BIO From The Editor and Guest Columns

  1. Decentralized Cell Therapy Production In Practice 4/21/2021

    Distributing the manufacture of autologous cell therapies to clinical and hospital settings to minimize time, cost, and logistics challenges is a popular conversation in biopharma circles. While many discuss it, Dr. Helen Sabzevari’s upstart biopharma Precigen is doing it.

  2. Inside San Jose’s Uncommon Biotech Accelerator 4/21/2021

    San Jose BioCube takes a unique approach to the incubator/accelerator model, capitalizing on big demand for the space that emerging-to-midsize biotechs need to grow their businesses. As a result, the accelerator is growing, too. Learn more about what to look for in accelerator space, whether or not you're in the Bay area.

  3. An Analysis Of The Gene Therapy Viral Vector Landscape 4/21/2021

    Over the last five years, multiple gene therapies have been approved by regulatory agencies and a bolus of late-stage pipeline assets are approaching the market. However, as the first gene therapies began to post early wins, several challenges have emerged. This article discusses the landscape of the viral vector sector.

  4. Manufacturing Therapeutics In Hospitals: Re-envisioning The Bioprocessing Paradigm 4/19/2021

    Most hospital-based therapies are “patient ready,” pulled from inventory and used with minimal preparation. However, advanced therapy medicinal products (ATMPs) are changing how we think about how we deliver therapies. The success of these new and complex therapies requires partnership with those administering them, which is a new paradigm.

  5. 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 awards program that recognizes the year's best advances in clinical and translational research, and why that’s such an important structural element in the bridge between academia and industry. 

  6. 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. 

  7. 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.

  8. 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. 

  9. 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.

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

    Environmental monitoring (EM) trending is an essential component of the EM program 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 establishment of an efficient environmental monitoring program.