Dec 01, 2006
By BioPharm International Editors
Volume 19, Issue 12

Company Description

AppTec, a GMP/GLP contract manufacturing and testing company offers GLP/GMP-compliant contract testing, development, and cGMP manufacturing services for biopharmaceuticals, cellular therapeutics, medical devices, and also tissue-based products.

Products and Services

AppTec provides a fully integrated approach for biotherapeutic protein product development. At its 75,000-square-foot, state-of-the-art facility in Philadelphia, AppTec offers proven competencies that cover the full spectrum of development services for mammalian cell-culture-based biopharmaceuticals, including toxicology testing, cell banking, cell line characterization, process development, custom GMP manufacturing, lot release and stability testing, viral clearance validation, and final product formulation and fill.

Experienced professional and technical staffs provide cutting-edge science, in-depth regulatory expertise and quality assurance, with a commitment to customer service that delivers on flexibility and true customer-based solutions. A dedicated project manager oversees all aspects at all stages of a sponsor's project, serving as a single point of contact to streamline communication and ensure that project timelines and cost objectives are met. To facilitate sponsor interaction throughout the project, AppTec developed dedicated space for sponsors to work on-site during critical project phases, or as a "man-in-plant."

In addition to its services for biopharmaceuticals, AppTec offers unique GMP contract development and manufacturing services for cellular therapeutics, and the processing and assembly of tissue-based products. Comprehensive GLP and GMP-compliant testing services for cell- and tissue-based products are also available. For the medical device industry, a full range of testing services includes biocompatibility/toxicology, package testing, environmental monitoring, microbiology, and viral clearance.


AppTec has three FDA-registered facilities located in St. Paul, MN (corporate headquarters), Philadelphia, PA and Atlanta, GA. At its Philadelphia facility—the center for its biopharmaceutical services—AppTec maintains five bulk drug substance production suites designed for maximum flexibility, with a cell culture capacity ranging from 100 L to 2,500 L. Each suite comprises separate cell expansion, bioreactor, and downstream purification processing areas. Five cGMP cell-banking suites are available for cell banks ranging from 10 to 1,000 vials produced using a cell culture methods. A separate small-scale formulation and filling suite using barrier isolator technology and semi-automated fill approaches exists for traditional glass vial, stopper, and metal seal container closure systems.

2540 Executive Drive
St. Paul, MN 55120, USA







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