Since it was founded, IDEC has focused on establishing and maintaining a leadership position in cell culture techniques for antibody manufacturing. Cell culture provides a method for manufacturing clinical and commercial grade protein products by reproducible techniques at various scales, up to many kilograms of antibody.
IDEC’s manufacturing facility is based on the suspension of culture of mammalian cells in stainless steel vessels. Suspension culture fermentation provides greater flexibility and more rapid production of the large amounts of antibodies required for pivotal trials than bench-scale systems that were previously utilized by the Company,
Switching from Rituxan to ZEVALIN
A FDA and EMEA-approved biologics manufacturing facility, IDEC has applied for an expanded license to manufacture multiple products. At the end of 3rd quarter 1999, IDEC transferred all manufacturing of bulk Rituxan® (Rituximab) to Genentech, which has the capacity to handle current projected Rituxan requirements.
Meanwhile, IDEC anticipates using its available capacity for production of commercial and clinical supplies of its other development candidates and third party contract manufacturing. If approved by the FDA, IDEC will supply its own commercial requirements of the antibody for ZevalinTM (Ibritumomab Tiuxetan) by manufacturing and marketing the antibody in the U.S.
Contract Manufacturing Services
The Company can support a wide range of support services to meet the manufacturing needs of other companies. These include: quality assurance and control, engineering, regulatory affairs, legal services, validation services, process development and fill/finish (provided by third party).
IDEC possesses a Current Good Manufacturing Practices (cGMP) certification, which assures that drugs are produced according according to the FDA’s exacting standards. cGMP certfication guarantees that manufactured products are safe, pure, properly identified, possess correct strength and are of high quality. IDEC has a broad spectrum of quality control testing capabilites, ranging from protein assays and analytical chemistry to process validation, method development and validation and raw material testing. In addition, IDEC has the experienced staff and quality systems to meet downstream processing requirements.