Author Archives: Cheryl Scott

Introduction: Cell-Line Engineering and Development at BPI West

Critical to the manufacturing of biotherapeutics is development of robust and stable cell lines that express high-quality products in large quantities. Chinese hamster ovary (CHO) cells are the “workhorse” expression host for manufacturing glycoprotein-based therapeutics — from antibodies to enzymes and hormones and beyond — making them the subject of most industry discussion regarding both cell-line development (CLD) and engineering. Most methods, technologies, and strategies apply regardless of the type of protein to be expressed or the type of cells…

May 2022: From the Editor

When we founded BPI 20 years ago, already there were murmurs about the “death of print” in the publishing industry. And it’s true that in the ensuing decades, many publications (especially newspapers) have gone fully digital to save money and stay in business. But in every survey we’ve run over the years, the majority of our readers always have preferred the print version of BPI. Our digital edition has increased in popularity steadily — probably as older generations slowly give…

April 2022: From the Editor

There’s a funny meme going round social media about the naivete of conspiracy theorists: “My gut is that most of them have never been project managers. Their optimism is adorable.” And the adage may be that “too many cooks spoil the broth,” but I think it’s more like “too many stakeholders can overcomplicate anything.” That can apply to small teams working on relatively simple projects (a group of editors working on a single BPI issue, for example) as much as…

eBook: Potency Bioassays — Development, Trending, Transfer, and Automation

Bioassay development is a complex process that must be undertaken with great rigor and attention to detail. Potency testing experts use a range of methods including cell-based and binding assays. Consistency and reliability of results over time are paramount. Well-developed and -characterized methods are the end result of much phase-appropriate development work that goes on in parallel with bioprocess and biotherapeutic product development. This eBook begins with BPI senior technical editor Cheryl Scott’s report from the Biopharmaceutical Emerging Best Practices…

Antibody-Derivative Biotherapeutics: Fragments and Fusions Define the Future

Monoclonal antibodies (MAbs) remain the dominant biopharmaceutical product class, but as biotechnologies have advanced in recent decades, developers have found ways to exploit their “magic-bullet” capabilities while putting aside their limitations. That has led to a new generation of antibody-related therapeutics created by cutting and pasting molecular domains. Researchers are mixing and matching functional moieties of antibodies and other molecules to create custom-designed proteins with powerful efficacy and tunable targeting. A simple search at Taylor & Francis Online (https://www.tandfonline.com), the…

eBook: Antibody–Drug Conjugates —
A New Generation of Approaches Is Changing the Game

Combining large proteins with linkers and cytotoxins, antibody–drug conjugates (ADCs) may be the most complex drug molecules in development today. Despite early promise and product approvals, a number of technical concerns arose during product and process development. Characterizing and ensuring consistency in the number of small molecules that attach to the antibody — as well as ensuring their proper attachment and biophysics — all present significant challenges to ADC developers. Solving early problems associated with product quality has introduced a…

Tris, a Critical Raw Material: Improving the Quality and Consistency of Supply

ANGUS Life Sciences is the world’s largest supplier of tromethamine buffers and the only manufacturer of the tris molecule based in the Western hemisphere. The company sells directly to biopharmaceutical customers and contract manufacturing organizations as well as to reprocessors who repackage the chemical or process it into different grades and derivatives. After recent expansions in both the United States and Germany, the company now boasts dual-source manufacturing capabilities for its highest-purity tris products and is confident about its ability…

eBook: Diagnostics — Developing Rapid and Accessible Testing Solutions

The COVID-19 pandemic has brought myriad economic disruptions, social complications, and public-health calamities to the world. They have understandably overshadowed the silver lining of boosting biomedical science and technology in the realms of infectious disease, oncology, and more. But alongside the much-publicized commercial debut of novel vaccine technologies have come promising advances in medical diagnostics. In this eBook, BPI’s senior technical editor brings together perspectives from industry, academia, and expert organizations to highlight some of the latest diagnostic methods and…

November/December 2021: From the Editor

One silver lining to the cloud of meeting only virtually has been our ability to “attend” some conferences to which we’ve not made it very often in the past. For example, I enjoyed tuning into the International Society of Pharmaceutical Engineers (ISPE) 30th Annual Aseptic Processing Conference, which was held virtually this past spring. It helped me plan for our September featured report, and it provided a good general update on the current state of biopharmaceutical formulation, fill and finish.…

Viral Safety of Viral Vectors:
Special Concerns Arise When the Virus Is the Product

As anyone who has focused on host-cell proteins as process contaminants can tell you, trying to purify a specific type of molecule from a large mixture of many similar molecules is like trying to find a few particular needles in a huge pile of varied needles. The same could be said for purifying viral vectors from cell culture fluids. When viruses are the products, unwanted viruses are contaminants that must be separated away — or better yet, prevented from being…