News

Posted On: 09/23/2005

Althea Offers cGMP Lyophilization Services

PharmaManufacturing.com

Althea Technologies, Inc., announced Sept. 20 that it now offers current Good Manufacturing Practices (cGMP)-compliant lyophilization services as part its expanded array of contract manufacturing solutions. Lyophilization cycle development or clinical lot processing according to already developed parameters complement the existing aseptic vial and syringe filling services provided by Althea. Lyophilization and aseptic fill / finish services are conducted in cGMP manufacturing suites within Althea's 30,000-square-foot facility in San Diego, Calif.

Lyophilization (freeze-drying) is a process particularly useful for biological materials such as proteins and vaccines to enhance stability for long term storage or distribution. For high-value active pharmaceutical ingredients (API), lyophilization makes refrigerated storage unnecessary for normally heat-sensitive materials. In addition to supporting lyophilization of bulk and vialed clinical product, Althea offers the option of custom cycle development or selecting from standard cycles applicable to a range of products. Different packaging formats are offered as well as backfilling of vials with inert gasses such as nitrogen or argon. Althea's fill and finish capabilities include vial and syringe filling on fully-automated or semi-automated lines within class 100 (ISO 5) areas.

Rick Hancock, Althea's Senior Vice President of Operations, stated, "Our introduction of this service is a direct response to the requests of our aseptic fill / finish clients that rely on lyophilization to stabilize their products, prolong stability, and enable adequate distribution and storage of these pharmaceutical products. Many of these clients are targeting significant public health indications where storage and delivery of stable vaccine or pharmaceutical products is a critical manufacturing issue which can only be addressed through lyophilization."

Co-President and Co-CEO of Althea, Dr. Magda Marquet, added, "We are delighted to expand the suite of services we provide for bulk and finished pharmaceutical products, our fastest growing segment, to facilitate rapid clinical application of these innovative products. This service is also a wonderful complement to our recombinant protein and DNA vaccine manufacturing capabilities. Since a lyophilized form of these products may be beneficial, there are considerable time-savings in building lyophilization cycle development at the early stages of clinical manufacturing."

For more information, visit www.altheatech.com.