Outsourced Pharma White Papers

1. BioProcess Containers – Materials Of Construction
   4/12/2018

   This paper details some of the important characteristics of the plastic films used to manufacture BPCs, with a discussion on E&L and Thermo Fisher Scientific’s strategy for characterizing the extractables profiles of our BPC films.

2. 6 Myths About Biocatalysis Every Manufacturer Should Ignore
   4/12/2018

   By recognizing and dispelling the myths associated with biocatalysis, a manufacturer can reap the benefits of this valuable technology, providing a route to greener, safer chemistry that delivers a higher overall yield and reduced cost by virtue of the exceptional selectivity of enzymes.

3. Can Your Clinical Supply Chain Pass The Brexit Pressure Test?
   3/13/2018

   - Clinical trial sponsors and clinical supply vendors must fully consider all attributes of their supply chains to ensure continuity of supply post-Brexit. This whitepaper outlines many questions that sponsors and vendors alike should ask

4. Buffer Management Solutions For Large-Scale Bioprocessing
   2/1/2018

   How outsourcing and technologies such as in-line conditioning (IC) and in-line dilution (ILD) can help prevent resource constraints, save time, and reduce manufacturing footprint and overall cost in buffer preparation.

5. Scalable Strategies For Parenteral Dosage Form Selection
   12/29/2017

   Understand the strategies which can be employed at the different stages of development when choosing parenteral dosage forms.

    

6. Multiplexing: Managing Risk With Proven, Single-Use Solutions
   11/27/2017

   With many uncertainties when introducing a new drug to market, seeking manufacturing flexibility to accommodate diverse demands and production needs is key.

7. The Race to Phase III: A Cautionary Tale of Scalability
   10/30/2017

   Follow the paths of two companies as they learn how a science-led, risk-based development approach yields a more successful outcome in the long run.

8. Insights And Tips When Addressing Bioburden Challenges
   8/30/2017

   This white paper addresses the challenges associated with the bioburden control process involved in making mAbs or other biologicals, as well as the single-use solutions and improved ways of working that manufacturers can use to avoid microbial contamination.

9. Bioburden: Addressing Microbial Contamination In Downstream Bioprocessing
   8/30/2017

   A discussion on the risks related to bioburden downstream processing and ways to mitigate them. Topics covered include improvements in raw material, equipment design, and chromatography resin properties.

10. Manufacturing Process Scale-Up For Phase III
    8/15/2017

    The reality is that several manufacturability problems could be brewing that will rain down during Phase III and cause costly delays, no matter how skilled the product and process may be.