CPhI Day Two: Complexity Prevails
I combed the disperse and multi-tiered halls of the Frankfurt Messe today, immediately picking up on one of the themes put forth at Monday’s conference. Ashland and Dow announced new drug dispersion polymer product line extensions. Both companies are addressing the need to improve the dispersion and delivery of complex molecules that are beginning move forward in the pipeline.
Christophe Massip, global marketing director for Dow Pharma & Food Solutions notes that 70 percent of the drugs across current industry pipelines are now rated Class 2 (poorly soluble), or Class 4 (poorly bioavailable). In essence, all the low hanging fruit of easy soluble molecules has been picked in drug R&D, he says.
Massip’s division, by the way, is one of five at Dow, including Dow Polyglycols, Surfactants and Fluids and Dow Water & Process Solutions, contributing to a new Dow Healthcare division that will focus on drug delivery, process purification and separation, and active pharmaceutical ingredients.
Several companies, including the French firm Novasep, report new FDA inspections for high potency APIs, antibody drug conjugates, and other advanced technologies, responding to an increase need for high tech products and services. Some, like Fabbrica Italiana Sintetici (FIS) in Vicenza, Italy, are making big investments in R&D, upping high potency capacity and experimenting with flow chemistry.
The “new complexity” in API supply “does not come only from the molecule and the chemistry, but also from an increased uncertainty about what our customers will request,” says Franco Moro, general manager of FIS. “Outsourcing is not just outsourcing the product. It is outsourcing of services, including R&D, analytical and regulatory services, and quality”
In broadening its offering, FIS, in fact, has done some sub-outsourcing, forming several manufacturing and service partnerships. The company has been working with Enantia, a Spanish firm specializing in chemical R&D, and with a partner in the U.K. on crystallization research. FIS also has a Chinese partner manufacturing APIs.
Andreas Weiler, head of strategic marketing at SAFC, closed the day with a talk in the Messe Forum entitled, “Is There a Future for Western CMOs,” referring to contract manufacturing organizations serving the drug industry. His answer boiled down to “yes,” as long as they are ready to deal with the kind of drugs that have been introduced in the last two years—drugs that will require low volume, high potency APIs.
More on all this and a gloss of announcements at the press conferences tomorrow.
Cultural Note: I plan to revert to images from the Städel collection tomorrow, unless another excellent choice of images from the show presents itself.