Outsourced Pharma App Notes & Case Studies

1. Adeno-Associated Virus (AAV) Production Using Microcarriers 6/2/2021

   After comparing adherent, suspension, and microcarrier culture for AAV production, scientists believe microcarrier culture is suitable for production of viral vectors to support gene therapy manufacturing.

2. Microcaps Exceeds Stringent Requirements Beyond Taste Masking 10/27/2020

   A particularly bitter pediatric macrolide in powder form had many needs beyond just taste masking. Read how, by combining double coated Microcaps particles with an excipient mixture, all requirements were met and, in most cases, exceeded.

3. Clinical Supply Optimization: Enhanced Service Model Saves Client Time On Supplies 12/26/2019

   The Vice President of manufacturing for a clinical-stage biopharmaceutical company faced an avalanche of work when a reorganization left him without a clinical supply manager. Planning to start 5 new clinical trials in 6 months while managing quality assurance, manufacturing, and supplies for new and ongoing studies, he turned to his Fisher Clinical Services account executive with a simple question: “How am I going to do all that?”

4. How Should You Prepare For Foreign FDA Inspections During COVID-19? 2/25/2021

   As the COVID-19 pandemic continues, it is important to understand the expectations of regulators about how to facilitate paper-based facility inspections in lieu of those performed on site.

5. Dissolution Development Of Parvulet® Technology Oral Tablets 4/19/2021

   With the development of a dissolution method for a patented oral dosage form capable of being dispensed to patients in tablet or powder formats and converted into a semi-solid through activation with water, it is necessary to study the possible dissolution artifacts.

6. Introducing N-1 Perfusion To Intensify The Seed Train At A Higher Starting Density 5/13/2021

   A high-density N-1 seed culture can improve your fed-batch process by allowing you to seed the production (N) bioreactor at a higher starting density or to replace a large N-1 bioreactor.

7. Pluripotent Stem Cell Expansion And Scale-Up 8/5/2020

   Upstream process development is complex for stem cell therapies, because these therapies involve many manipulations during cell differentiation or even cell engineering. Decisions made early in research will impact the entire product life cycle, so it is important to consider a good process design early on.

8. Formulation Of Aqueous Core Poly(lactic Acid) Microcapsules 10/27/2020

   Poly(lactic acid), or PLA, is a biodegradable, biocompatible polyester. The ability to make microcapsules with a thin PLA shell, however, is non-existent in the controlled release space. Here, using a proprietary Stratμm™ technology, we have created 50 μm capsules with an aqueous core and thin PLA shell.

9. Outsourcer Engagement Preferences – No Love For Linkedin 10/1/2021

   It’s April 2020 and the world is in lockdown. You’re the chief marketing officer of a top-30 CDMO and you’re scrambling to come up with a way to pivot your marketing strategy to this new fully remote world. Most of your ideas reduce to the proverbial kitchen sink approach: throw everything online. So now, 18 months later, how well did it work?

10. How Can CDMOs Identify Their Customers' Decision-Making Process? 6/1/2021

    The Client – ISR was engaged by the Global Marketing Director at a Top 20 CDMO with the above question. The client had years of experience in marketing their brand to prospective customers and wanted to demonstrate to company stakeholders that their marketing efforts were not only hitting the right targets, but that the language used in those efforts reflected their customers’ needs. Knowing this information would allow the client’s marketing department to move toward messaging focused on how their services address their customers’ concerns.