Join us in Boston this September to celebrate the 10th Anniversary of IBC’s “BioProcess International™ Conference and Exhibition,” a milestone event providing the tools and knowledge you need to meet the demands of increasingly diverse product portfolios in an evolving biomanufacturing landscape. The inaugural BPI Conference in 2004 gave the industry’s an opportunity to exchange experiences and knowledge to optimize manufacturing processes and accelerate programs. Fast-forward 10 years, and this has become the industry meetingplace for product and process development…
2013
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…
Broadening the Baseline
When the editors of BPI asked us at BPSA to put together a content-rich article on single-use issues, we were happy to do so. Our challenge was how to bring in multiple viewpoints about the growing business of single-use that would be a “quick read” for the BPI audience. The answer: an expert colloquy. Represented here are several of the most qualified industry spokespersons in single-use — all are members of BPSA and speak as directors of the alliance. Their…
“Transformation By Infectionâ€
Every bioprocess begins with an expression system, and every expression system begins with DNA transfection. Derived from transformation and infection, the word paradoxically has come to be applied mainly to nonviral methods of genetically engineering cells; viral-vector–mediated DNA transfer is often called transduction. There are chemical, particulate, physical/mechanical, and viral means of getting new genetic material into a cell, and that DNA may take a number of different forms. Even the cloning method (pictured right) using a microscopic needle to…
Better Cells for Better Health
Since its inception 35 years ago, the biennial meeting of the European Society for Animal Cell Technology (ESACT) has built on a tradition of combining basic science and applications into industrial biotechnology to become the international reference event in its subject matter. Every other year, this gathering of academics and industry professionals features a famously exciting social program and an extensive vendor/supplier exhibition specific to animal cell technology. ESACT meetings are much-anticipated international venues for information exchange, inspiration, networking, and…
Purifying Common Light-Chain Bispecific Antibodies
A bispecific antibody can bind two different antigens. Immunoglobulin G (IgG) type antibodies have two binding sites with different variable regions. An IgG variable region is made up of a variable light-chain sequence (VL) and a variable heavy-chain sequence (VH). The light chains (LCs) of common LC antibodies are identical for both variable regions, leaving the heavy chain (HC) for generating different specificities. Thus, recombinant host cells for production of common LC bispecific antibodies carry genes for both HCs, with…
High-Throughput Chromatography Screenings for Modulating Charge-Related Isoform Patterns
Monoclonal antibodies (MAbs) are an important class of biopharmaceuticals and are widely used to treat a variety of diseases such as cardiovascular diseases, cancer, and blood disorders. Antibodies are very complex proteins that show a high degree of microheterogeneities, including charge-, hydrophobicity- and size-related variances (1). Such variants can arise during any stage in a manufacturing process or storage as a result of enzymatic or nonenzymatic processes (2). Particular antibody variants that may affect the in vitro and in vivo…
Artifacts of Virus Filter Validation
Virus filters are used in biomanufacturing to ensure the safety of biopharmaceutical drug products. As part of filter implementation, manufacturers are required to validate that the filtration process can indeed remove virus. Validations are typically performed at contract testing organizations (CTOs) that are “equipped for virological work and performed by staff with virological expertise in conjunction with production personnel involved in designing and preparing a scaled-down version of the purification process” (1). Virus removal capability of a filtration process is…
Bioengineered Ears: The Latest Advance
Physicians at Weill Cornell Medical College (WCMC) and biomedical engineers at Cornell University have succeeded in building living facsimiles of human ears. They believe that their bioengineering method will finally achieve the goal of providing normal-appearing new ears to children born with a congenital ear deformity. The researchers used three-dimensional (3D) printing and injectable gels made of living cells. Over a three-month period, the ears steadily grew cartilage to replace the collagen used in molding them. The study’s colead-author is…
The Role of Medical Affairs in Moving from R&D to Commercialization
Bringing a new pharmaceutical product to market is a unique process based on a number of requirements for supporting a product launch. For a research and development (R&D) company, launching a product into market may seem to be an issue for someone else to handle in the far-distant future and at a much later time. But even at laboratory or early development stages, biotechnology companies should understand the language of pharmaceutical companies and know how that industry operates. Doing so…