OP White Papers - random

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

   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 to avoid microbial contamination.

2. Digital Manufacturing Of Biologics
   2/19/2019

   In addition to an explanation of digital manufacturing, this paper covers how it can improve the productivity and robustness of existing processes and facilities. 

3. The Role Of Pharmaceutical Packaging Partners In Times Of Growth

   The expanding global pharmaceutical industry projects a 4%-6% annual growth and forecasts that it will reach a value of $1T by 2014. By Paul Dupont

4. Broaden Analysis Of Compound Factors For Predictive Solubility Solutions
   3/2/2017

   Developed by the FDA, the Biopharmaceutics Classification System helps companies when they file for bioequivalence of dosage forms based on in vitro dissolution testing.

5. Utilizing External Collaboration To Accelerate Vaccine Development
   11/2/2018

   Securing a partner to serve as an extension of Janssen’s Biotherapeutics Development API-Large Molecule team was essential to reduce both risk and the time needed for delivery of clinical supplies.

6. Scale-Up Of A Cell-Based Influenza Virus Production Process

   The white paper includes a brief discussion around modern vaccine processes, followed by a case study showing the scale-up of upstream and downstream processes for the production of a cell based live attenuated influenza virus using single-use ReadyToProcess technology.

7. In-House Versus Outsource: A Decision-Making Guide
   5/2/2018

   Biopharmaceutical executives must consider how outsourcing fits into their development and production strategy, as well as how to select the best CDMO partner for their business. Here’s a step-by-step guide to help make that decision.

8. Accelerate Flavivirus Vaccine Production With Modern Bioprocess Tools And Solutions
   6/11/2017

   This white paper gives an overview of modern tools and solutions, adding flexibility and speed to both upstream and downstream operations in flavivirus vaccine production.

9. Beyond Procurement: A Strategic Approach To Comparator Drug Sourcing
   4/25/2016

   The escalating volume and complexity of global clinical trials have been accompanied by a corresponding increase in the demand for comparator drugs.

10. What Clinical Teams Should Know About Changing Trial Logistics
    2/27/2019

    When it comes to clinical supplies, the journey is every bit as important as the destination and the price of failure is high. This paper discusses how supply logistics are changing and contains examples of how Fisher Clinical Services is deploying flexible solutions to ensure secure, efficient and cost-effective passage of clinical supplies.