Author Archives: Cheryl Scott

Building Toward Antibody–Drug Conjugate Success

“We are witnessing one of the most significant paradigm changes in oncology drug development, with some new types of immunooncology compounds inducing unprecedented increases in survival in certain solid and liquid tumor indications.” —Jagath Reddy Junutula (Cellerant Therapeutics) and Hans-Peter Gerber (Pfizer) (1) An antibody–drug conjugate (ADC) for cancer treatment needs four things to succeed clinically: It needs to target the right antigen using the right antibody, with the most powerful cytotoxin attached by best linker option. These features combine…

Antibody Derivatives: Deconstructing MAbs for the Next Wave of Biotherapies

Although they make up the largest and most successful category of biopharmaceuticals so far, monoclonal antibodies (MAbs) suffer from certain disadvantages. Some companies are addressing those limitations by deconstructing MAb molecules to create new emergent therapeutics. These antibody derivatives include: antibody fusions and fragments, bispecifics, trifunctional antibodies, and more. This eBook combines market analysis from consultant David Orchard-Webb with technical discussion from BPI cofounder and senior technical editor Cheryl Scott. It also includes commentary from editorial advisor Michiel Ultee and…

April From the Editor

Our focus on regenerative medicine this month, with its inherent personalized approach, brings to my mind aspects of “the patient experience.” Last week at BPI West in Santa Clara, CA, I was intensely moved by the performance of lymphoma survivor Toby Peach (www.tobypeach.co.uk). Our KNect365 colleagues will be asking him back this fall for the BPI Conference in Boston, and I encourage you not to miss him if you’re there. Many of us will be touched by some form of…

Monoclonal Antibodies: Beyond the Platform in Manufacturing

The vast majority of monoclonal antibody (MAb) production processes are based on fed-batch Chinese hamster ovary (CHO) cell culture and protein A affinity column chromatography capture. Increasing cost-consciousness — among innovator companies as well as biosimilar makers — has many companies looking “beyond the platform” for less expensive alternatives that may provide better results. Here the BPI editors review some state-of-the-art alternatives in upstream and downstream MAb drug substance bioprocessing as well as drug-product manufacturing. The current “gold standard” platform…

Introduction: Drug Product Discussions

Quality by design (QbD), risk management, and new technologies are shaping biologics formulation work in the 21st century. We saw much evidence of this at the BioProcess International Conference and Exhibition in Boston last fall, where a wide range of talks filled the Drug Product, Fill–Finish, and Formulations track during the week after Labor Day. Dingjiang Liu (Regeneron) offered a high-level discussion from the BioPhorum Development Group (BPDG) on “An Intercompany Perspective on Biopharmaceutical Product Robustness Studies.” Such studies ensure…

Continuous Chromatography: Experts Weigh in on the Possibilities and the Reality

Discussions of continuous processing in the biopharmaceutical industry are an important part of current efforts toward intensifying bioproduction and bioprocessing. Biomanufacturers are looking at all components of their development and manufacturing processes for ways to reduce the size of their facilities, lower costs, and increase speed and flexibility of operations. Increasing options for and availability of single-use technologies have been major enablers of myriad attempts to improve efficiencies. Although the general consensus may still be that single-use components are more…

Manufacturing Insights: Interviews from BWB 2018 Highlight Perspectives on Streamlining Manufacturing Timelines

Addressing manufacturing and technologies strategies to accelerate market entry is one of BPI’s highlighted themes for 2019. In partnership with our conference colleagues in Informa’s KNect365 division, this already has been a shared theme, reflecting the general goals of the industry and related advice from its regulators. BPI’s summer 2018 preconference ebook included interviews by Dan Stanton (editor, BioProcess Insider) with speakers previewing their talks for the BPI Conference in Boston on 7 September 2018. Two of those conversations focused…

Aspects of Acceleration: Biomanufacturers Need Smart Strategies to Speed Products to Market

No matter what the industry, it’s widely accepted that slow-moving companies give their nimbler competitors an advantage, allowing them room to dominate the market even if their products are not superior. “Me-too” products and their sponsors often are seen as followers rather than leaders — even if they offer improvements over what is already available. Fast movers are flexible and adaptive to a dynamic business environment. They capitalize on opportunities and navigate risks and challenges by responding quickly to changes…

Partnerships in Immunotherapy for the Future of Cancer Treatment

Immunotherapy seeks to harness the power of our human immune system to fight disease. In this rapidly evolving field, collaboration among different stakeholders is essential to bringing new treatments to market. Patient advocacy groups, researchers, hospitals, manufacturers, and government entities all are working together to translate promising new research into life-saving products. Types of immunotherapy include monoclonal antibodies (MAbs) and antibody derivatives, checkpoint inhibitors (immune-modulating proteins), cancer vaccines, T-cell therapies, and cytokines — so the approach involves a range of…

Biopharmaceutical Characterization,
Part 1: Biological Assays —
A Conference Report

In late October 2018, KNect365 brought together more than 250 analytical specialists to discuss characterization of well-characterized biologics in Rockville, MD. Speakers from the US Food and Drug Administration joined experts from leading biopharmaceutical companies, service providers, and consultancies, including BPI editorial advisor Nadine Ritter (president and analytical advisor of Global Biotech Experts). She began the final day moderating a special town-hall session where audience members could pose their regulatory questions to a panel of FDA reviewers, and she ended…