Regulatory

  1. GLP And The Impact To Start Up Companies 4/18/2022

    Good Laboratory Practice is often used in laboratories and is necessary for specific investigations. What does it mean? And how can it help start-up companies? Watch this video to learn more.

  2. C&G Regulatory Guidance with Lineage Cell Therapeutics' Brian Culley 6/23/2024

    When we last caught up with Brian Culley, CEO of Lineage Cell Therapeutics, it was January 2021. A pandemic was raging. His company was moving mountains to keep its OpRegen dry AMD clinical trial together and did so despite lockdowns that kept a largely aged patient population from setting foot anywhere near a healthcare clinic. On his long-overdue return to the Business of Biotech, Culley opens up on how the company addressed struggling programs, wrestled manufacturing control issues and delivery inefficiencies in its spinal cord program to the ground, and maintained control of its regulatory progress along the way.

  3. Seal-Sensor Technology For In-Line Pouch Seal Inspection 11/16/2021

    PTI is integrating the latest technologies for inspecting pouch seals utilizing a method that inspects and analyzes pouch seals non-destructively. Seal-Scan and Seal-Sensor utilize Airborne Ultrasonic Technology (ABUS) that inspects and analyzes pouch seals non-destructively.

  4. Accelerating The Development Of New Protein Therapeutics 11/13/2023

    With Foetal Bovine Serum out of the picture, how do we support cells during cryopreservation and revival to accelerate workflows and reduce costs?

  5. Delivering Top Quality Fill Finish Manufacturing

    Bringing an innovative parenteral drug product to market requires a fill finish manufacturing partner with the resources and solutions to deliver top quality products and the agility to meet your needs.

  6. How Vaccines Are Made and Manufactured: Viral Vector Platform 7/28/2020

    Viral vector-based vaccines constitute a promising part of the biopharmaceutical pipeline, addressing many unmet indications. Some estimates show that half of the front runners of vaccine candidates for COVID-19 have used the viral vector platform. Moreover this is a complex platform with more than 40 vectors being used for both gene therapy and vaccines. Watch this video to learn how vaccines are manufactured using a viral-vector platform.

  7. The Blazar® Platform In A Minute 3/12/2021

    The Blazar® Rodent Panel from the BioReliance® portfolio can speed cell line characterization and bulk harvest lot release testing. This degenerate PCR-based method accelerates characterization by reducing timelines by up to 80% and replaces the use of animals.

  8. NovaSeptum® GO Sterile Sampling: Total Cost Of Ownership 8/24/2020

    Risk of contamination associated with traditional sampling methods using SIP valve/welding can have a financial impact on your process sampling plan. Find out how much NovaSeptum® GO sterile sampling system can save you by reducing operator related costs while drastically reducing sample contamination risk and sample loss.

  9. Can You Run Crude Samples Using An SPR Instrument? 2/17/2022

    We explore a common misconception and provide examples of complex material being used in an SPR system.

  10. Who's Defining CMC Requirements? 4/17/2023

    CMC experts discuss what forces and organizations are defining CMC requirements for biologic therapies moving forward.