Millipore India which has developed a solid platform in upstream process technology, is now aggressively working to market Incelligent AF, a recombinant insulin for cell culture application that is vegetable based.

Incelligent AF insulin is a complete animal free product used to optimize cell culture media and support animal-free regulatory filings. It does not have either bovine or porcine components.

The company has adopted a five-point definition of the term animal-free for its biologically-based cell culture supplements. There are no animal-origin components in the Master Cell Bank (MCB), working Cell Bank (WCB), raw materials, manufacturing process and final product helping to fulfil all five criteria to be labelled as 'animal free'.

Global bio-therapeutics manufacturers are moving away from animal derived products for their cell culture applications. A visible trend is to reduce the risk of contamination and virus risks from media of animal origin, informed Dr Subhasis Banerjee, manager Process Applications, Bioprocess, Millipore India.

Incelligent AF insulin is a biosynthetic, white powder, produced by recombinant expression in yeast, 'Saccharomyces cerevisiae.' It contains a synthetic gene insert which codes for expression of a human insulin precursor. It is identical in structure and functions to the native human sequence, he said.

The key features of Incelligent AF are: no risk of contamination because it is vegetable-based unlike those derived from animal sources. The product provides consistency during the manufacturing process and allows traceability of raw materials used to make it. It has already been utilized in many FDA approved facilities world wide.

Although there are many other companies dealing with insulin culture, most of them are animal based. It was in 2006, the parent company Millipore Corporation acquired Serologicals. During the process, Millipore got hold of the product portfolio of Celliance, a subsidiary Serologicals. This helped Millipore to storm into the Upstream area of cell culture.

Going by the growth of the biotech sector in the country and with biologics being a high value segment, Millipore is keen to en-cash the lucrative opportunities. The company will provide both technical and application support to its customers to increase its market reach.

Serum-free media supplements like recombinant human insulin are essential for long term growth of various cell lines. It plays a key role in stimulating the proliferation of cells and cell growth. Besides improving productivity, insulin increases the stability of cells in cell culture. Insulin being a polypeptide hormone it stimulates carbohydrate metabolism.

When recombinant human insulin is absent from media, cells are likely to exhibit disturbances in morphology and growth rate. As a consequence, many of the therapeutic products in production and development including monoclonal antibodies and recombinant proteins are being produced in media that incorporates recombinant human insulin in its formula, said Dr Subhasis Banerjee.