Biochromatography systems enable biopharmaceutical companies to accelerate scale-up of new drugs from process development, to clinical trial manufacturing through to production
Millipore offers what it says is the broadest range of scale-up systems for developing protein and bioengineered product separations enabling fast ramp-up of new drug candidates as well as compliance to 21 CFR Part 11.
K-Prime biochromatography systems enable biopharmaceutical companies to accelerate scale-up of new drugs from process development, to clinical trial manufacturing through to commercial production.
Leveraging the power of K-Prime system's common control platform v5 (CCP v5) operating system, biopharmaceutical companies now have the ability to control all of their separation processes from a single robust platform.
Powered by Ifix Software, it is capable of controlling and linking Millipore's chromatography and tangential flow filtration (TFF) solutions.
CCP v5 software provides access to tools for developing, monitoring, and controlling complex separation applications; generating comprehensive batch reports; and sharing information across a network.
A full-featured solution designed for today's ultra-pure separation needs, the batch reporting feature meets the technical requirements of FDA's 21 CFR Part 11 for electronic records and electronic signatures as well as other regulatory requirements.
Four sizes of advanced, scalable, pre-engineered K-Prime biochromatography systems are available to enable fast, easy and economical scale-up.
Validation efforts are significantly reduced due to the commonality of design and automation platform.
K-Prime 40-I small scale system is designed for developing precise purification recipes for proteins and bio-engineered products requiring flow rates from 20 to 500 mL/minute.
Then, K-Prime 40-II itermediate scale system then enables rapid transfer of separation recipes from development to pilot scale as well as clinical trial evaluations that require flow rates of between 0.1-3lpm.
K-Prime 40-III mderate scale system speeds up transfer of regulatory approval of new drug products, providing separation operations from development to intermediate-scale manufacturing that require flow rates of 1-10 litres/minute.
Finally, K-Prime 40-IV large scale system quickly and easily transfers separations from pilot scale clinical manufacturing up to large scale production processes requiring flow rates of 5-30litres/minute.
In addition to the pre-engineered solutions, Millipore says it has the capability to design custom engineered systems to meet unique processing and site requirements: Millipore engineers work closely with customers to ensure needs compliance.
Whether pre-engineered or customised, all systems undergo comprehensive qualification testing and are shipped with a comprehensive documentation package.
