Wolfe Laboratories - GLP and GMP Services

>	CASE STUDY 1 Advancement of an Early Development Candidate to Phase IIb Trials
>	CASE STUDY 2 Development of a Parenteral Formulation of a Cytotoxic Natural Product
>	CASE STUDY 3 Oral Formulation Development for Proof-of-Concept Animal Toxicology Studies
>	CASE STUDY 4 cGMP Analytical Release Testing of a Cytotoxic Drug, as Well as Other Analytical and Bioanalytical Services
>	CASE STUDY 5 Parenteral Dosage Form Development of a Highly Insoluble Molecule

GLP and GMP Services

We recently expanded our service coverage into GLP- and GMP-compliant activities within the CMC and bioanalytical areas of operation, and are in the process of establishing GMP aseptic processing. We are now better positioned to serve client's needs as they progress into IND-enabling pre-clinical work and early clinical development studies.

GLP Services

Analytical method validation and stability testing
Dose confirmation
Bioanalytical method development and validation, and PK analysis
Manufacture and fill finish of test and control article

GMP Analytical Methods Installation, Transfer, Validation

As they become available, methods for raw materials will be installed and qualified. In parallel, validation of the analytical methods commences, which will then be applied to the stability and release testing of the GMP drug product.

Validation of a test method follows a general process. Once the method has been developed to test a specific attribute, it is qualified to ensure that it meets the appropriate specifications. In collaboration with the sponsor and the respective quality assurance groups, a validation protocol is written, the validation is executed, and a validation report is written. Upon approval of the validation, a test method protocol is then written, At this point, the validated method can be used.

GMP Release Testing

A test method protocol will be generated for all testing procedures used for release of the drug product. Wolfe Laboratories will generate the Certificate of Analysis (CoA) for the release of the drug product which will include all QC testing results obtained for the batch. A batch record will be generated for each batch, providing the results of the testing including all raw data.

GMP Long Term Stability

Wolfe Laboratories will test the long term stability of the drug substance and drug products under conservative, expected, and accelerated storage conditions from the time of manufacture over the appropriate timeframe, typically 24 or 36 months. The data obtained for the release of the GMP batch is used as a t₀ time point whenever possible. The stability tests, storage conditions, time points, and sample requirements will be defined in the stability protocol. A detailed technical report will be provided after each testing occasion, including all raw data acquired, and a summary report will be provided at the conclusion of the study.