Kemwell provides integrated development and manufacturing services for companies that require one-stop solution for mammalian cell-culture based protein therapeutics – monoclonal antibody, bi-specific or multi-specific antibodies, fusion proteins, etc. The team is experienced to undertake end-to-end activities right from cell line development till cGMP clinical manufacturing or even cGMP commercial manufacturing. Kemwell Biopharma is partnered with few leading multinational cell line companies. Kemwell’s experienced team works actively with cell-line partners not only to develop robust cell lines, but also to efficiently transfer the cell lines at Kemwell facility for process development, analytical development and undertaking further scale-up & manufacturing activities. In today’s competitive market Kemwell technical leadership understands the need for high impetus to undertake cost-effective manufacturing and that is why the team ensures that manufacturing yields and costs are measured and optimized right at the stage of development and during each scale-up activity too; most importantly by maintaining high standards in product quality all through out the development.
The state-of-the-art drug substance and drug product (fill and finish) manufacturing units are audited by regulators, former USFDA inspectors (as part of a PAI planned in next year), EU QPs and various multinational partners of Kemwell. The team has good understanding of US, EU and various other established markets’ requirement and can support your IND, BLA, PMDA or EMA filings.
Below is indicative timeline that Kemwell team follows from cell line development to clinical phase 1 manufacturing:
Being a trusted 100% biologics CDMO, all product related IPs are fully owned by our partners. Kemwell uses of advanced data protection and maintains highest transparency with partners regarding the activities, reports and documents. The team has implemented LIMS (for QC activities), CSV (for GMP activities) – in line with 21 CFR part 11, EU annexure 11 and GAMP 5- SAP (for batch release activities), EMPOWER server system (for tracking HPLC activities), live tracking systems (for all control areas) and created centralized lab servers for monitoring lab activities. The team is also on track to implement planned advanced LMS, QMS and DMS systems.