mAbs Formulation
and Fill Finish
Products for Development and Manufacturing
Formulating, sterile filtering, and filling a drug product is complex but crucial. There are many excipient choices, filter options, and fill-finish technologies, each of which can have an impact on key attributes of the final dosage form including stability.
Formulation
Monoclonal antibodies (mAbs) can be formulated for subcutaneous or intravenous administration. Robust risk mitigation strategies during formulation are essential to ensure regulatory compliance and safety of the drug product for patients. Safe and effective formulation hinges on the reliable sourcing of high-quality excipients manufactured according to GMP (IPEC-PQG GMP Guide and/or EXCiPACT GMP Standard) and with specified low bioburden and endotoxin levels.
Successful mAbs formulation requires a range of excipients with different functionalities, including:
- Stabilizers: Crucial for minimizing the formation of aggregates, precipitates, and free drug to ensure mAb stability during formulation, storage, and administration.
- Viscosity reducing excipients: Essential for reducing the viscosity of the final formulation, enabling higher concentrated formulations, improving injectability, and reducing pain at the injection site, thereby enhancing therapeutic efficacy and patient compliance.
- pH adjusters and buffers, salts: Key for tailoring the formulation and administration medium composition based on the final formulation type (liquid or lyophilized), administration route, target pH, and stability of the mAb molecule.
- Cryoprotectants: Utilized in lyophilized formulations to stabilize mAbs and other biomolecules during the freeze-drying process and storage.
In addition, effective formulation depends on successful mixing of excipients and the active pharmaceutical ingredients to assure uniformity and consistency of the bulk drug product.
To help you be successful in your large molecule formulation, the following products are available for you:
- SAFC® Pharma Raw Materials and Excipients (buffers, salts, stabilizers, CIP solutions, viscosity reduction platform)
- Millipore® Single-Use Solutions (mixing, assemblies and storage systems, connectors)
- Millipore® Sampling Solution (offline system)
- Millipore® Services (single-use and filter validation, equipment installation, system qualification, system training, system services)
- BioReliance® Services (final product release testing, and stability testing services)
Related Categories
Our portfolio of pharmaceutical excipients offers everything you need for medicinal drug product.
Our Viscosity Reduction Platform enables subcutaneous formulation of highly concentrated proteins.
We offer low bioburden, endotoxin materials for biopharma formulation.
The Integritest® 5 automated test instrument enables non-destructive integrity testing to be performed inline or offline on filtration devices.
Mobius® single-use systems can be designed to include either single or redundant sterilizing filters.
Robust fluid management systems mitigate the risk of process contamination. By combining our portfolio of single-use and multi-use systems, we can support your process needs.
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