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.
Ensure a Successful Formulation and Fill Finish
The formulation process presents a range of challenges including the need to reliably source high purity excipients that are low in bioburden and endotoxins, maintain protein stability, and manage the viscosity of highly concentrated protein therapeutics.
Our extensive SAFC® portfolio for formulation, sterile filtration, and fill finish meets the requirements of high-risk liquid applications with low endotoxin and bioburden levels to ensure high quality while simplifying the complexity of supplier qualification and accelerating your workflows.
Final filtration and fill finish requires sterility and efficiency to ensure no volume loss and enable flexibility to process multiple products. Single-use fill finish assemblies offer the flexibility and productivity needed to respond to the demands of manufacturing a variety of drug products and fill volumes.
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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.
Related Resources
- Low NPI Sucrose for Biopharmaceutical Formulations
Read about a purification process resulting in low-NPI sucrose to achieve more stable protein formulations.
- Addressing Viscosity Challenges for Subcutaneous Injections
It was found that in contrast to single excipients, an amino acid and an anionic excipient can be more efficient at reducing viscosity when used in combination than when either is used alone, even at higher concentrations.
- White Paper: The Viscosity Reduction Platform: Viscosity-Reducing Excipients for Protein Formulation
Read about the effect of protein viscosity on injection force and the platform’s ability to balance viscosity reduction with protein stability.
- Formulation Product Finder
Quickly sort our excipients and API portfolio by dosage form, application, and many other parameters.
- Risk Mitigation Tool
Get guidance through the challenges and quality requirements of your bio-manufacturing process.
- Brochure: Millipak® Final Fill Filters Reduce Contamination Risks and Simplify Filtration System Design and Operation
This tech note summarizes the results of microbial challenge studies that confirm the aseptic multipurpose port (AMPP) prevents microbial contamination entering the flow path.
- Use of Stabilizers and Surfactants to Prevent Protein Aggregation
This article outlines critical factors in long-term stability of proteins, and manufacturing conditions and drug product handling.
- Brochure: Mobius® Single-Use Final Fill Solutions
The Mobius® single-use final fill offering allows end users to design robust, easy-to-use assemblies that ensure product quality and patient safety. We have a comprehensive library of single-use assembly components which includes filters, tubing connectors, needles and pumps.
- Tech Note: Improved Product Recovery Using Blow-Down and Millipak® Final Fill Filters
The objective of this study was to compare hold-up volumes of sterilizing-grade pleated membrane filters with those of Millipak® Final Fill stacked disc filters following filter drain by gravity and air blow-down.
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