Biological Process development & Scale up
Biologics is in our DNA and we are actively involved in Biological research and development, we can cater for the entire product lifecycle of your drug substances and products, We proudly drive down the costs of biologics to facilitate affordable healthcare, our integrated offering is delivered with a deep commitment to quality, transparency and exceptional service.Reliable tech transfer of developed processes following an established approach can be delivered at your site or into our own manufacturing facility.
We can provide process optimization, scale-up and tech transfer of mammalian-based processes to produce monoclonal antibodies, glycoproteins, complex fusion proteins and other recombinant proteins.
Our team has significant experience in developing and scaling up high-yielding processes, with a focus on improving speed to clinic or market and reducing costs.
Cell banking, storage and characterization, including master, working and end-of-production cell banks.
Process optimization by media, feed screening & parameter optimization using DoE methodology.
Process development up to 2-5L bioreactor scale.
Manufacturing ability for pre-clinical study.
Process characterization studies to support late-stage development, process performance qualification and regulatory submissions.
Process improvement studies to improve the overall yield of the process.