Innovation Update
A Boost for Protein Expression:
Invitrogen has launched its GIBCO®OptiCHO Protein Expression Kit - the first kit of its kind to provide cells banked under cGMP conditions, enabling biotherapeutics manufacturers to speed regulatory submissions and time to market. The cell line development kit will provide not only the cGMP parental cells but also the components and all the protocols needed to engineer and select producing clones in a completely serum-free system. Amongst other things, cGMP requirements for production cell lines derived from parental cells include source verification, testing, history, control over cell production documentation, and ability to demonstrate chain of custody for the cells from creation through use in biotherapeutic production. Costs for testing & project management to meet these GMP guidelines can range from $30K to $50K - a significant amount for research labs.
The real kicker in this story, however, is the potentially game changing move of providing a single-fee commercial license with no royalties. Taking into account that current procurement costs for a research or commercial use license have been reported to range from $7,000 to $50,000 per year for research use licenses, and up to $500,000 per year (plus royalties on the therapeutic product) for commercial use licenses, Invitrogen’s attempt at market penetration may have a big effect on the balance sheets of cash strapped start-ups. In addition to the cost savings on licenses, royalties, documentation, & regulatory activities the GIBCO kit may also reduce productivity problems. In order to improve biosafety & regulatory approval timeline, many researchers have been removing serum and products of animal origin from cell-culture media during production of therapeutic proteins from CHO cells & using plant hydrolysates as nutrients. The drawback of using plant hydrolysates is that they often contain undefined levels of nutrients and can result in lot-to-lot variation in fed-batch performance and purification inefficiency, which are disadvantages when consistent protein yields are required. To solve this problem, the new kit makes use of chemically defined feeds which apparently not only eliminates the variability associated with using plant hydrolysates, but could also improve the productivity of biopharmaceutical protein manufacture and help move therapeutic proteins into clinical trials more rapidly.
Efficient Eye-Screening:
Using a technology originally developed at the Department of Energy's Oak Ridge National Laboratory to understand semiconductor defects, people at risk of becoming blind can now be screened for eye diseases such as diabetic retinopathy and age-related macular degeneration. The technology involves taking pictures of the retina and relaying them back to a database for comparison. Comparison with thousands of images of known retinal diseases, will determine if the patient passes the screening or is in need of follow-up care.
Manufacturers of semiconductors have used this technology for over a decade, to rapidly scan hundreds of thousands of tiny semiconductors to learn quickly about problems in the manufacturing process. "Right now, with 21 million diabetics in the United States, we need to be screening 400,000 patients for diabetic eye disease every week. Less than half of these diabetics receive the recommended annual eye exam, which is absolutely essential to minimize serious eye complications and potential blindness." says Edward Chaum, who is leading the medical portion of the project. Utilizing an automated process of this kind has the potential to not only improve ophthalmic care in rural areas but also reduce the burden on outpatient clinics & primary care physician offices in urban centre’s. The goal is to have hundreds of cameras installed in the US and beyond, for early detection of disease in a cost effective manner.
