Regulatory

1. Do Novel Workflows Increase Regulatory Scrutiny? 5/16/2025

   David Bruehlmann, Ph.D. addresses continuous manufacturing in biopharma from the regulator’s perspective before sharing his view of where the technology is going next in this segment of the Bioprocess Online Live event Process Optimization or Full-Scale Automation. We discuss the chasm between the positive perception of continuous versus actual adoption, and discuss upcoming Bioprocess Online Live event programming.

2. Overcoming Cloning Inefficiencies To Accelerate New Protein Therapeutics 10/24/2023

   Watch as a scientist from Advanced Instruments demonstrates how the InstiGRO™ CHO cell culture supplement can be used to enhance clonal outgrowth during single cell seeding experiments.

3. Cell Insights By Umetrics® Studio 12/2/2024

   Cell Insights by Umetrics® Studio simplifies advanced data analytics for bioprocessing, offering hybrid modeling, virtual bioreactor simulations, and cell insights to streamline development, and support data-driven decisions.

4. The ICH Q5A Revision, Its New Scope And Guidance 12/1/2022

   Learn about the ICH Q5A revision addressing viral safety of biotechnology products derived from cell lines of human or animal origin that was recently published for public comment.

5. LC/MS/MS Analysis Of Coproporphyrin 1, Coproporphyrin 3 In Human Plasma 2/17/2025

   This innovative approach holds promise for reducing the need for extensive clinical drug-drug interaction studies, potentially streamlining the drug development process.

6. Meet Your Bioprocess Sidekick For Cell Culture Media Analysis 6/10/2022

   You need rapid and reliable nutrient profiles to make informed decisions, and waiting on that data has detrimental effects on your process. See how REBEL fills the gap.

7. Manipulating Milestones In Pandemic Times With AGTC's Sue Washer 12/21/2020

   The COVID-19 pandemic continues to disrupt biopharma clinical trials, especially those conducted with at-risk patient populations. From patient recruitment to data collection, clinical trials execution became considerably more challenging in 2020. On this episode of The Business Of Biotech, AGTC CEO Sue Washer gives us a behind-the-scenes look at the creative measures her company took to serve a geographically dispersed clinical patient population and ensure her company met clinical milestones.

8. Optimized Purity Of A Monoclonal Antibody, Carsten Voß Video 4/12/2016

   Purity, recovery, and elution volume are important factors and parameters when screening multiple media (resins) for the development of efficient, robust, and economical production processes.

9. Nanoassemblr Ignite mRNA Vaccine Demo 4/13/2022

   The Ignite with NxGen Technology embodies everything that made the NanoAssemblr Platform the go-to for nanomedicine development for over 200 biopharma companies, while bringing the latest innovations developed for the cGMP system to the bench — saving time and money.

10. Cellicon™ Filter And Controller For N-1 Seed Train Intensification 1/14/2021

    Perfusion operations deliver high density cell cultures that alleviate the burden of processing large production bioreactor volumes while increasing manufacturing flexibility. Discover Cellicon™ Filter and Controller, specifically designed for N-1 seed train intensification.