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Lpath, Inc. (San Diego, CA, www.lpath.com) and Laureate Pharma, Inc. (Princeton, NJ, www.laureatepharma.com) have entered into an agreement for Laureate to manufacture Lpath's recombinant humanized monoclonal antibody, "Sphingomab," against bioactive lipids.

Novexin (Cambridge, UK, www.novexin.com) has received an additional ?200,000 grant from the UK Department of Trade and Industry (DTI) to continue development of its carbohydrate polymers to enhance the solubility and stability of proteins in solution.

Cobra Biomanufacturing Plc (Keele, UK, www.cobrabio.com) has appointed Dr. John Lovelady as Director of Manufacturing Operations for the group.

The development of biotech drugs poses challenges that cross several disciplines.

FDA ordered Donor Referral Services (Raleigh, NC) and its owner, Philip Guyett, to immediately cease all manufacturing operations and to retain human cells, tissues, and cellular- and tissue-based products (HCT/Ps) after an inspection found serious deficiencies in its manufacturing practices, including those governing donor screening and record keeping.

Genelabs Technologies, Inc. (Redwood City, CA, www.genelabs.com) has appointed Peter R. Young, PhD, to the position of vice president, biology.

EduNeering (Princeton, NJ, www.eduneering.com) and the Food and Drug Administration (Washington, DC, www.fda.gov) have extended their existing Cooperative Research and Developing Agreement (CRADA), originally formed in 1999, for five more years.

The US Food and Drug Administration has approved MedImmune's (Gaithersburg, MD, www.medimmune.com) supplemental biologics license application to use reverse genetics technology to create new vaccine strains for their influenza vaccines, including the intranasal FluMist vaccine.

PRA International (Reston, VA, www.prainternational.com) has completed the acquisition of Pharma Bio-Research (Zuidlaren, The Netherlands), an early-phase clinical development and bioanalytical company.

The Associated Chambers of Commerce and Industry of India (Assocham, www.assocham.org) have called for the establishment of a National Biotechnology Development Fund and a National Nanotechnology Development Fund, with outlays of approximately US $1 billion (Rs. 4,800 crore) and US $2 billion (Rs. 9,600 crore) respectively.

Emisphere Technologies, Inc. (Tarrytown, NY, www.emisphere.com) has signed a multi-product research agreement with Roche (Basel, Switzerland, www.roche.com) to explore the use of Emisphere's eligen technology in feasibility studies for new oral formulations of Roche molecules.

The nanotechnology vision of tiny microrobots that could move inside the body carrying out complex surgical repairs has been touted incessantly until it has become a clich?.

Ray (Rui) Zhong has joined China Biopharmaceuticals Holdings, Inc. (CHBP)?(Beijing, China, www.cbioinc.com) as senior vice president, finance and business development.

Mark Goldberger has been named the first medical director for Emerging and Pandemic Threat Preparedness at the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration.

Plast-O-Matic Valves (Cedar Grove, NJ, www.plastomatic.com) offers a low-cost flow control valve in natural polypropylene, PVC, and other rugged thermoplastics to maintain a constant, pre-determined flow in a piping system.

Biotechnology and pharmaceutical companies seeking to train employees, or even to create their own "online university" can now partner with The Pharmaceutical Institute (PI, Raleigh, NC, www.pharmainstitute.com).

Envita Natural Centers of America (Scottsdale, AZ, www.behealthyamerica.com) received a warning letter from the FDA on June 14 that states that the firm's manufacturing process violates the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act.

Poniard Pharmaceuticals, Inc. (Seattle, WA, www.poniard.com) has appointed Alan B. Glassberg, MD, as its chief medical officer.

Biocon Ltd. (Bangalore, India, www.biocon.com) has signed a licensing agreement with Bayer Healthcare LLC (www.bayerhealth.com), a subsidiary of Bayer AG (Leverkusen, Germany) for exclusive rights for its branded recombinant human insulin, Insugen, in China.

Catherine Wachira has joined The US Pharmacopeia (USP, www.usp.org), as director of the Drug Quality and Information (DQI) program.

Buffett prefers to buy small, publicly traded companies with ample room for growth.

Northfield Laboratories Inc. (Evanston, IL, www.northfieldlabs.com) has agreed to purchase a building it previously leased in Mt. Prospect, IL, to house its first commercial manufacturing facility to produce PolyHeme, Northfield?s human hemoglobin-based oxygen carrier, used to treat urgent, large-volume blood loss in trauma and surgical settings.

BioFlo 310 Benchtop Fermentor; Chromatography Sorbents for Protein Purification

The Naval Health Research Center (NHRC); Nastech Pharmaceutical Company Inc.; Amylin Pharmaceuticals, Inc.; Metabolex Inc.; Ortho-McNeil Inc.

Schering-Plough (Kenilworth, NJ, www.sch-plough.com) will establish Schering-Plough Produtos Farmaceuticos Limitada in Sao Paulo, Brazil, to market its core products.

GTC Biotherapeutics Inc. (Framingham, MA, www.gtc-bio.com) has been awarded a $1 million payment from LEO Pharma A/S (Ballerup, Denmark, www.leo-pharma.dk) for receiving a positive opinion on a market authorization application for ATryn, from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency (EMEA).

Wayne T. Smith; Steven Niedelman; Diana Kolaitis; David Horowitz; Deborah M. Autor; Florence Houn, MD; Julie Beitz, MD

A symposium at the AAPS National Biotechnology Conference in Boston, June 19-22, 2006, addressed key concerns and new developments in manufacturing biologic products in a sterile environment.

"Clinical data is the gold standard" for setting manufacturing specifications, said Patrick Swann, PhD, acting deputy director of the Division of Monoclonal Antibodies at FDA, at a session on specification setting at the AAPS National Biotechnology Conference that was held June 19-21 in Boston.

Protein aggregation is a term that can include many types of aggregation, from rapidly reversible aggregation caused by non-covalent bonds to irreversible aggregation in the form of covalent oligomers.