Biomanufacturing

Catalent Pharma Solutions has cGMP facilities for mammalian cell culture production in Middleton, Wisconsin. The facility employs experts in the fields of molecular biology, cell line development, biopharmaceutical manufacturing, protein biochemistry, and quality systems.

Process development and scale up

Whether using a Catalent Pharma Solutions GPEx® technology-based cell line or a client-derived cell line, we can design a program and process that can be easily transferred to a production plant. Elements of a program would include media optimization, cell culture processes parameters, cell line stability studies, bench bioreactor studies and pilot plant bioreactor runs.

Process development

Catalent has developed and optimized processes for growing GPEx technology cell lines in serum-free media. Our team has developed scaleable processes for a number of different proteins within several different classes, including monoclonal antibodies. Our process development studies aim to ensure the maximum production and yield of the target protein.

Quality systems

Our quality systems are designed to match facility compliance with high quality documentation practices...all cGMP compliant.

Project management

All operations from cell line development through production of preclinical and/or clinical (Phase I/II) API are performed in a single facility with a dedicated project manager. When you partner with us, you and your staff have direct access to our scientists. Through on-site visits and frequent direct communication with our project leaders, you’re always in the loop and up to date about your project.

Beyond problem solving, we take a more consultative, strategic approach to biopharmaceutical development. Our experience and proven systems streamline product development activities, decreasing development time and costs while improving the chances of product success. Ultimately, we optimize your speed to clinic, while maintaining the highest standards of quality throughout the process.

cGMP Biomanufacturing services:

Cell culture
Non-cGMP production in flask cultures, Wave bioreactors (10-100L), and stirred tank bioreactors (2L-100L) and Phase I/II cGMP production at the 200L scale, all supported by Catalent biopharmaceutical capabilities.

• Smaller quantities of protein and scale-up/process development for Phase I clinical material in shaker/T-flasks, spinner flasks, Wave systems, and/or stirred tank bioreactors
• cGMP manufacturing of Phase I / Phase II material in product-dedicated suites using stirred tank bioreactors

Purification
The Catalent purification team has extensive experience in developing robust purification processes for a wide range of proteins.

• Project team evaluates appropriate chromatography procedures to maximize yield
• Extensive experience in monoclonal antibody projects
• Extensive experience with chromatography systems, including affinity, ion exchange, hydrophobic interaction
• Experienced in applying viral clearance and inactivation steps such as low-PH holds and viral filters

For capabilities that meet your needs, and outcomes that exceed your expectations, call Catalent today. For more information, please fill out our contact us form or call a member of our sales staff at +1 866.720.3148.