Biologics CMC Fundamentals: FAQ.

It connects the whole of biologics CMC in one story. You follow RA-101, a fictional monoclonal antibody, from the gene and cell line through upstream and downstream manufacturing, product quality and CQAs, analytics, specifications, formulation and drug product, stability, process validation, comparability, the CMC dossier and post-approval lifecycle.

Professionals and students building a foundation in biologics CMC: regulatory affairs, regulatory CMC, quality, analytical, manufacturing, development and project management, and graduates moving into biopharma. No advanced background is needed. It is also a useful refresher for anyone moving from small molecules to biologics.

A welcome section, 12 core sections and a conclusion: The Molecule; Cell Line and Upstream; Downstream and Viral Safety; Product Quality; Analytics; Specifications and Patient Safety; Formulation and Drug Product; Stability; Process to Commercial; Managing Change; Development and Dossier; Post-Approval Lifecycle; and a conclusion with the final competency check.

45 short video lectures of four minutes or less, with English subtitles and chapter markers; 13 quizzes with 63 questions; 4 applied RA-101 cases; 12 one-page quick references and a 5-page cheat sheet. An optional bonus pack adds 33 interview prep questions with model answer frameworks, 65 acronyms, 16 ICH guideline codes and a 148-term glossary.

About 5 hours in total, including about 3 hours of video. It is fully self-paced, on the web and in the TrainerCentral mobile app.

USD 99, or INR 6,999 in India, as a one-time payment with 365 days of access from the date you enrol. Participants of the Global Regulatory CMC Strategy for Biologics workshop receive complimentary access as pre-reading.

Yes. Lessons unlock in sequence so the RA-101 story builds step by step. A lesson counts as complete once you have worked through at least 80 percent of its video or reading.

Complete all lessons, including the final competency check (15 questions, pass mark 80 percent, up to 3 attempts) and the short course feedback. You then receive a RegAtrium certificate of completion and a digital badge with course code RGA-BCM-101, which can be checked on the certificate verification page.

Yes. It is the recommended pre-reading for Global Regulatory CMC Strategy for Biologics. It is not mandatory, but it helps anyone who is new to biologics or wants to refresh the fundamentals before the workshop.

No. RA-101 is a fictional antibody created for teaching, and the case data are illustrative. The course is for education only and is not regulatory, legal or professional advice.

The content is version 1.0, reviewed in November 2026, and refers to current ICH guidelines. Always check the latest regulations and guidance for your product and region.