Solid state chemistry – which concerns the physical solid form properties of active pharmaceutical ingredients – is a critical component of the early-stage development of new drug candidates.
For Almac it provides a critical formulation link between drug substance and drug products, said Dr David Moody, Almac’s vice president, commercial operations at a press conference at the CPhI show in Frankfurt last week.
Almac now claims to be one of only a handful of API contract service providers with expertise in solid state chemistry, and an even smaller number that provide it alongside other services on one single site. That proximity can make a real difference to the speed of a project, and that can have a big impact on time to market, said Linda McCausland, group leader, physical sciences at Almac, in an interview.
Solid state chemistry is important in API development as it has a bearing on bioavailability and dissolution, as well as the intellectual property estate for new compounds.
APIs can exist in a number of forms that can have a dramatic effect on the performance of the drug, and if companies are not careful to identify and patent them all it can open a door for the early entry of generic rivals.
“If you miss a form , you can have terrible problems with IP,” she said.
A good example of that was Dr Reddy’s launch of its cardiovascular drug AmVaz (amlodipine maleate), a different salt of Pfizer’s big-selling Norvasc (amlodipine besylate) brand, back in 2004. Pfizer subsequently won the IP litigation in this case, but would no doubt have preferred not to have to go to the expense of that courtroom battle.
Almac has been careful to provide a broad range of services in the solid state business, that are applicable at each stage of the drug development process.
Early on, the primary aim is to screen a whole range of solid forms of an API to find those with the best profile in terms of solubility, bioavailability and solubility, said McCausland.
“By exploring polymorphs, salts co-crystals and amorphous materials Almac can dramatically improve the characteristics of APIs,” she added. And that effort also yields optimal crystal forms that will provide consistent material later on in product development.
After the lead solid forms are identified, the emphasis changes and Almac’s scientists try to identify as many different solid forms as possible “to cover the IP landscape.”
Almac Sciences has been gradually expanding its portfolio of services through a series of acquisitions and capital investments in recent years, adding cytotoxics, peptide chemistry and conjugation technology as well as radiolabelling expertise. The solid state services unit is the latest addition, but unlikely to be the last.
The company also said that it would be expanding its capabilities in biocatalysis “within the next few months.”