February 12th 2025
Personalized medicine is a trend that continues to impact innovation and business decisions in the biopharma industry.
The evolution of therapeutic modalities drives the adoption of single-use technologies.
Disposables: Biopharmaceutical Disposables as a Disruptive Future Technology
June 1st 2007Today, most disposables are used for process development and clinical-scale manufacturing. Substantial growth in disposables usage may not occur until disposables are incorporated into the production of licensed products at commercial scale.
New Manufacturing Facilities Announced
May 23rd 2007Eden Biodesign (Liverpool, UK, www.edenbiodesign.com), SAFC (St. Louis, MO, www.sigmaaldrich.com/SAFC/Pharma), Midatech Group (Oxfordshire, OX, www.midatechgroup.com), Cellexus Systems (Cambridgeshire, UK, www.cellexusbiosystems.com), and BioConvergence LLC (Bloomington, IN, www.bioc.us) are sprucing up their product development and services with the construction of new manufacturing facilities.
Pandemic Preparedness Picks Up Pace with First Flu Vaccine Approval
April 22nd 2007The FDA's (Rockville, MD, www.fda.gov) first approval in the United States of a vaccine for humans against the H5N1 influenza virus marks an important step forward in protecting the public against a pandemic influenza outbreak.
Abbott Zeroes in on Puerto Rico for Biologics Manufacturing
April 22nd 2007Abbott (Abbott Park, IL, www.abbott.com) recently announced the official opening of its new biologics manufacturing facility in Puerto Rico to support the long-term supply of its leading biologic agent, HUMIRA (adalimumab), and other future biologics.
Singapore Burgeoning with New Biotech Facilities
April 22nd 2007Singapore's efforts to grow its biologics manufacturing sector received a significant boost on March 28, 2007, when the Singapore Economic Development Board (EDB) announced that Genentech, Inc. (San Francisco, CA, www.gene.com) has decided to establish a commercial-scale microbial-based biologics manufacturing facility in Singapore.
USP Seeks Participants for Glycan Analysis Study
March 22nd 2007The United States Pharmacopeia (USP, Rockville, MD, www.usp.org) and the UK's National Institute for Biological Standards and Control (NIBSC, Hertfordshire, UK, www.nibsc.ac.uk) are seeking participants in a study of analytical methods used by the industry to characterize and quantify oligosaccharides.
Sartorius AG and Stedim Biosystems Join Hands for Disposables
March 22nd 2007Sartorius AG (Goettingen, Germany, www.sartorius.com) has acquired a substantial stake in the biopharmaceutical supplier Stedim Biosystems S.A (Aubagne, France, www.stedim.com) and combined its biotechnology division with Stedim.
Downstream Processing: Platform Technology for Developing Purification Processes
March 1st 2007To shorten time to market for new therapeutic proteins, new and fast methods, such as high throughput screening, are needed to speed up downstream processing. The platform technology discussed in this article includes a structural approach that can be used as a general procedure to purify therapeutic proteins. The approach starts with ligand screening and selection-on-a-chip, with the Surface Enhanced Laser Desorption Ionization–Time of Flight (SELDI–TOF) mass spectrometer system. Next, resin screening and supplier selection are performed using robotics, followed by scouting studies under dynamic conditions to select the best resin. Finally, optimization studies of critical parameters are carried out with statistical design approaches (design of experiments). A few examples are presented to explain the platform approach for purification development in more detail.
CONTINUOUS PROCESSING: The Multicolumn Countercurrent Solvent Gradient Purification Process
February 2nd 2007This article presents the multicolumn countercurrent solvent gradient purification (MCSGP) process, which uses three chromatographic columns, and incorporates the principle of countercurrent operation and the possibility of using solvent gradients. A MCSGP prototype has been built using commercial chromatographic equipment. The application of this prototype for purifying a MAb from a clarified cell culture supernatant using only a commercial, preparative cation exchange resin shows that the MCSGP process can result in purities and yields comparable to those of purification using Protein A.
The HSV-1 and HVP-2 titers were determined by the inoculation of test solutions into Vero cell cultures and calculated using the Reed M?ench method.
Validating Extractable Substances from Components of Disposable Filtration Assemblies
November 9th 2006The many benefits of disposable technologies, such as significant savings in time, labor and capital, as well as ease of scalability and flexibility, have led to the growing trend of adopting disposable technologies in bioprocess manufacturing processes.