Stelis Biopharma Pvt. Ltd opened a Joint Process Scale-Up Lab at its biologics R&D facility in Bengaluru (Bangalore), India this week in collaboration with MilliporeSigma, Merck KGaA’s life science division.
The centre intends to bring together Stelis’ capabilities in process development, from cell line to commercial manufacturing scale, with Merck’s technological expertise and will be equipped with the latter’s Mobius range of single-use bioprocessing equipment.
“Merck’s Life Science offered an integrated solution for our bioprocess needs from scale-up through to manufacturing. It helped that their portfolio spans the whole biopharma value chain from upstream and downstream processing including reagents and media from Sigma-Aldrich [which Merck acquired in 2015],” Stelis’ CEO Joe Thomas told Biopharma-Reporter.
The partnership goes beyond a simple vendor-pharma contract, he continued, adding Merck “will support the establishment of single-use good manufacturing practices at our scale-up lab through continual training and sharing of best practices and create a quality led center of excellence for single-use technologies.”
Indian biomanufacturing
India is a well-established hub of small molecule API and finished formulation manufacturing but bioproduction remains limited due to a lack of investment, government support, and skilled workers.
“The earlier model of Indian generic companies with strong domestic franchise investing in capacities to meet international requirements, is not practical in a biopharma setting,” Thomas told us. “Unlike generics, biosimilar uptake is relatively low in India because of their high cost, and biomanufacturing capacity creation is much more resource intensive than in small molecule.”
The country has also garnered a reputation for quality issues, following a string of regulatory warnings and import alerts, but according to Thomas the implementation of disposable equipment could help increase compliance and encourage the bioproduction sector.
“We believe that single-use technologies will dramatically improve quality and compliance by eliminating possibility of cross-contamination through use of disposable components. Also, the high level of process controls through automation eliminates manual interventions and enhances traceability of process parameters giving greater comfort to regulatory authorities,” he said.
“The higher batch cost on account of disposables will be offset by the reduction in batch failures, faster change-over between batches, no cleaning validations, lower utility cost and greater capacity utilisation.
“This should certainly attract more global bio-manufacturing into India.”
The original article stated Stelis is a fully owned subsidiary of Strides Arcolab. This is no longer the case and the firm's principal shareholders are Strides Pharma, Tenshi Life Sciences Private Limited, and GMS Holdings.