CMC Essentials for Team Leaders in Biologics Product Development
Developed & Conducted by the Division of Pharmacy Professional Development, School of Pharmacy, University of Wisconsin-Madison.
This course covers practical CMC aspects for large molecule (biologic) development programs and associated regulatory filings. Presentations will cover key technical activities carried out in drug substance, drug product, analytical method development leading to the initial IND and subsequently to a BLA/CTD. Other important activities typically conducted by the CMC team covered include the preparation, testing, packaging, and labeling of clinical trial supplies and the associated elements of quality assurance and regulatory compliance. In addition, the course covers basic project planning for regulatory filings, including timing of events and interdependencies of the many tasks required to advance a candidate to Phase 1 and beyond. Filing documents are examined, section by section, with a description of the content of each section and the typical level of detail consistent with FDA guidance documents.
The overall objective of the course is to provide current and prospective CMC project leaders and others engaged in chemistry, formulation and manufacturing activities a sufficient depth of knowledge and management skill to immediately and positively impact their organization’s CMC development activities and regulatory filings, the key deliverables of the team. Concepts and lessons are equally applicable to all stages of drug candidate and life cycle management development programs. As noted in the course title, and per the requests by many past attendees in the CMC small molecule focused course, the focus of this course is large molecules.
This course is part of the Drug Product Development Certificate. It fulfills one elective. Take the course ‘as-is’ or as part of the certificate.
Developed & Conducted by the Division of Pharmacy Professional Development, School of Pharmacy, University of Wisconsin-Madison.
$875 Academic and non-profit (contact us for registration code)
$440 Graduate student (contact us for registration code)
Please contact us for group discounts.
This course is online and self-paced. You may register at any time and complete the curriculum at your own pace by December 31 2027.
Course Objectives
The overall objective of the course is to provide current and prospective CMC project leaders and others engaged in chemistry, formulation and manufacturing activities a sufficient depth of knowledge and management skill to immediately and positively impact their organization's CMC development activities and regulatory filings, the key deliverables of the team. Concepts and lessons are equally applicable to all stages of drug candidate and life cycle management development programs. As noted in the course title, and per the requests by many past attendees in the CMC small molecule focused course, the focus of this course is large molecules.
Upon completion of the course, the attendees should be able to describe:
The role of the CMC team and project manager in the broader context of the entire product development program
Project planning and timing of CMC-related events leading to regulatory filings
Practical approaches for addressing typical tasks carried out by the project team
Key large molecule drug substance, drug product, and analytical method development activities as they pertain to regulatory filings
Content of Drug Substance and Drug Product sections of regulatory filings and the level of detail recommended by relevant FDA guidance documents
Who Should Attend
Scientists, technical managers and directors who work in preclinical and clinical drug development as part of CMC teams, particularly those already managing or motivated to assume leadership responsibilities for large molecule, new biological entity (NBE), and accompanying life cycle management programs. Attendees include PhD graduates with typically 3+ years and MS graduates with 5+ years of experience in product development.
The scientists, managers and directors who would benefit from the course include those working in process chemistry, analytical chemistry, preformulation and formulation development – all as relates to large molecules. Other individuals who would be well-suited to attend this short course are those who have previously completed other core Applied Drug Development short courses: 1) Principles and Experimental Strategies in Physicochemical Characterization, Solubilization, and Solid Form Screening for Candidate Selection, and/or 2) Practical Strategies for Developing Preclinical and Phase 1 Oral Drug Formulations. This course integrates the most critical scientific elements presented in the above-mentioned courses into coherent project plans created and executed by optimally led CMC development teams.
Course Outline
Module 1
Differences: Small Molecules vs. Large Molecules (Biologics)
Speaker: Satish Singh, PhD, Vice President, Drug Product Development, Astria Therapeutics, Boston, MA
The speaker will compare and contrast key properties between small molecules and large molecules, aka Biologics, including Structure, Manufacture, Delivery Toxicology, and Immunogenicity.
Module 2
Biopharmaceutical Informatics: Learning to Discover Developable Biotherapeutics
Speaker: Sandeep Kumar, PhD, Former Distinguished Fellow, Head of Computational Protein Design and Modeling, Modema Therapeutics, Cambridge, MA
The speaker will cover current trends in industrialization of antibody-based biotherapeutics, the stages in antibody discovery, considerations of developability and pre-formulation during antibody discovery, pointing out opportunities for the use of computation at different stages of antibody discovery and early development. Finally, paradigm shifts related to discovering developable antibodies via computation, antibody developability in the age of mRNA delivery and developing screening assays.
Module 3
Biologics Drug Substance Development, Part 1, 2 & 3
Speaker: Adekunle Onadipe, PhD, Associate Research Fellow (Retired) Pfizer, Inc., Chesterfield, MO
This lecture discusses the critical stages of biopharmaceutical drug substance development, focusing on monoclonal antibodies. The lecture describes the steps involved in cell line construction, upstream (cell culture) bioprocess and downstream (purification) bioprocess development.
Module 4
CMC Biologics Development from a Regulatory Perspective
Speaker: Karen Sitney, PhD, Senior Director Regulatory Affairs Chemistry, Manufacturing and Controls (RA CMC), AbbVie, North Chicago, IL
The speaker will discuss points to consider during biologics drug development from a regulatory perspective, and how these aspects are presented in regulatory submissions. The primary focus will be antibody-based biotherapeutics but will also touch on advanced therapeutics.
Module 5
CMC Drug Product (Formulation) Development for Biologics
Speaker: Satish Singh, PhD
Dr. Singh will discuss the formulation development considerations that ultimately lead to a liquid or lyophilized dosage forms. Process development and control strategies will be discussed.
Module 6
Analytical Development for Biologics, Part 1 & 2
Speaker: Nesredin Mussa, PhD, President, Dynamica Biologics, San Francisco, CA
Assay development can be extensive and is critical to control drug product quality for biologics. The speaker will cover assays such as those for compendial testing, purity, impurity, bioassay development and identity testing. Dr. Mussa will cover the process analytical control strategies and setting specifications, and how those specifications may change over the drug product development process.
Module 7
Comparability: Overview and Assessment Strategy
Speaker: Satish Singh, PhD
The speaker will cover comparability for large molecules vs the approach used for small molecules (SUPAC). The various approaches for process comparability and analytical comparability are discussed leading to a phase appropriate comparability package with meaningful acceptance criteria.
Module 8
Comparability from a Regulatory Perspective with Specific Relevance to Biologics
Speaker: Karen Sitney, PhD
The speaker will discuss regulatory aspects of comparability, health authority expectations, and considerations for life cycle management, including some regulatory perspectives for Biosimilars
Module 9
Potency Testing for Biologics: Considerations for Rational Engineering of Robust Bioassays
Speaker: Jamison Grailer, PhD, Senior Research Scientist and R&D Group Leader, Promega Corp, Madison, WI
Following completion of this lecture, the student will understand the role of potency testing in biologics lot release. The speaker will also cover the act of identifying critical factors for cell-based bioassay performance and provide an understanding of analytical performance characteristics for bioassays.
