Expand your knowledge with unparalleled access to new, unpublished data and exclusive case studies from companies of all sizes and perspectives at the most comprehensive event for those directly involved with improving the speed, cost, and quality of developing and manufacturing biotherapeutics. This event will help you improve manufacturing and development efficiency, enhance process understanding and quality, advance cell culture and upstream processing, streamline recovery and purification, and optimize the quality and novelty of your next-generation biologic drug products. To…
Search Results for: antibody characterization
Bioreactor Design and Bioprocess Controls for Industrialized Cell Processing
It’s official: The “Age of Cell Therapy” has arrived. A robust pipeline of cell therapies, with increasing numbers of both early- and late-stage clinical trials as well as FDA-approved commercial products that have entered the market already, strongly indicates that the cell therapy industry is poised to emerge as a distinct healthcare sector (1). Renewed investor interest and recent activity among major pharmaceutical companies suggest that this industry will rapidly develop the capability and capacity to be a highly competitive,…
Vertical Integration of Disposables in Biopharmaceutical Drug Substance Manufacturing
Single-use (disposable) technologies are gaining significant traction in biopharmaceutical manufacturing due to reductions in capital investment for plant construction, lower requirements for cleaning and sterilization, and the advantages of eliminating cross-contamination during multiproduct manufacturing (1,2,3,4). In the early days of disposables, single-use (SU) systems were used only in specific unit operations (5, 6). Recently, however, options have become more widely available throughout drug-substance manufacturing (7,8,9,10). Companies now focus on selecting the right SU technology from an array of…
A Decade of Animal Cell Culture
Eukaryotic cells are fragile and finicky, requiring very specific culture conditions and nutrients to survive, grow, and be productive in an ex vivo environment. Even so, they have become vital to the biopharmaceutical industry’s ability to make complex biological products — overtaking yeast as a production system around 1990 and surpassing bacteria in the number of associated product approvals five years later (1). Since then, they have become even more useful, expanding their reach into the vaccine world. Mammalian cell…
A Decade of Formulation
Although no biopharmaceutical pills are yet on the horizon, formulation and delivery have advanced over the past 10 years. Formulators have new biophysical technologies and new product types (such as protein–drug conjugates) to work with. The most important issues haven’t changed much, though — from aggregation to stability, freezing to freeze-drying — although the FDA’s quality by design (QbD) initiative changes the strategies used to address them. Fragile proteins and other biologically sourced macromolecules need protection to achieve…
A Decade of Product Development
In 2004, the United States Food and Drug Administration (FDA) transferred regulation of many highly purified, “well-characterized†biopharmaceutical proteins from the Center for Biologics Evaluation and Research (CBER) to the Center for Drug Evaluation and Research (CDER), which until then had primarily regulated only synthetic, small-molecule drugs and chemical substances. The most novel/complex and the less-characterized biologics remained within CBER’s jurisdiction. This change complicated BPI’s mission somewhat. When the magazine was founded, we responded to questions from advertisers…
Fight Cancer with Nanotechnology
Imagine a diagnostic test that sifts through millions of molecules in one drop of a patient’s blood to detect the tell-tale protein signature of a cancer subtype. Envision a drug “ferry†that doesn’t release its cytotoxic contents until it slips inside cancer cells — or a molecule or small panel of proteins that can reveal within days whether a cancer treatment is working. Bioprocess Applications of Nanoparticles () Researchers have created nanosized particles and devices that are…
Strategies for Rapid Production of Therapeutic Proteins in Mammalian Cells
It is estimated that hundreds of new recombinant proteins and monoclonal antibodies (MAbs) enter preclinical and clinical development each year (1, 2). Concomitant global competition in biologics manufacturing has put immense pressure to shorten the time to market. Over the years, cells from various origins have been used for therapeutic protein production (2, 3,–5). One of the most economical choices is Escherichia coli, used to make proteins such as human insulin and growth hormone. But the bacteria have some serious…
Meeting Regulatory Challenges for Cell-Based Therapies
Many companies follow a general rule when assembling regulatory packages for presenting new biologics: Accentuate the aspects of your new biologic that mimic approved therapies. For companies working on cell-based therapies, however, that is a challenging task. The industry lacks established models, and the current European Medicines Agency (EMA) regulatory definition of a cell-based therapy is simply “an advanced therapy medicinal product†(ATMP) (see EMA guidance box). Regulations for cell therapies cannot always be compared directly with those…
Current Issues in Assuring Virological Safety of Biopharmaceuticals
The weakest link in the chain is also the strongest. It can break the chain.— Stanislaw Jerzy Lec, Polish writer, poet and satirist (1906–1966) Biologicals ushered in a new era for treating debilitating and life-threatening illnesses. According to a Pharmaceutical Research and Manufacturers of America (PhRMA) 2011 report, more than 900 biotech medicines and vaccines are in development that are targeting more than 100 diseases (1). Market researchers expect annual sales of biologics (now at about US$100 billion) to grow…