry Insights

1. India To Regulate All Medical Devices 3/25/2020

   Expansion of notified device categories is poised to benefit savvy domestic and Western medical device companies by cutting out cut-rate operations.

    

2. Meeting Demand: Small-Volume Mammalian Cell Culture Manufacturing 10/8/2024

   As demand for biologics rises, small biotechs and academic researchers face challenges finding CDMOs that specialize in small-scale mammalian cell culture for preclinical and early clinical trials.

3. Self-Deception — The 3 Most-Repeated Lies Of Trial Master File QC 7/12/2018

   Achieving inspection readiness means that during all stages of a clinical trial, a regulatory inspector would be able to walk into the building and reconstruct the trial using only the documents and metadata present in the trial master file (TMF). Although the concept of an inspection-ready TMF may be simply described, inspection readiness is not easily achieved. The failure to achieve an inspection-ready TMF continues to be an area of growing risk for the clinical research industry.

4. Producing Customized Viral Vectors That Respond To Market Demands 1/4/2023

   Plug and play platforms can be adapted to different therapeutic genes without starting the development from scratch for each product, making the transfer to GMP as fast and smooth as possible.

5. The Role Of Supply Agreements In Life Sciences Manufacturing 11/4/2021

   In light of the disruption and the urgency around fast delivery of high-quality products, it makes sense that manufacturers and their suppliers might reassess their relationships and obligations to one another to manage the results of disruption to supply chain partners. Working with your supply partners to achieve their obligations starts with understanding your company’s existing supply agreements.

6. Best Practices For Designing And Running Clinical Trials For Patients With Rare Diseases 5/25/2021

   As an industry, we are constantly searching for ways to improve the drug development process – particularly in the rare disease space. One way to improve on running your rare disease clinical trial is to foster collaborative partnerships with patient advocacy organizations and to stay connected to patients throughout the trial. Here's how to do that.

7. Facilities Remediation, Renovation & Reconstruction: When Does It End? 2/7/2022

   We sit at the beginning of 2022 amid the industry’s frantic and hurried effort to acquire, expand, and prepare more aseptic plant capacity — and to make it useable, compliant, and productive. This article provides a deep-dive on planning and design for your project, including walls, floors, ceilings, interstitial and mechanical spaces.

8. Vaccine Manufacturing: Harnessing Lab Deviations 9/8/2021

   For National Immunization Awareness Month, we're highlighting timely vaccine manufacturing-centric content such as this from Tunnell Consulting's Bob Johnson. The presence of deviations may seem inevitable, yet COVID has brought to light the question of how vaccine manufacturing sites can manufacture more vaccines, more efficiently. This article explains how.

9. Strike The Balance Between Cost-Effective And Risk-Averse Biologic Manufacturing 12/12/2024

   As drug sponsors continue to navigate increasing global demand for complex biologics, it is vital to assess which outsourcing strategies mitigate risk while maintaining budgets and timelines.

10. A Deeper Look At What's Driving Dependence On Biotech Contract Manufacturers 4/19/2024

    Are you struggling to find CDMO capacity? Here are some of the drivers behind the contract manufacturing market's exponential growth.