Outsourced Pharma App Notes & Case Studies

1. Business And Cultural Considerations When Managing Clinical Supplies For Asia-Pacific Studies 2/8/2018

   In addition to careful adherence with all applicable regulatory and Customs requirements, sponsors should understand and be sensitive to the cultural and business norms of each country included in their study.

2. Modular Approaches For Diverse Molecules: Reinventing Smart Bioprocessing 2/23/2018

   Smart bioprocessing uses bioinformatics, lab-scale processing, and analytics to create efficient and cost-effective production processes that can be verified at lab-scale before scale-up.

3. Optimization Of Midstream Cell Lysis And Virus Filtration Steps In An Adenovirus Purification Process 9/10/2018

   Here we describe screening of detergents for release of adenovirus from HEK293 host cells to replace the traditionally used detergent Triton™.

4. Quality By Design Approach To Analytical Method Optimization 12/18/2019

   Quality by Design (QbD) is well established in the pharmaceutical industry for manufacturing processes, including active pharmaceutical ingredients and drug products. The knowledge obtained during development can establish the design space and determine suitable process controls. The novelty of the multivariate approach over the traditional one-factor-at-a-time (OFAT) type of study is the ability to evaluate both the individual factor effects and the factor-factor interactions that can also be significant. In this case study, a QbD approach was used to solve a high-performance liquid chromatography (HPLC) analytical method problem where impurity peaks had shifting retention times making identification and quantitation problematic.

5. Accelerated Manufacturing Of Subunit Vaccines For A Rapid Pandemic Response 8/3/2018

   This application note describes a process for rapid production of recombinant anthrax protective antigen (rPA) in short process time for the manufacture of an anthrax subunit vaccine.

6. Improved Bioavailability Of Trio Medicines In 12 Weeks 2/26/2018

   Learn how a structured 3-step approach can help overcome the challenge of molecular characterization and a limited budget.

7. 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.

8. 4 Ways To Avoid Failure In Phase III Clinical Manufacturing 9/19/2018

   Understanding the challenges in the biopharma space is critical, as the planning you do today dictates the options you have later when the costs — and the stakes — get even higher.

9. Don’t Let Insufficient Data Undermine Your CMO & CRO Selection Processes 2/2/2018

   Selecting a partner is challenging, but with the right information you can simplify your efforts and increase your likelihood of making the best decision. 

10. 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.