The term refers to drugs that are covalently bound to a water-soluble polymeric carrier or a protein, such as a polymer or antibody. This process improves the delivery of the drug to its target in the body, a feature that decreases its toxicity to healthy cells, and offers enhanced permeability and retention its site of action, such as a tumour cell.
For Solutia PSD, the move extends its existing capabilities in the supply of highly potent drugs, such as cancer treatments, into a growth area, and one that presents a high hurdle for entry.
Solutia has been able to tackle the sector by virtue of a new containment facility it constructed for high potency API production in Bubendorf, Switzerland, last year. The laboratory and small-scale manufacturing equipment at the site allows the safe handling of compounds up to Category IV, as well as the manufacturing of Category III compounds.
Mark Griffiths, director of operations for Solutia PSD, said that the hybrid nature of conjugate compounds makes their processing, purification and analysis highly technical, requiring expertise in the fields of both small and large molecules for process R&D, scale-up and current good manufacturing practice (cGMP.
"The concept of conjugated therapeutics represents the next frontier of anticancer treatment," said Jason Bertola, Solutia PSD's global business development manager for highly potent active pharmaceutical ingredient (API) supply.
Solutia PSD said it is already working on process research and development for clients, as well as scale-up and production of batches of conjugated APIs for clinical trials.
"More than 10 new polymer-drug conjugates have entered Phase I or Phase II clinical trials in the last decade," according to Bertola. He also noted that some of these products have already achieved promising results in Phase II results, and that this should drive additional development activities in this area.
Last December, Solutia filed for Chapter 11 bankruptcy protection, citing onerous financial commitments to its former parent Monsanto that were hampering its ability to compete in the marketplace.