Outsourced Pharma App Notes & Case Studies

1. Scale From Cell Factory Systems To A Bioreactor Without Affecting CQAs 12/20/2021

   The challenge was to identify an effective, replicable, and large-scale LVV manufacturing process to meet the growing manufacturing demand without affecting critical quality attributes.

2. bluebird Bio's Scott Cleve On New Therapies, New Regulatory Approaches 10/4/2021

   bluebird bio's Scott Cleve sat down with The Business of Biotech podcast to talk about shifting regulatory standards and how pharmas can adapt how they engage with regulators.

3. 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.

4. Consistency And Compliance: Cell Therapy Automation Software 4/30/2021

   Automation offers new options for flexibility and optimized biologic production, improving safety, quality, and compliance while advancing patient care.

5. Investing In Capacity – API Commercial Manufacturing 1/20/2022

   A pharmaceutical company sought a CMO partner with commercial manufacturing capabilities and expertise and exemplary quality systems to find a cost-effective process to produce the API for a new drug.

6. Developing A Novel Approach To Real-Time Monitoring Of Antibody Titer 11/22/2021

   As the industry continues to apply innovative manufacturing tools and solutions, it also needs real-time monitoring to keep up with a modern production suite. 

7. BEH C₁₈ Batch-To-Batch Robustness For The Analysis Of Rosuvastatin And Impurities 6/30/2022

   The main goal of this study is to investigate the long-term batch-to-batch reproducibility of 10 different lots of XBridge BEH C₁₈ Columns. Discover the findings of this study. 

8. Achieving Large-Scale Ophthalmic Production 11/10/2021

   Ophthalmic treatments require a manufacturing partner with the expertise, quality assurance practices, and modern equipment necessary to ensure a safe, effective drug product.

9. The Importance Of CDMO Capacity For Viral Vectors: A Conversation With Forge’s Dr. Timothy Miller 10/4/2021

   In this episode of The Business of Biotech, Forge Biologics' Dr. Timothy Miller talks about the importance of increasing specialized CDMO capacity for cell and gene therapy applications.

10. Manufacturing Expenditure By Activity 7/6/2021

    Learn about the competitive activities that clinical manufacturing sponsors spend the most money on, providing some insight into the clinical manufacturing market and where it’s heading.