Outsourced Pharma App Notes & Case Studies

1. Biotechnology Manufacturing Program Management 12/20/2023

   Find out how a global biotechnology manufacturing company executing several interrelated projects achieved critical project objectives while adhering to schedule and financial commitments.

2. Innovative ASD Technology Improves Abandoned Cancer Medication 3/1/2024

   Review this case to learn how one solid dispersion technology lowered patients' pill burdens and demonstrated an improved therapeutic response for Galeterone.

3. Vials Vs. Cryobags For Cryopreservation Of Therapeutically Relevant T Cells 7/20/2023

   Explore how COP 50 mL vials could serve as a basis for cell therapies and storage solution to help facilitate the manufacture and commercialization of cell products.

4. Optimizing The Formulation For A Monoclonal Antibody 8/21/2023

   An emerging biotech company sought help developing a formulation for a monoclonal antibody. Explore how MilliporeSigma delivered an optimized formulation within an aggressive timeline and budget.

5. Accurate HC-LC Pairing And A Close-To-Nature Solution For bsAbs 9/11/2023

   Examine how a proprietary technology ensures high levels of accurate HC-LC pairing without detriment to critical quality attributes such as titer, binding affinity, stability, and immunogenicity.

6. Long-Term Container Closure Integrity Testing Of Vial-Stopper-Seal Combinations 9/3/2024

   The study was designed to investigate CCI over a period of 24 months at ambient, ultra-low and cryogenic temperatures for serum-stopper samples and at ambient temperature for lyo-stopper samples.

7. Aseptic Expertise And Delivery Of Services 8/20/2024

   A pharmaceutical services company sought expert intervention after a routine requalification of their aseptic simulation process revealed a contaminated unit, halting commercial production for two months.

8. Real-Time And In-Line Raman Spectroscopy For Glycan Quality Analysis 6/14/2024

   This study details the use of in-line Raman spectroscopy to monitor mAb glycan profiles within a production bioreactor, highlighting its potential for automation and customization.

9. mRNA Purification Using Anion Exchange Chromatography At Ambient Temperature 12/11/2024

   Explore how anion exchange chromatography with dual gradient elution enables efficient mRNA purification at ambient temperature.

10. Strategic Space Management 8/23/2024

    A pharmaceutical company facing storage space issues decided to outsource its reference samples to Q1 Scientific, a stability storage service provider, resulting in cost savings.