AppTec - Testing and Manufacturing Services

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Lot Release and Raw Materials Testing

Whether the product is medical device, biologic, cell therapy, tissue or combination, GMP requirements dictate that certain testing be conducted to confirm safety and consistency in the incoming raw materials and outgoing product. AppTec‘s expertise, years of experience, and uniquely broad menu of services provides manufacturers with a “single-source solution” to support their GMP quality assurance programs.

TESTING PROGRAMS

Lot Release Testing

AppTec understands the critical need for timely lot release testing. For biologics, AppTec supports bulk harvest, bulk drug substance, and drug product testing. For medical devices, AppTec performs testing needed for final product lot release.

Raw Materials Testing

Periodic testing of incoming raw materials verifies their consistency and safety.

Vendor Qualification

Testing of vendor-supplied product helps ensure that materials are of consistent composition and quality.

Process Change Validation

Changes in the manufacturing process are validated to prove equivalency or comparable efficacy.

ASSAYS

AppTec offers a comprehensive menu of services, with the expertise to advise clients on testing options as well as to develop customized tests that meet special needs.

The following list demonstrates the broad range of assays available for lot release, raw materials testing, vendor qualification and/or process change validation. Some of these tests would be obviously applicable only for certain product types.

Bacteriostasis/Fungistasis (Sterility Validation)

SterilityEndotoxin Validation (I/E)

Endotoxin / LAL / BET

Rabbit Pyrogen

Cytotoxicity

Microbial IDs

Microbial Limit

Bioburden Recovery Validation

Bioburden

Virology

Molecular Biology

Mycoplasma

Hemocompatibility

Chemical / Physical and FTIR

Residuals (EO, DNA, water)

Product-Specific Analytical Assays

Cell-Based Potency Assays

Sterilization Cycle Studies and Validations

Radiation Dose Studies and Audit Programs

Osteoinductivity (in vitro and in vivo)

ADDITIONAL SERVICES

Additional services, including customized assays and testing for controlled environments, are available.