Monoclonal Antibodies and Therapeutic Proteins: Designing GLP Compliant Nonclinical Programs to Meet FDA Expectations

During the development of monoclonal antibodies and therapeutic proteins, it is important to establish the safety of the products by animal testing before proceeding with clinical trials that involve humans. Animals will also be employed to determine early estimates of pharmacokinetic parameters and the effective dose. These studies must be conducted using the Good Laboratory Practice (GLP) standards and regulations that are described in 21 CFR 58. This presentation will cover the GLP requirements for animal studies, and the methods that laboratories employ to comply with the regulations.

Areas Covered in the seminar:

• Discussion of the regulations that apply to laboratory studies using animals to demonstrate safety.
• Laboratory organization requirements based on 21 CFR 58.
• Preparing the study protocol.
• Physical organization of the laboratory and requirements for animal handling.
• Activities of the study director.
• Activities of the quality assurance unit.
• Preparing the final study report.
• Institutional Animal Care and Use Committee.

Who will benefit:

This webinar will be directed at personnel who must conduct or review the performance of non-clinical laboratory studies related to safety. GLP studies apply to animal studies that are required in all regulated areas. The employees who will benefit include:

• Test facility employees who must conduct non-clinical studies
• Supervisors and auditors who must review non-clinical laboratory studies
• Regulatory personnel who must prepare submissions based on non-clinical laboratory studies
• QA and QC personnel who must deal with contract testing laboratories that perform non-clinical studies
• Regulatory affairs personnel dealing with early stage products
• Consultants

Instructor Profile:

Steven S. Kuwahara, Ph.D. is the founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. Steve has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories. He has performed audits of contract testing laboratories and performed evaluations of R & D laboratories and GLP testing laboratories.

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