Outsourced Pharma App Notes & Case Studies

1. Zydis® ODT Provides Better Treatments 12/18/2019

   Discover how Catalent's oral drug delivery offerings can help get your molecule to market faster. In this case study, learn the many benefits of our product offerings.

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. Standardizing Process Characterization And Late Phase Development 11/18/2019

   Process characterization is an important step in the overall journey of product development. This case study proposes an approach for process characterization for the production of a monoclonal antibody, specifically at the drug substance biomanufacturing step.

4. Meeting Patient Needs Through Expedited Delivery Of Phase I Materials 7/17/2019

   To quickly deliver their product to patients in need, Reneo Pharma found a partner to provide both product development and clinical packaging services.

5. Downstream Process Development For Efficient Purification Of Adenovirus 9/10/2018

   Here, we describe the development of two effective downstream processes for purification of adenovirus from cell culture harvest.

6. Multidimensional Scale-Up Of A mAb Capture Step Contributes To Shortened Time To Market 10/10/2018

   This application note demonstrates a multidimensional scale-up (change of both column diameter and bed height) of a mAb capture step, using the ÄKTA pilot 600 chromatography system.

7. Determination Of Adenovirus Concentration Using Surface Plasmon Resonance 9/10/2018

   The performance of two assays for determination of adenovirus concentration based on surface plasmon resonance (SPR) is demonstrated in this application note.

8. Effects Of Feeding Strategy On CHO Cell Performance In Fed-Batch Cultures Using HyClone™ ActiPro™ Medium And Cell Boost™ 7a And 7b Supplements 2/21/2020

   ActiPro cell culture production medium is intended to be used in combination with Cell Boost 7a and 7b supplements to enhance recombinant protein production in fed-batch or perfusion processes. This work demonstrates the development of a fed-batch process for a CHO cell line producing a monoclonal antibody (mAb). The results emphasize the importance of an appropriate feeding strategy to achieve optimal cell growth and productivity.

9. 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.

10. End-To-End Process For Oncolytic Adenovirus Production 3/20/2019

    Oncolytic viruses constitute a new promising therapeutic approach for treatment of cancer. Here’s an example of a scalable, end-to-end process for oncolytic adenovirus production using modern tools and technologies.