Outsourced Pharma App Notes & Case Studies

1. Biopharma’s Talent Crunch: How To Gain And Retain Skilled Labor 8/23/2018

   What strategies should your company consider for recruiting, training, and retaining qualified candidates in order to remain competitive in a burgeoning biopharma market?

2. Pulse Check: How To Assess Your In-House Biomanufacturing Capabilities 6/18/2018

   By checking the pulse of your organization, you can identify gaps and develop a plan for how to address them, so you can make the right decisions at the right time.

3. Adenovirus Production In Single-Use Bioreactor System 3/8/2019

   Rocking bioreactor systems can shorten the seed train prior to inoculation and provide optimized growth conditions for sensitive cells. This study presents a robust production of adenovirus using such a system.

4. Fujifilm Diosynth Biotechnologies Drives Flexibility And Efficiency In Their Biomanufacturing Platform Using Integrated Automation 8/30/2018

   Through a successful implementation, Fujifilm was able to not only recognize the benefits an integrated automation platform offers but also the importance of working with an experienced partner.

5. Scalable Process For Adenovirus Production 8/3/2018

   This application note describes a process for adenovirus production, from upstream cell culture to downstream purification, using modern tools and technologies. 

6. Zydis® Bio Technology, Grazax® & Grastek®: Revolutionizing Allergy Therapy 12/18/2019

   ALK-Abelló is a global research-driven pharmaceutical company that focuses on the prevention, diagnosis and treatment of allergies. Before ALK-Abelló partnered with Catalent, all marketed allergen immunotherapies were delivered by injection, resulting in a limited patient population and reduced patient adherence. Catalent worked with the client to apply Zydis Fast Dissolve Technology to their therapy, bringing a vastly superior product to market.

7. Managing Risks To Time Critical Product Imports At Clinical Supply Depots 6/11/2019

   Global regulatory standards for clinical trials are, simply put, complex. In this case study, learn how one company worked with its partner to overcome the challenge of a protocol based in the US, an investigational medical product (IMP) approved in the EU, and varying QP (qualified person) rules from country to country, to conduct their clinical trial in Isreal.

8. Case Studies In Supply Chain Management: Getting It Right From The Start 3/15/2019

   Consistent management and communication are the keys to success when managing the supply chain of any advanced therapy clinical trial. In this article, we’ll review two case studies that demonstrate the importance of supply chain management by focusing on scaling up for commercial distribution and on packaging challenges within a cryogenic environment.

9. Can A Shared Biomanufacturing Facility Be The Answer To The Demand Forecasting Dilemma? 8/13/2018

   Using a shared biomanufacturing facility, a biomanufacturer can minimize its investment while mitigating the risks of demand uncertainty and maximizing time to market.

10. Lifetime Performance Study Of MabSelect™ PrismA During Repeated Cleaning‑In‑Place Cycles 10/2/2018

    A demonstration of the long‑term chromatographic performance of MabSelect PrismA during repeated purification cycles using 0.5 M NaOH for CIP.