VIENNA, Austria - June 18, 2026
Regulatory scrutiny around monoclonal antibodies is becoming harder to separate from day-to-day CMC decision-making. For developers of mAbs, the pressure now sits across several fronts at once: ICH Q5E comparability, lifecycle change under ICH Q12, analytical procedure expectations linked to ICH Q14, and the familiar but still difficult task of connecting CQAs, CPPs and control strategy to real manufacturing data.
Against that background, Fleming will hold Monoclonal Antibodies – Quality & Regulatory Requirements on 13 & 14 October 2026 in Vienna, Austria & Online Live Stream.
The two-day training looks at the current regulatory landscape for mAbs through the practical work of development and submission planning. Topics include ICH Quality guidance updates, enhanced pharmaceutical development and QbD, process characterisation, qualification needs for BLA/MAA filings, and comparability protocols for process change. Not a small area, given how often manufacturing adjustments continue after clinical supply has already started.
Further sessions cover control strategy for clinical and commercial processes, analytical product profile development, method validation, analytical lifecycle management, stability, reference standards and product compliance. Process validation, CPV and technology transfer are also addressed, with attention to maintaining a state of control after transfer or scale-up.
The agenda also considers ADCs, bispecific antibodies and fusion proteins, including glycosylation, Fc/Fab-related effects, potency, high-concentration mAbs and hard-to-stabilise products. Case studies and real-world development challenges are included.
The course is led by Richard Francis, UK-based Principal Consultant, whose background includes CMC development, analytical characterisation, comparability, process performance qualification and regulatory submissions for biological products.
Code Media & Registration
Contact Karthik Naik
E: [email protected]
T: +421 257 272 100
W: fleming.events