Introduction to Biotechnology Analytical Methods

Why Should You Attend:

You should attend this webinar if:

1. You are a full-time compliance and quality auditor
2. you may be called upon to assist one or a team of auditors going into your own company’s or a contracted quality control lab for biotechnology analyses
3. you may be called upon to perform a department self-inspection
4. you may be a member of the biotechnology/biochemistry analytical laboratory supervision or management who will host future audits and regulatory inspections

This webinar will show how GMP compliance and good science intersect in this critical laboratory supporting biotechnology API and the resulting, finished pharmaceutical manufacturing. This session will shed light on the evidence normally requested during audits and inspections of biotechnology analytical labs. You will learn how an FDA auditor/inspector thinks and use that knowledge to help your microbiology laboratory and its equipment, documents, records, personnel, etc. become audit-friendly.

Areas Covered in the Seminar:

• Assays for Total Protein.
• Reverse Phase and Size Exclusion High Performance Liquid Chromatography.
• Ion Exchange High Performance Liquid Chromatography.
• Reducing and Non-Reducing Sodium Dodecyl Sulfate Polyacrylamide Gel Electrophoresis.
• Peptide Mapping.
• Isoelectric Focusing.
• Matrix-Assisted Laser Desorption Time-of-Flight (MALDITOF) Mass Spectrometry.
• Adventitious Agent Prevention, Clearance, and Testing.
• Mycoplasma Test.
• Alpha-Interferon Antiviral Bioassay.
• DNA Restriction Mapping.
• Enzyme-Linked ImmunoSorbent Assay (ELISA).
• Western Blotting.
• Polymerase Chain Reaction.

Who Will Benefit:

This webinar will provide auditing tools as well as useful compliance knowledge and ideas for continual improvement to the following individuals inside and outside the life sciences industries:

• Compliance and/or Quality Auditors
• Quality Control Microbiology Analysts, Supervisors, Managers, Directors
• Quality Assurance and Compliance Management
• Consultants
• Regulatory Inspectors/Investigators

Instructor Profile:

Bob Seltzer, has more than 25 years in R&D, Process Development, and Quality Assurance/Compliance in pharmaceuticals, medical devices, food, dietary supplements, and cosmetics industries. He is currently President and Principal Consultant of "Worldwide GMP Compliance Professional (WWGMPCP)," providing due diligence, quality and compliance, and supplier auditing, risk management, consulting, technical writing, and training in domestic or international pharmaceutical, medical device, food, dietary supplement, and/or cosmetic Good Manufacturing Practices and related regulations, guidances, standards, compendia/monographs. He holds an M.S., Biochemistry; B.S., Chemical Engineering; and B.A., Biochemistry, all from Rutgers, New Brunswick. He is an ASQ Certified Quality Auditor, Quality Engineer, Manager of Quality/Organizational Excellence, Biomedical Auditor, and holds certificate No. 1 in the Certified Pharmaceutical GMP Professional after having founded and championed that certification adopted by the American Society for Quality in 2008.

Topic Background:

The end-product of biotechnological manufacturing is a protein. Proteins are relatively large molecules (between 2 kDaltons and 800 kDaltons). Their functionality (measurable as activity) depends on an intact three-dimensional structure. Activity assays must complement protein concentration (quantity) assays to determine the purity and potency of the protein of interest during manufacturing purification processes. An inactivated or denatured protein is completely non-potent, regardless of its concentration/quantity.

The analytical methods associated with manufacturing a protein via recombinant DNA technology (i.e., using genetically-modified bacteria or fungi or mammalian cells) are (i) protein and nucleic acid biochemical quantitation and characterization tests as well as (ii) tests for adventitious (i.e., unintended contaminating) organisms such as viruses and mycoplasma.

The auditing skills called upon when assessing biotechnology analytical methods, laboratories, equipment, instruments, and personnel are distinct from the science that underlies biochemistry/biotechnology. In other words, the mindset, background/experience, and intuition of a biochemistry/biotechnology analyst are alone insufficient for performing effective audits of these laboratories and analyses. Instead, holistic GMP compliance knowledge and experience and properly comprehensive audit planning and organization are necessary and sufficient for fulfilling the regulatory inspectorate’s expectations of this highly important combination compliance-and-quality audit.

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