April 2008

In the Facility Design Zone

As companies grow and expand their product offerings, it becomes necessary to consider manufacturing space. The decision to build is not made lightly, because CGMP manufacturing space comes at a steep price. Estimates range from $500 to $1,400 per ft2 to build new biopharmaceutical manufacturing space (1,2,3). As Jean-Francois Denault, Agnes Coquet, and Vincent Dodelet point out in their article in the February issue of BioProcess International, non-GMP biomanufacturing space comes at a much lower cost due to the lack…

High-Throughput Process Development

Increasing pipelines, shorter timelines, talent scarcity, reduced budgets — all these are issues faced by companies working in today’s biotechnology environment. The ultimate goal of a process development team is to stay off the “critical path” to drug approval. But how do they complete the necessary work to create a robust manufacturing process in light of such pressures? To increase the effectiveness of development, many companies are turning to high-throughput technologies within their development platforms. Such technologies promise that scientists…

In the Drug Delivery Zone

A rule of thumb in drug development states that the larger a therapeutic molecule is, the more trouble it will be to make, ship/store, and administer to patients. Biotherapeutics include proteins (such as antibodies), vaccines, some smaller peptides (such as hormones), DNA for gene-transfer therapies, cells and tissues, and to a lesser extent blood-fractionation products, allergenics, and RNA/oligonucleotides. Biomolecules are big and unwieldy, they’re produced in complex mixtures by biological processes, and they face numerous challenges in storage and within…

Current Status of Protein Quantification Technologies

With the help of rapid advancements in molecular biology and genetic engineering, a rising number of biotherapeutics are being developed and marketed. The quality and safety requirements for this class of active ingredients has steadily increased over the decades since Eli Lilly put forth the first insulin manufactured using genetically modified organisms in 1982. This has led to dynamic developments in protein analysis and proteomics intended to meet a growing demand for new technologies and sophisticated analytical techniques to characterize…

Sharing Is What It’s All About

Recently in Washington, DC, two conferences were held on the topics of cell and gene therapy. The California Separation Science Society (CASSS, www.casss.org) hosted a Well-Characterized Biological Products (WCBP) Chemicals, Materials, and Controls (CMC) strategy forum on “Current Practices for Assessing the Comparability and Stability of Gene Therapy Products,” while blocks away, Phacilitate hosted the 2008 Cell and Gene Therapy forum. At the WCBP CMC strategy forum, participants heard the US FDA–CBER perspective on the importance of comparability studies for…

In the Clinical Trials Zone

A new product takes a long and winding road from a laboratory to the patients it is designed to help. Many factors and organizations affect just how many months and dollars it will take to shepherd a new product from preclinical studies to market. Carefully documented, regulatory-compliant clinical trials are key to marketing approval. Clinical trials involve a choreographed network of regulatory agencies, sponsor companies, and clinical investigators. Myriad specialists in that network include those who produce and deliver an…

BioProcess International Analytical and Quality Summit

This event offers key strategic insights from industry leaders regarding assay qualification and validation optimization, improvement of the pace and quality of analytical results, and improvement of product quality through increased process understanding. It brings together three conference programs including The 4th Annual Analytical Method Validation, the 2nd Annual Biophysical Analysis for Bioprocessing, and IBC’s 5th Annual Process Quality Forum on Process Characterization and Control. Analytical Method Validation This event gives assay development and validation scientists a broad view of…

Cell Cultivation Process Transfer and Scale-Up

Discovery, development, and commercialization of novel biologics frequently involve collaboration between two or more companies. In the context of these business relationships, transfer of technology from one institution to another is a crucial step that needs to be executed flawlessly and rapidly. Follow-up activities usually include the development of productive, reliable, and scalable processes and are equally important because they are usually on the critical path to market. PRODUCT FOCUS: MONOCLONAL ANTIBODIESPROCESS FOCUS: TECHNOLOGY TRANSFER (PRODUCTION) AND ANALYTICAL METHODS DEVELOPMENTWHO…

Products, Services, and Literature

Process Monitoring Product: SciLog conductivity, pressure, and temperature (pictured) sensors Applications: In-line single-use purification monitoring Features: Sensors come with embedded memory with stored IDs, serial numbers, lot numbers, calibration, and any calibration offsets. Products are cleanable with NaOH or sterilizable by autoclaving, ethylene oxide, or gamma irradiation. Sensors and monitors document parameter changes during processing and send them to a printer, programmable logic controller (PLC), or to a spreadsheet on a personal computer. They come in a variety of sizes…

In the Information Technology Zone

Successfully driving your global business requires vigorous, secure information exchange within your facility, from site-to-site, and with your partners and contract service providers. Tools to capture data in real time support decision making and enable companies to manage volumes of historical data needed for regulatory submissions. Software is available for data mining, managing clinical trial networks, and assessing toxicology data (among many other things). Information technologies in the biotechnology industry facilitate development and delivery of new therapies and diagnostics, improvements…