Outsourced Pharma App Notes & Case Studies

1. 6 Reasons You Don’t Use Market Research 2/28/2020

   Let’s set the scene: You’ve got a project. It’s probably not the most important thing you or your company will do this year but it’s meaningful. There’s a real chance to move the needle with this one. Maybe you’re considering reorganizing your reg affairs department or outsourcing function. Maybe you’re launching your CRO’s services in Eastern Europe or building a new bioprocessing facility in a non-traditional region of the world. It’s important and could increase sales, capture additional market share, and bolster your professional accomplishments.

2. 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.

3. Adenovirus Production In Single-Use Xcellerex™ XDR-10 Bioreactor System 9/10/2018

   This application note describes the production of adenovirus in HEK293 cells cultured in HyClone™ CDM4HEK293 culture medium.

4. Biopharma’s Talent Crunch: How To Gain And Retain Skilled Labor 8/23/2018

   What strategies should your company consider for recruiting, training, and retaining qualified candidates in order to remain competitive in a burgeoning biopharma market?

5. 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. 

6. How Biogen Integrated PAT With End-To-End Supply Chain Transparency 10/2/2018

   To drive dependable critical process control requirements, Biogen explored novel strategies to increase process and raw material control and optimize communication of data throughout the supply chain.

7. An End-To-End, Semi-Continuous Process For mAb Production 9/22/2019

   See how the different unit operations in a laboratory-scale monoclonal antibody (mAb) process can be connected and integrated into a semi-continuous process.

8. Managing Risks To Time Critical Product Imports At Clinical Supply Depots 6/11/2019

   Global regulatory standards for clinical trials are, simply put, complex. In this case study, learn how one company worked with its partner to overcome the challenge of a protocol based in the US, an investigational medical product (IMP) approved in the EU, and varying QP (qualified person) rules from country to country, to conduct their clinical trial in Isreal.

9. 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.

10. Purifying Tagged Proteins Using ÄKTA Go Protein Purification System 2/3/2020

    ÄKTA go is a small and compact liquid chromatography system that allows researchers to perform routine protein purification with ease while allowing for efficient use of bench and cold cabinet space.