2020

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

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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…

June 16, 2020

Biosimilars Pipeline and Market Trends

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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…

June 12, 2020

From the Editor: June 2020

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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…

June 11, 2020

The Green Imperative: Part One — Life-Cycle Assessment and Sustainability for Single-Use Technologies in the Biopharmaceutical Industry

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Much has changed since large-scale single-use biomanufacturing equipment was introduced some 15 years ago. Since then, these materials have become accepted and established in production and downstream bioprocessing. Concerns about the environmental impact of single-use (SU) biomanufacturing equipment have become more prevalent as our environmental awareness has increased and related concerns have become more urgent (1). For example, many recommendations and even laws have emerged regarding plastic convenience packaging and products (2, 3). People have become more sophisticated in appreciating…

June 11, 2020

Applications of Disposable Technologies for Upstream Bioprocessing

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Over the past 10 years, a number of developments in disposable (limited use) and single-use technologies (SUTs) have been made for different bioprocess operations. Until recent years, much of the industry’s process equipment was sterilized using thermal methods such as autoclaving. Most equipment was reusable and required cleaning and sterilization before use. Such processes required validation and expensive and time-consuming resources. Production facilities relied on hard-piped, inflexible equipment such as large stainless-steel bioreactors and holding tanks. However, advanced SUTs now…

June 11, 2020

Life-Science Lawsuits: Learning from the Ordeal

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Life-science companies often are cast into the role of the “canary in the coal mine†— the first parties to be targeted and hit by lawsuits. Such companies depend on discovery, trial and error, and ultimately efficacy. None of that is a sure bet. At the same time, life-science companies are raising funds constantly to finance their work. Investors and lenders seeing less-than-projected or even “expected†results might sue directors and officers for mismanagement, misrepresentation, or misleading financial statements. This…

June 11, 2020

Trends in COVID-19 Diagnostic Test Development

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The ongoing coronavirus disease 2019 (COVID-19) outbreak caused by a novel coronavirus (SARS-CoV-2) is posing a great threat to global public health and economies. Accurate and rapid detection of the SARS-CoV-2 virus and diagnosis of infection status will play a critical role in understanding the disease, selecting appropriate treatments, controlling the spread, and developing informed back-to-work policies. Currently, a review of ongoing efforts in the development of COVID-19 diagnostic tests is lacking. For this review, we collected data on more…

June 11, 2020

Viral-Vectored Gene Therapies: Harnessing Their Potential Through Scalable, Reproducible Manufacturing Processes

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We might not associate the jazz queen Ella Fitzgerald with 21st-century gene-based therapies, but the First Lady of Song was on to something back in 1939 when she sang “’T’Ain’t What You Do (It’s the Way That You Do It).†Although demonstrating the safety and efficacy of gene-based therapies in rigorous clinical trials is essential for gaining product approval from regulators, doing the bare minimum is insufficient. The way that such products are produced also matters. Manufacturing processes and protocols…

June 10, 2020

Anticipating Cell-Line Challenges to Drive CMC Readiness

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Development of a safe and high-quality Chinese hamster ovary (CHO) cell line is of paramount importance for the chemistry, manufacturing, and controls (CMC) portion of studies that support investigational new drug (IND) applications (1, 2). Desirable attributes of a CHO cell line include its ability to produce high titers of biotherapeutic proteins facilitate quick recoveries and selection processes maintain phenotypic and genetic stability throughout in-vitro aging of a culture. A CHO cell line also should be scalable to high-capacity culture…

June 10, 2020

Discover, Develop, Deliver

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Astrea Bioseparations is the only adsorbent supplier that can discover new affinity ligands designed to bind selectively to a molecule of interest or specific impurity, develop efficient purification adsorbents and downstream methods, and deliver industrial-scale adsorbents (up to 1,000-L batch sizes) as loose slurry or in good manufacturing practice (GMP)-ready columns. With over 30 years of experience in development of affinity products and design and manufacture of new custom adsorbents, Astrea Bioseparations is a world leader in its field. The…

June 10, 2020