Outsourced Pharma App Notes & Case Studies

1. Distributed Biobanking: An End To End Solution For FFPE Tissue Block Management 3/27/2019

   From a historical perspective, there are millions of FFPE tissue blocks in storage and in use today. Most storage process work well for small numbers of samples, but is quickly overrun when thousands of blocks begin to accumulate. A new end to end system has been developed and implemented in several locations worldwide to address the issues encountered with FFPE block storage, retrieval and restocking.

2. Industry 4.0 Connects Machines And Data 10/26/2018

   By applying remote monitoring, advanced modeling, and optimization of manufacturing processes, Industry 4.0 offers process reliability and product quality through connecting machines and data.

3. Validating The Stability And Durability Of Labels After Thawing From Cryogenic Temperatures 2/26/2019

   One important element of working in cryogenic temperatures involves ensuring labels remain intact and securely adhered to packaging after application as product moves from ambient temperatures to cryogenic temperatures to thawing at the point of use. The following study serves as a model for the need to validate label stability and adherence and is an example of the many different types of validation studies we regularly conduct to mitigate risk for customers during all phases of an advanced therapy clinical trial.

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. Create Brand Sustainability With Softgel Technology 2/27/2019

   Keeping an eye on some emerging trends that are shaping society and the pharmaceutical industry can help you meet diverse consumer preferences and potentially extend product lifecycles.

6. Process Economic Simulation For Scalable Production Of Adenovirus 8/3/2018

   This novel process was compared with a reference process in both stainless steel and single-use configurations across various production scales and scenarios. Configurations using single-use equipment wherever possible were more cost-effective than configurations using primarily stainless-steel equipment.

7. 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.

8. Optimizing Cell Culture Media To Increase Cell Culture Titer With Maintained Protein Quality 2/21/2020

   When evaluating media with the goal of increasing titers, it is important to ensure that protein quality is not negatively impacted. So how can this process improvement be performed reliably? It makes sense to use a Design of Experiments (DoE) and empirical approach. Here is an example of how to do it.

9. 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.

10. Effects Of Feeding Strategy On CHO Cell Performance In Fed-Batch Cultures 2/21/2020

    This app note demonstrates a fed-batch process for a CHO cell line producing a mAb. The results emphasize the importance of an appropriate feeding strategy to optimize cell growth and productivity.