2020

eBook: Cancer Vaccines ⁠— Innovation Fuels an Immunotherapy Renaissance

Despite early successes a decade ago, cancer vaccines designed to deliver peptides or proteins — or nucleic acids encoding those antigens — generally have fizzled out since then. As a result, cancer vaccine development and the field of immunotherapy lost some traction overall. But as freelance contributor Jim Kling describes in this eBook, new innovations in product design, testing, and manufacturing are fueling a renaissance in cancer vaccine development. From checkpoint inhibitors to neoantigens, immune regulators, and beyond, companies are…

eBook: Formulation, Fill, Finish ⁠— Biopharmaceutical Drug Products for a Modern Age

Biopharmaceutical drugs are increasing in sophistication, requiring technological advancements to solve related challenges. The contributors to this BPI eBook highlight drug-product formulation concerns and collaborative efforts toward solving the fill–finish conundrum. First, the BioPhorum’s Scott Ewan describes a holistic approach to container–closure integrity and the organization’s work toward developing and expanding upon that approach. Ewan explores how advancing analytical technologies, risk management, and quality by design (QbD) are changing the strategies related to container–closure integrity, which remains a significant aspect…

Application of Targeted Locus Amplification for Enhanced Apollo X CHO Clone Screening

Speed to market is an important consideration for the development of lifesaving therapies, including recombinant monoclonal antibodies. However, increased speed must be balanced with quality to enable quick and efficient delivery of biopharmaceuticals to patients. Important determinants of quality include the genomic location and integrity of the transgene sequence within a recombinant cell line. Traditional methods of genetic characterization can provide incomplete information and results can be difficult to interpret. However, next-generation sequencing (NGS) approaches such as Targeted Locus Amplification…

Finding Efficiencies to Accelerate Biopharmaceutical Development

An old engineering adage says that in any technical project, you can get speed and/or quality and/or cost-efficiency — but you never get to have all three. The idea is that emphasizing any one of those parameters necessarily deemphasizes one or both of the others. For most of the biopharmaceutical industry’s early years, companies operated on that assumption. Many organizations saw speed as the weakest link that could be more or less ignored; others had money to burn. The smartest…

The Upstream Perspective: Taking Efficiency Beyond Cell-Line Development

With 20 years of experience in the biopharmaceutical industry — at Genentech, Applied Biosystems, Cell Genesys, Cellerant Therapeutics, and Bayer — Yuval Shimoni has written frequently for BioProcess International on a number of production topics. Those have ranged from process improvements and bioreactor scale-down validation, to raw materials management, to addressing variability and virus contamination events. For this featured report, we discussed hardware and instrumentation, quality by design (QbD) and related approaches, and other strategies that can take expediting upstream…

The Downstream Perspective: Putting Product Knowledge to Work Using Technological Innovations

After over a quarter century in the industry — including downstream processing (DSP) and manufacturing directorships at Boehringer Ingelheim and leadership roles in technology development, quality, and manufacturing at Novasep — European consultant Margit Holzer is a recognized expert in downstream processing of biopharmaceutical products. Holding a doctorate in biotechnology from the University of Natural Resources and Applied Life Sciences in Austria, Holzer is familiar to BPI readers as both an author and conference participant (1, 2). And in May…

The Analytical Perspective: Turning Data Into Information Requires Teamwork

As head of bioanalytics at Sanofi, Claire Davies leads a team of >90 people involved in development, qualification, and transfer of methods to internal and external commercial quality control units; characterization, comparability, and developability of proteins and gene therapies; and analytical support for up- and downstream development, production, product release, and stability testing. She has served in a number of roles over 18 years with Sanofi, from chemistry, manufacturing, and controls (CMC) leadership of preclinical to commercial products (leading and…

Get to IND Faster: Accelerated and High-Performance Cell-Line Development

In April 2020, Samsung Biologics hosted a webinar with John Gill, the company’s director of cell-line development (CLD). He focused first on chemistry, manufacturing, and controls (CMC) activities needed for preparing an investigational new drug (IND) application. Then he introduced a fast timeline for managing CLD programs to accelerate client projects to success. CMC Activities Samsung Biologics is a fully integrated contract development and manufacturing organization (CDMO). Starting with a client’s gene of interest (GoI), Gill’s group tailors CLD to…

Biosimilars Pipeline and Market Trends

Most biopharmaceutical industry experts now consider biosimilars to be mainstream products, indicating that the field has progressed immensely over the past 10 years. Nevertheless, when comparing approvals and commercial offerings across the globe between 2013 and 2020, it becomes clear that some regions welcome these therapies more than others do. Western European biosimilars markets continue to be kind to these drugs’ production, distribution, and coverage; and companies headquartered in Asia and the Pacific Rim increasingly are getting involved in biosimilars…

From the Editor: June 2020

BPI’s June issue always precedes a break in our regular issue schedules in July and August. But summer does not afford us any leisure. This July, we again shall bring you an eBook of summaries from the BPI Theater at the Biotechnology Innovation Organization’s annual convention (this year from digital presentations, which will be available in full on the BPI site) along with our annual Industry Innovators issue. Summer eBook topics will be formulation, exosomes, biosimilars, and expression systems. BPI’s…