Bioprocessing White Papers

1. The Impact Of Annex 1 (2022) On Sterility Assurance 4/24/2025

   Airflow visualization studies, crucial for GMP compliance, validate unidirectional airflow effectiveness in contamination control. Discover their enhanced role in quality by design and revised Annex 1 guidelines.

2. Rapid Discovery And Characterization Of Monoclonal Antibodies Against The SARS-CoV-2 Delta Spike Protein 4/23/2025

   Delve into the intricate workflow employed for the discovery and characterization of monoclonal antibodies (mAbs) targeting the Delta spike protein.

3. Leveraging Efficiency From CLD To Clinical Manufacturing Of mAbs 4/23/2025

   Discover how our efficient strategies can propel your mAb from discovery to clinical manufacturing in as little as 18 months.

4. Process Analytical Technology In The ADC Bioconjugation Process 4/23/2025

   Integrating Process Analytical Technology into validated GMP processes is complex and costly, which requires thorough validation of equipment and cleaning methods. Explore more about PAT's role in ADC production.

5. How To Take Your Process To A Closed System 4/22/2025

   Understand the critical considerations for implementing closed systems in bioproduction, from vessel selection to workflow customization for optimal efficiency and safety.

6. Enabling mRNA Therapeutic Development Through Enhanced IVT Capping Efficiency 4/16/2025

   See how Codex HiCap RNA Polymerase supports the production of high-performance synthetic mRNA, paving the way for next-generation mRNA therapies.

7. Mastering Technology Transfers: Our Blueprint For Success 4/16/2025

   Uncover how this expert approach to process transfer supports reliable, scalable commercial manufacturing in the rapidly growing biopharmaceutical market.

8. Extractables And Leachables Assessment For Single-Use Systems 4/14/2025

   Efforts to enhance biopharmaceutical manufacturing focus on boosting production capacity sustainably and economically. Explore how optimizing processes with single-use solutions and monitoring leachables ensures product quality.

9. Scaling Up Viral Vector Harvest With Ease And Regulatory Compliance 4/11/2025

   Explore how scalable, high-performance solutions can help you overcome the challenges of large-volume viral vector production and accelerate the delivery of life-changing gene therapies.

10. Optimizing DSP Development: Faster Timelines, Lower Costs, And High-Quality Processes 4/8/2025

    The biopharmaceutical industry faces growing downstream processing challenges in purifying complex biologics efficiently and at scale.