Biosimilar Manufacturing solution center

1. A Regulator Looks Back On What We Learned From Accelerated SARS-CoV-2 Neutralizing mAbs Development 3/29/2023

   Prior knowledge, platforms, parallel backup programs, and strategic timing all come into play when rapidly scaling up a mAbs development program in response to a public health emergency.

2. Depth Filtration Devices For Cell Cultures, Fermentation Broths, And Cell Lysates 3/27/2023

   Typically, devices containing depth media filters can offer more efficient filtration. Browse depth filtration products and devices for the downstream processing of cell culture solutions, fermentation broths, and lysates.

3. Increase In FDA Inspections + Whistleblower Complaints = Heightened Compliance Scrutiny 3/27/2023

   We are seeing a significant increase in manufacturing facility inspections by the FDA and other health authorities globally. We are also seeing an uptick in whistleblower complaints. Why? And how can you navigate it? This article examines the issue.

4. A Brief Overview Of Vaccine Purification Technologies And Analytical Tools 3/23/2023

   Downstream processing remains a major bottleneck for vaccine production, and the industry is racing to develop new purification technologies. Here's a snapshot of where we stand and of what needs to happen next to increase quality and yields.

5. Best Practices For Cell Culture Media Fingerprinting 3/13/2023

   This three-tier approach to cell culture media fingerprinting helps you to define an alternative method that will allow verification of the quality of the medium as well as fingerprinting. It helps you to choose suitable methods for incoming ID testing based on raw material properties, goals of media characterization, and the resources available. 

6. Dispelling 4 Common Myths Of Data Quality Governance 3/9/2023

   Achieving robust data quality governance doesn't need to be an unwieldy prospect. Here, we dispel the four common myths of data quality governance and share the three phases of a good data quality governance program.

7. ICH Guideline Q9(R1) On QRM, Part 2: Subjectivity & Supply Continuity 3/7/2023

   The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management, Q9(R1), was adopted on January 18. This article focuses on the guidance's new topics of subjectivity and the role of QRM in addressing product availability risks.

8. TFF For Laboratory And Process Development Applications 3/1/2023

   Learn about the basic principles that govern tangential flow filtration (TFF) along with the use of TFF capsules and cassettes in laboratory and process development applications.

9. Tangential Flow Filtration System Coupling To Enhance Solution Offerings 3/1/2023

   Discover a simple, easy, and versatile method for capsule and depth filtration of small volumes that moves research from cell harvest to purification as quickly and efficiently as possible.

10. ICH Guideline Q9(R1) On QRM, Part 1: Formality & Risk-based Decisions 2/28/2023

    The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management (QRM), Q9(R1), was adopted on Jan. 18, 2023. While the primary principles of QRM in this new version remain consistent with the original 2005 document, the revised guidance has four new subsections. This article examines the topics of formality and risk-based decisions.