Challenges and Innovation in Drug Product Formulation and Fill/Finish
The 2025 BioMAN Workshop will be conducted as a hybrid event, featuring discussions on:
Formulation and fill/finish (F/F/F) are critical manufacturing steps that ensure that biologic medicines reach the patients who need them. Drug product formulations are designed to ensure drug safety and efficacy by maintaining stability of critical quality attributes (CQAs). In fill/finish operations, the biologic is packaged in a delivery mode and dosage form consistent with its target product profile (TPP), which increasingly requires allowing patient self-administration or minimizing infusion regimen timing and duration. Manufacturers also aim to avoid losses of highly valuable drug product during F/F/F due to product defects or operational issues. F/F/F development can be challenging, especially for newer drug modalities or dosage forms which don’t have a long history and large knowledge base to draw from. Advances in technology platforms, modeling, and ML/AI-guided learning can help address these challenges.
This workshop will include case studies on challenges in formulation and fill/finish, including:
- Formulation development strategies for evolving biologic drug products modalities such as highly concentrated proteins, mAbs, and ADCs; mRNAs; cell and gene therapies; and exosomes
- Robust material selection and process design for handling autoinjectors and other final fill containers
- Managing visible and sub-visible particulate impurities through product and process design
- Technologies for automated visual inspection and rapid lot release
- Impact of drug product characteristics on supply chain requirements
If you are interested in joining the BioMAN membership, please contact Jessica McGrath or for any general questions, please reach out to Lola Atitebi.