Business

Cellular Communications

Like spectroscopy, as discussed in BPI Lab last month (1), cell signaling is not a laboratory technique but rather an area of scientific study. The environment of living cells — whether prokaryotic or eukaryotic, in vitro or in vivo — comprises not only water, nutrients, waste products, and metabolites, but also molecules released by other cells in response to intracellular events such as microbial infection and disease state or environmental factors such as temperature, osmolality, and pH. Receptor proteins on…

Emerging Challenges to Protein A

Protein A affinity chromatography has been a target for replacement since its commercial debut, mainly because of its high acquisition cost. The technique became established despite the cost because it was born into an industrial culture that favored speed to market over manufacturing economy (1). Vendors have since strengthened protein A’s position with incremental but worthy improvements such as higher capacity, lower ligand leaching, and modest tolerance of NaOH. Collateral improvements in polishing technologies, such as the high throughput and…

Spray-Dry Manufacture of Vaccine Formulations

Development of vaccines and immunotherapeutics has expanded rapidly due to technological advances in the fields of molecular biology and bioprocess engineering, as well as a smoothing of management and material logistics worldwide. Expression platforms and novel cell lines have enabled creation of increasingly complex vaccines. The advancement of vaccine formulation development is also capitalizing on new advances in manufacturing that use model-based methodologies gleaned from physiochemical principles, process analytical tools, and systematic approaches to problem solving. Herein we highlight recent…

An Industry–Academia Partnership

GE Healthcare Life Sciences recently launched a joint program with Osaka University to support future growth of the biopharmaceutical sector in Japan. Together, they offer students access to GE Healthcare’s expertise in training and technologies for bioprocess research and manufacturing. The program is funded by Osaka University as part of its “Interdisciplinary Program for Biomedical Sciences” (IPBS), a government-funded commitment to graduate education. The goal of IPBS is to educate young scientists to undertake global-scale collaborations to develop effective treatments…

Protein A

The number of blockbuster monoclonal antibody (MAb) drugs continues to grow. In 2008, MAbs generated revenues in excess of US$15 billion (1), making them the highest-earning category of all biotherapeutics. The world MAb market will reach $62.3 billion in 2015, with next-generation therapeutic antibody revenues reaching $2.3 billion in 2015 according to Visiongain reports published in September and November 2011 (2, 3). Biosimilar antibodies will also begin to enter established markets as regulatory authorities clear approval pathways for them. Most…

Moving Forward with a Gene Therapy for Damaged Hearts

A cocktail of three specific genes can reprogram cells in the scars caused by heart attacks into functioning muscle cells. Adding a gene that stimulates the growth of blood vessels enhances that effect, say researchers from Weill Cornell Medical College, Baylor College of Medicine, and Stony Brook University Medical Center in a report that appears online in the Journal of the American Heart Association (1). “The idea of reprogramming scar tissue in the heart into functioning heart muscle was exciting,”…

An Analysis of the US Biosimilars Development Pipeline and Likely Market Evolution

No consensus concerning biosimilar-related terminology and definitions has yet been achieved (1,2,3). Biosimilars may be defined as biopharmaceuticals slated for generic-drug–like, abbreviated, comparisons-based approvals through a formal biosimilar approval pathway in the United States, European Union, and/or other highly regulated and developed countries based on a demonstration of substantial (bio)similarity to a reference product. As required in the United States, biosimilar active agents (those involving recombinant proteins) must be identical in primary sequence with their reference products. Analytical and comparative…

In Vitro Functional Testing Methods for Monoclonal Antibody Biosimilars

The pressure to contain rising healthcare costs — combined with the number of innovator biologic drugs coming off patent (30 licensed biological drugs by 2015) — offers huge opportunities for developers of biosimilar products. In 2011, the global market size of the biosimilars industry was around US$2.5 billion. Global demand for such products — and monoclonal antibody (MAb) biosimilars, specifically — is estimated to grow at 8–17% from 2012 to 2016 (1). The advent of biosimilars should bring more affordable…

Concerns, Collaboration, and Capacity

The BPI Theater is a 50-seat venue that for seven years has been located at the heart of the BioProcess Zone on the exhibition floor of the BIO International Convention. There, BPI provides attendees with four days of live presentations focusing on the latest scientific advances and business trends in biotherapeutic development and manufacturing. On Monday afternoon, 22 April 2013, Patricia Seymour of BioProcess Technology Consultants (BPTC) moderated a roundtable discussion on biosimilar development in the BPI Theater at BIO…

Biologics Have a Robust Pipeline

Earlier this year, the Pharmaceutical Research and Manufacturers of America (PhRMA) released a report titled 2013 Report: Medicines in Development – Biologics. It lists 907 biologics currently in development at “America’s biopharmaceutical research companies.” The list includes biologics targeting more than 100 diseases that either are currently in human clinical trials or are under review by the US Food and Drug Administration (FDA). Of those 907 product candidates, the most common types are monoclonal antibodies (MAbs, 338), vaccines (250), and…