In the eyes of regulatory authorities, the quality issues of biologics are definitely different from chemical drugs because of: (1) use of living source materials to produce the biologic, (2) increased complexity of biologic manufacturing processes and (3) increased complexity of the biologic molecules themselves. While chemical drugs can become generics, biologics products are best viewed as biosimilars, and not as bio-generics.
Biologics are highly susceptible to adventitious agent contamination – prions, viruses, mycoplasmas, and bacteria/fungi microbes. Risk control procedures – such as barriers to entry, testing to confirm absence, and inactivation/removal – are essential. Lessons can be learned from reported contaminations of biologic manufacturing processes. Compared to chemical drugs, biologics have a more complex process-related impurity safety profile, especially due to the living system-related impurities (e.g., host cell proteins, host cell DNA).
Extensive physicochemical characterization of protein and monoclonal antibody molecular structure, employing multiple, complementary, as well as orthogonal, state-of-the-art analytical methods is necessary, covering primary amino acid sequence changes (e.g., truncation, deamination, oxidation), post-translational modifications (e.g., glycosylation), and higher order structural changes (e.g., secondary folding, aggregation). Because of the molecular structural complexity of a biologic, including its many possible structural variants, functional activity assays are required that can discern which structures have what amount of potency. While bioassay functional activity assays (i.e., in vivo, in vitro) are required for measuring potency, surrogate (analytical) assays can be used if properly correlated to the bioassays. At times, an assay matrix may even be required. Many manufacturers underestimate the amount of resources and time needed to properly implement these functional activity assays.
This course will help the attendee to develop an effective QA/QC quality risk management strategy for biologics, addressing the quality challenges all the way from Phase 1 clinical studies through commercialization. Guidance from the FDA, EMA and ICH will be discussed. In addition, the differences in managing quality for chemical drugs vs biologics will be examined.
This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.
Who Should Attend
This three-day quality assurance (QA) and quality control (QC) training course is designed for management and professional staff involved in, or interested in quality assurance and quality control support for biologics and biopharmaceuticals. This course will be of particular interest to QA and QC personnel and management, Regulatory Affairs, Manufacturing, Process Development and Analytical Development staff, and anyone involved with the biologic and biopharmaceutical industry.
At the end of the course you will:
- Understand the critical importance and underlying principles for the QA/QC of biologics and biopharmaceuticals, and know how these principles differ from those for chemical-origin drug products
- Be able to develop a clinical-phase appropriate, cost-effective strategy to effectively manage the quality lifecycle through clinical development into commercialization of diverse biologic/biopharmaceutical manufacturing processes and products, including establishing effective inter-company quality agreements with outsourced contractors
- Have the tools and understanding necessary to adequately address biosafety (adventitious agents), potency (biological functioning bioassays) and impurity profile issues for biologic and biopharmaceutical products; and how to set appropriate and adequate product specifications and expiration dates
Frequently Asked Questions
Does the course cover both biologics and biopharmaceuticals in clinical development as well as market-approved?
The course covers the Quality Assurance (QA) and Quality Control (QC) requirements and expectations for biologics and biopharmaceuticals in clinical development (i.e., Phase 1 to Phase 3 studies) as well as those having market approval.
Does the course cover FDA and international concerns?
The course covers all aspects of QA and QC requirements and guidance for biologics and biopharmaceuticals from the FDA, European Medicine Agency (EMA), and International Conference on Harmonisation (ICH).
How does this course differ from the course CMC Regulatory Compliance for Biopharmaceuticals and Biologics™?
This course focuses on all aspects of keen interest to quality assurance and quality control, including control systems and setting of specifications and expiry dating for biologics and biopharmaceuticals. On the other hand, the CMC Regulatory Compliance course systematically covers all aspects of CMC regulatory compliance concerns, including areas of keen interest to regulatory affairs, manufacturing and development for biologics.