Outsourced Pharma App Notes & Case Studies

1. Expediting Path To Clinic With OptiForm® Total Supply 7/8/2020

   MGB Biopharma, a biotech company based in Scotland, U.K. was developing a new class of anti-infective medicine based on Minor Groove Binder compounds. Learn how Catalent provided integrated formulation development, clinical trial material manufacturing, and supply and distribution services to ensure successful delivery of the kits to MGB's patients.

2. Modular Bioprocessing Alleviates Drug Manufacturing Woes 4/4/2019

   Building a bioprocessing facility is usually a complicated process and requires partnering with not only drug developers, but also many different experts in various industries.

3. Embracing Biosimilars, They Are Here To Stay 10/10/2018

   The biosimilars market is suddenly booming, with established biopharma giants and nimble start-ups all clamoring for a piece of the action. But such steep competition means that only the wise will survive.

4. Reducing Cost Within Advanced Therapy Clinical Trials 4/10/2019

   The challenge for advanced therapy companies is that they need to develop a supply chain that delivers their therapy, at scale, without adding significantly to the cost of goods sold (COGS). In this case study, you'll learn how a company saw 55% cost savings across its distribution system and increased visibility of its supply chain through utilizing a Total Transportation Management (TTM) system.

5. Considerations For Your First Clinical Trial 9/15/2020

   For a small and emerging biopharma, moving into the clinical trial phase of development can be overwhelming. Tt is important to understand that CROs do not typically manage the comprehensive clinical trial supply chain. This paper reviews seven ‘clinical trial supply best practices’ to help ensure a successful trial.

6. Comparing Continuous And Batch Processing In Downstream Purification 6/10/2019

   Current state-of-the-art continuous manufacturing technologies are being developed and implemented to manufacture a wide variety of products including monoclonal antibodies, recombinant proteins, and other biological modalities. Though upstream fed batch and perfusion bioreactors unit processes are relatively mature, downstream process unit operations are less mature. In this case study, Catalent compared the productivity of purifications running in batch versus continuous mode.

7. CAR-T Cell Lentiviral Transduction By Spinoculation 5/21/2020

   There is a growing need to close and automate manufacturing of chimeric antigen receptor (CAR)-T cell therapies. Learn how to streamline this step while keeping flexibility during process development.

8. Minimizing Errors And Saving Time In Drug Receipt Processes 3/20/2019

   The speed-accuracy trade-off is a well-known phenomenon in psychology for processes requiring human input: the faster you go, the more likely it is that errors will be introduced into the system. 

9. Industry 4.0 Connects Machines And Data 10/26/2018

   By applying remote monitoring, advanced modeling, and optimization of manufacturing processes, Industry 4.0 offers process reliability and product quality through connecting machines and data.

10. Technical Considerations For Developing Oral Solids (Part 1) 8/3/2020

    Navigating your oral solids project from development through commercial manufacture can be a challenging path. In a two-part series, four oral solids experts from Pfizer CentreOne’s global network and partner organizations discuss the technical considerations to be aware of. In this first installment, we look at the importance of technical groundwork and understanding excipients in the early stages of your project.