Outsourced Pharma App Notes & Case Studies

1. Why Automation Is Essential For Document Control Compliance 10/1/2021

   In medical device development, speed, efficiency, and accuracy with document control processes are a top priority.  Regulators are embracing advancing technologies to effectively achieve their mission of ensuring public health and safety — including enhancements directly related to documentation.

2. Automating Document Control Processes To Comply With FDA And ISO Requirements 8/25/2021

   Your document control system should be agile and scalable to keep up with the changing regulatory landscape. Here, we detail the guidelines and standards that apply, and illustrate how digitizing document control processes is essential for ongoing compliance.

3. Improving Lentiviral Vector Downstream Processing Workflows 8/5/2020

   Lentiviral vectors (LVV) are a common vehicle to deliver genetic material in CAR T cell therapy and gene therapy applications. Production methods have been developed by adapting technologies from the bioprocessing sector. However, these downstream workflows are long, require substantial manual labor, and suffer from low yields of infectious virus. In this article we discuss process development pain points of a modern workflow and ways to address them.

4. Development And Manufacturing Of A Fab Fragment For Clinical Trials 6/1/2021

   In this customer case study, we are focusing on our collaboration with Acticor Biotech, a spin-off of Inserm, the French National Institute of Health and Medical Research, which is advancing an innovative drug for the treatment of the acute phase of ischemic stroke. Acticor selected MilliporeSigma’s BioReliance® End-to-End Solutions for process development and GMP manufacturing of a Fab fragment to support clinical trials. The project timeline allowed only 18 months to get from the cell line to clinical batch manufacturing.

5. Increase Drug Discovery Productivity, Optimize SPR Data Interpretation 9/17/2021

   The need to increase efficiency and productivity has led scientists to develop a machine learning solution that can optimize the way that developers analyze and characterize their early drug candidates.

6. Cold Chain Logistics For Cell Therapy Production – A Conversation With Celyad’s Thomas Lequertier 8/23/2021

   Because cell therapies must be stored and shipped at very low temperatures, maintaining a therapeutic’s integrity through cryopreservation has far-reaching implications for both its efficacy and long-term commercial success. Thomas Lequertier, head of the Cell Therapy Manufacturing Unit at Celyad Oncology, recently sat down with the Business of Biotech podcast to discuss how his company has approached cold chain technology for its CAR-T therapies.

7. Intensified Polishing With Single-Pass Tangential Flow Filtration, Anion Exchange Chromatography 11/19/2020

   Single-pass tangential flow filtration (SPTFF) can be used to drive flexibility, lower cost, and higher product quality. Read the application note to learn more.

8. Enabling Bioprocess Control With Successful Automation Strategies 12/9/2021

   In a recent live event with Bioprocess Online, industry experts at various stages of their automation journey discussed their approach to enhancing quality control and data integrity through automated technologies.

9. Meet The Scientist — Bryan Braxton, Ph.D. 2/5/2021

   Bryan Braxton has a friendly, grounded demeanor and a scientific mind that creates solutions for our most complex aseptic development projects. But how did these two traits combine in the same person?

10. Multivariate Inter-Stage Batch Profile Monitoring And Future State Estimation For Efficient Manufacturing Operations 2/3/2022

    How much quicker and easier would it be if we could know the process’s health by looking at a single metric rather than checking hundreds of parameters?