BIO From The Editor and Guest Columns

1. Biologics Clinical Research: The Year’s Best 4/16/2021

   Harry Selker, M.D. sits down with BioProcess Online for a candid discussion on the Clinical Research Forum’s work, its recognition of advances in clinical and translational research, and why that’s such an important structural element in the bridge between academia and industry. 

2. Making Sense Of Antibody Epitope Claims 4/16/2021

   Obtaining certain types of patent rights to antibodies has become increasingly challenging in the U.S. To comprehend this evolution, we must first take a careful look at what antibodies are, and then understand how they are claimed in a patent. 

3. Thermo Fisher To Acquire PPD 4/15/2021

   In an effort to create greater customer and shareholder value, Thermo Fisher Scientific has announced plans to acquire clinical research organization PPD for a cash purchase price of $17.4 billion. The purchase will also include the assumption of approximately $3.5 billion of net debt.

4. How Computational Biology Birthed A Biopharma 4/14/2021

   Computational biology services provider Compugen leveraged its proprietary technology to reposition itself as a therapeutic discovery and development company with a pipeline of eight solid tumor oncology candidates – six of them in the clinic. CEO Anat Cohen-Dayag, Ph.D. led the transition, and she shared the strategies employed during the pivot with BioProcess Online. 

5. How to Ensure Your Quality Culture Assures Data Integrity 4/14/2021

   One solution to ensuring data integrity is to automate the process, essentially removing the human element. But not all instances of data generation/capture can or should be automated. With humans – our team members – engaged in data generation/capture, the quality culture is a major pathway to assuring our data have integrity.

6. Tools And Best Practices For Trending Environmental Monitoring Data 4/11/2021

   Environmental monitoring (EM) trending is an essential component of the EM program and can be used to evaluate the overall health of the facility in terms of microbial control. Part 1 of this series looked at the regulations and guidelines around EM. This article discusses tools and best practices for using the trends to ensure that an efficient environmental monitoring program is established.

7. Your Drug Development Team Holds The Key To The Clinic 4/9/2021

   Amolyt Pharma founder and CEO Dr. Thierry Abribat credits his company’s fast clinical pace to the assemblance of a veteran drug development team that's learned from clinical and commercial successes. Here’s some of his advice for the leaders of new & emerging biopharmas.

8. Biopharma Cold Chain Logistics 101 4/9/2021

   Cold chain logistics can be complex and intricate. Maintaining the integrity of controlled-temperature products requires holistic consistency between design and development, manufacturing and packaging, qualification and validation, cold storage, transportation, and monitoring as the product moves from its point of origin to the end user.

9. Why Adjusted Risk Likelihood Should Displace The Risk Priority Number 4/7/2021

   While the RPN primarily represents a risk event’s severity, perhaps a more important attribute to focus on is the risk event’s likelihood of occurrence. In this provocative article, Mark Witcher, Ph.D., proposes an adjusted risk likelihood rating approach that emphasizes a risk event’s likelihood of occurrence.

10. An Introduction To Trending In Environmental Monitoring Programs 4/5/2021

    Trending environmental monitoring (EM) data is a regulatory requirement. However, it is useful in obtaining significant information about the facility. Trends can help determine if your facility is in a state of microbial control and relay the data to facility management in a meaningful format. In this two-part series, Crystal Booth of PSC Biotech looks first at the regulations and guidelines around EM.