Compiled by Angela Godwin
Biotech facility finished
ROCKVILLE, Md. – MacroGenics, Inc. (www.macrogenics.com), a private, venture-backed biotechnology company that focuses on the development, manufacture, and commercialization of immunotherapeutics for autoimmune disorders, cancer, and infectious diseases, has announced the grand opening of its recently completed cGMP manufacturing facility located in Rockville, Maryland. The manufacturing facility houses two large Wave bioreactors that enable MacroGenics to produce monoclonal antibodies under current Good Manufacturing Practice (cGMP) standards in 4,500 square feet of cleanrooms. The new site also provides the company with 10,000 square feet of space for support laboratories and offices. The company plans to begin manufacturing for clinical trials here in the spring of 2006.
CDER states selection
ROCKVILLE, Md. – Gerald J. Dal Pan, M.D., M.H.S., has been selected by the FDA (www.fda.gov) as director of CDER’s Office of Drug Safety. In his new role, Dal Pan will lead the agency’s post-marketing drug safety program. He will work closely with stakeholders to develop and maintain international and national contacts with regulators; implement policies and initiatives related to adverse drug events, and represent FDA and CDER in scientific and regulatory matters related to drug safety and risk management. In addition to the appointment of the new Director of Drug Safety, as part of his annual State of CDER address to Center employees, CDER Director Steven Galson outlined a proposed Center reorganization to better align staff functions with CDER’s goals and FDA’s public health mission. The goals of the proposed reorganization include: positioning CDER to fully participate in the Critical Path Initiative and improve regulatory and drug development science; increasing the visibility of the sustained, multidisciplinary, cross-Center approach to drug safety; and centralizing risk communication efforts.
Conference caters to contamination concerns
ROLLING MEADOWS, Ill. – The Institute of Environmental Sciences and Technology (IEST; www.iest.org) will hold its 52nd Annual Technical Meeting and Exposition at the Hyatt Regency Phoenix in Phoenix, Arizona, May 7-10, 2006. With its theme of “New Beginnings,” the conference will focus on a new era of IEST with more educational courses, including the exciting field of nanotechnology, a scholarship program for full-time students, a tabletop exhibition, and a new technical format consisting of seminars/workshops. The event focuses on the concerns of professionals in the fields of contamination control, product reliability, and design, test, and evaluation. Several new sessions/workshops will be added to the schedule, including panel discussions about: the development of document MIL-STD-810G; Aging Air and Ground Vehicles; Time Waveform Replication; Certifying Laboratories to ISO 17025; and UV Weathering. Also, a case study on silicon-related contamination of garments will be presented, and a review of ISO 14644-4 Design, Construction, and Start-Up is scheduled.
Packaging plant planned
KUNSHAN, China – Chesapeake Corporation (Richmond, Va.; www.cskcorp.com) has begun construction on a pharmaceutical packaging plant near Shanghai that will supply paperboard cartons, labels and leaflets to domestic and multinational pharmaceutical customers and will feature the lastest technology and manufacturing equipment. The new 36,000-square-foot plant will be built adjacent to Chesapeake’s existing plastic packaging plant in Kunshan and is expected to be operational by mid-2006. The company’s existing plant manufactures bottles for the pharmaceutical industry and recently became the first foreign-owned packaging facility to receive the 100,000 grade certification for its cleanroom operation from the State Food & Drug Administration in China. Once the new plant begins operations, Chesapeake officials will seek several quality assurance certifications for the facility, primarily those pertinent to the pharmaceutical and healthcare market, including cGMP, PS 9000, and State Food & Drug Administration (China) certification.
Embarking on expansion
HACKENSACK, N.J. – Progenitor Cell Therapy, LLC (PCT; www.progenitorcelltherapy.com), a full-service cell therapy development and contract manufacturing company, has begun construction on the next expansion phase of its cGMP/cGTP cell therapy manufacturing facility in Mountain View, California. In this phase of expansion, approximately 3,000 square feet of Class 10,000 ISO Class 7) cleanroom and support areas will be constructed to support the increasing contract manufacturing needs of PCT’s existing clients, as well as its growing base of new clients. In a recent press release, Stewart Craig, PhD, PCT’s chief technology officer and vice president, said the company anticipates having the cleanrooms qualified for cGMP manufacturing operations in the early part of 2006. He added that the company is currently in the design phase for further cleanroom manufacturing expansion.