Outsourced Pharma App Notes & Case Studies

1. 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.

2. 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.

3. A Solution To Ensure Quantity & Quality Of The Excipient Polysorbate-80 In Drug Formulations 6/10/2019

   Polysorbate-80 (PS-80) is a surfactant commonly used as an excipient to improve API stability. However, degradation of PS-80 can lead to decreased drug potency or stability, and there is inconsistency in the quality and composition of PS-80 provided by different vendors.

4. Quantitating Binding Similarities In IgG Fcγ Receptor Analysis 5/23/2019

   Critical quality attributes are fundamental to regulatory compliance in drug development and manufacturing. Learn how surface plasmon resonance has been applied for protein characterization of antibody effector function.

5. Controlled Endpoint In Cryopreservation 2/24/2020

   Successful cryopreservation of cells requires a controlled cooling rate. Cooling too rapidly or too slowly could lead to a poorer outcome. This application note demonstrates how controlled-rate cooling is achieved using equipment such as VIA Freeze controlled-rate freezers.

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

   A QbD approach solved a high-performance liquid chromatography analytical method problem where impurity peaks had shifting retention times making identification and quantitation problematic.

7. Innovative, Flexible, And Time-Sensitive Packaging Solutions 9/19/2018

   Given the rapidly changing landscape of today's trials, if sponsors wish to succeed, they must remain vigilant - attending to every detail of the process. Learn how several sponsors achieved success through these case-study examples.

8. The Past And Future Of Managing Raw Material And Process Risks In Biomanufacturing 9/18/2018

   How far have we come in raw material supply management, and what still needs accomplished to ensure the delivery of safe and effective drugs?

9. Why Invest In Emerging Markets Now 10/10/2018

   Unexplored and emerging markets are an attractive prospect for biopharma companies looking to expand. But when it comes to ensuring success, what’s the wisest way to invest?

10. 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.