Chesapeake Biological Laboratories, Inc. (CBL) - CROs

Analytical Methods
Analytical methods are used in a GMP environment to ensure the identity, purity, quality and strength of each finished drug product. At a contract fill and finish facility, it is common practice to accept a method dossier from the client, perform, and validate the methods. Full analytical validation is available from CBL and includes specificity, linearity, precision, range, limits of quantitation and detection, and robustness. CBL willingly embraces assistance from the client as may be necessary in the transfer of new and more complex methods and can either send a technician to the client site, entertain a client scientist, or both. The laboratory is fully automated and includes its own Part 11 compliant computer network for secure handling of data. Testing can be performed under three pharmacopoeias, USP/NF, EP, and JP. FDA cGMP regulations are always followed and ICH guidelines are used wherever applicable and on request. Standard analytical techniques include HPLC, LC, RI, GC, Karl Fischer, IR, UV, and TLC. A multitude of less common methods is also employed. Overall, several hundred testing methods are used and have been validated.
Clinical Supply Production
Materials for clinical supplies are taken seriously. CBL is capable of making small lots (but not hand fills) of high value product with extremely low line losses. These projects are entertained as possible for valued customers with the intent to develop commercial applications. All filling, including clinical supply materials, are performed under completely validated cGMP conditions.
Commercial Production
Capacity for commercial products is expanding within a controlled program. Aseptic filling of small volume parenterals (SVPs) is accomplished in one of three class 100 cleanrooms. Vials can be filled on either a Bosch 8 head filler with automatic check weighing or a two head Chase Logeman filler. Additionally CBL can fill pre-sterilized syringes on either an Innova two head filler using mechanical plunger insertion or a Cazzoli 5 head filler utilizing vacuum stoppering. Vial filling is currently available for vial sizes from 3cc to 100 cc and for both liquids and suspensions. Filling speeds range from about 16 per minute for the largest sizes to about 300 per minute for the smallest sizes. Typical liquid fill lot sizes are 20,000 to 100,000 units. Limited syringe capacity is also available at about 100 units per minute and for lots of no more than about 25,000 units. Lyophilization is performed in a 240 ft 2 lyophilizer that is fully steam sterilized.
Lyophilization
Products that require lyophilization are filled, partially stoppered, and loaded into the pre-chilled lyophilizer throughout the filling period. For commercial lots, a high speed filling machine is used to assure the minimum filling time and minimize product exposure to room temperature conditions. The lyophilizer, with external condensers, has temperature control to as low as ?65 degrees C and vacuum control between 50 and 1000 millitorr. A full load in the largest lyophilizer consists of 120 one foot by two foot trays.
Contact:
1111 S. Paca Street
Baltimore, MD 21230
Phone: (410) 843-5000
Fax: (410) 843-4414
Toll-Free: (800) 441-4225