Dowpharma completes commercial-scale oligos cGMP manufacturing facility

Dowpharma, a business unit of The Dow Chemical Company, has now completed the construction of its commercial-scale cGMP oligonucleotide manufacturing facility. Designed for the large-scale manufacturing of oligonucleotides, the multi-product facility has the flexibility to produce approximately half a metric ton annually, depending on product mix.

The new facility is located in Midland, Michigan, where Dowpharma currently operates a cGMP lab-scale facility to produce material for early toxicology and clinical trials (10-100g) and a mid-scale cGMP manufacturing facility, with the capability to produce multi-kilogram quantities on a campaign basis for later stage clinical trials and stability testing.

At present, Instrument Qualifications (IQ) and Operational Qualifications (OQ) are being conducted at the new facility. Dowpharma plans to run the first validation batches before the end of the year.

'We made this investment as a direct response to clients' needs,' said Nick Hyde, business director, Dowpharma. 'We wanted to be able to support our clients throughout the lifecycle of their drug - from toxicology through clinical to long-term commercial supply. Building this world-class facility is one more example of our growing commitment to nucleic acids long-term with our intention to become the leader in oligonucleotide manufacturing.'

Dowpharma has already demonstrated success in oligonucleotides. Several projects for multiple clients have been completed under cGMP conditions at scales ranging from a few grams to multiple kilos. 'Our cGMP manufacturing capacity is supported by our strengths in process development, engineering science, analytical sciences and regulatory compliance,' Hyde added.