Pegylation of biologics, peptides and small molecules is increasingly common, according to Dr Reddy’s, as companies seek to improve pharmacokinetics of treatments by prolonging their half-lives. In turn, this is driving demand for the materials used in pegylation.
To ensure supply of mPEG alcohols, raw materials for activated mPEGs, Dr Reddy’s has commissioned a commercial scale production facility in Cuernavaca in central Mexico.
Speaking to in-PharmaTechnologist, Nick Johnson, commercial director at Dr Reddy’s, and Mark Pearson, PEGtech product manager, explained that Mexico was chosen as the location because of the “technical synergies” and economic advantages it offers.
Dr Reddy’s has made the “significant investment”, more precise details of which Johnson and Person would not disclose, to bring mPEG alcohol production in-house, having previously sourced it from Dowpharma.
The current good manufacturing practice (cGMP) compliant plant has a multi tonne annual capacity and the ability to produce a wide range of molecular weight mPEGs. Products from the Mexico facility will be transferred to Dr Reddy’s site in Mirfield, UK for downstream processing.
Johnson and Pearson believe the safety and stability of mPEG alcohol, coupled to Dr Reddy’s experience of transferring materials between its global sites, will ensure the supply chain logistics are unproblematic.
Products manufactured using raw materials from the Mexico facility, which has completed test runs and is now operational, will form Dr Reddy’s PEGtech brand of activated mPEGs. Satish Reddy, managing director of Dr Reddy’s, believes this will be an attractive product portfolio.
“By introducing the PEGtech brand, our customers can be assured of the same high quality standards and customer service as they develop their PEGylated biologic drugs or small molecules from the laboratory right through to commercial applications”, explained Reddy.