Ferro Pfanstiehl Laboratories has commissioned a new validated current good manufacturing practice (cGMP) supercritical fluid-based particle engineering pilot facility, offering sizing, purification and formulation services to its pharmaceutical customers.
The $500,000 (€390,000) facility in Waukegan, Illinois, will provide International Conference on Harmonization (ICH) Q7A-compliant small-scale manufacturing of drug particles and compounds for use in Phase I and II clinical trials and feasibility studies of engineered particles for any desired drug delivery application.
Thus, Ferro is hoping to enhance its pharma business from being a custom manufacturer and supplier of specialty fine chemicals and active pharmaceutical ingredients (APIs) to a product development partner that offers controlled release, taste masking, respiratory, transdermal and injectable drug delivery applications.
"Our strategy was to first build our technology platform and then make it available to our clients, who can use it not just for formulation development but also for process improvement, for example in purification," Pratibhash Chattopadhyay, Ferro's director of pharmaceutical technology, told In-PharmaTechnologist.com.
"We entered the pharmaceutical industry as a contract manufacturer but our final goal is to become a licensing partner and jointly bring new products to market."
The company has developed patented supercritical fluid (SCF) technologies that utilise low-cost carbon dioxide to produce nano- and micro-particles with a narrow size distribution and consistent morphology.
Manufacturing benefits, according to Ferro, include reduced operating costs, near elimination of waste streams, easy recycling of organic solvents, and reduced cycle time.
Supercritical fluid extraction of emulsions (SFEE) is the most prominent amongst Ferro's technologies, as it expands on established emulsion-based particle precipitation process/SCF extraction technique by combining particle engineering flexibility with the efficiency of large-scale continuous SCF extraction to produce 10nm to 100µm particles of small actives, lipids, polymers and some biologicals for controlled release, improved dissolution, nano-suspensions and injectables.
Chattopadhyay said the method is unique in that it allows continuous production and yields particles of very fine quality.
The Illinois-based firm also offers spray freeze-drying (SFD) at faster rates than the conventional method, provides single-step lyophilisation of proteins, biologicals, excipients and some APIs in 10µs to 100µs and resulting in uniform porous and hollow particles in a size range of 0.1µm to 50µm for respiratory applications and stable protein formulations.
Supercritical antisolvent precipitation is also available, combining enhanced mixing of drugs or polymers with SCF extraction to produce 1µm to 20µm homogenous particles of small actives and some biologicals for first-generation dry powder inhalers (DPIs), pressurised metered dose inhalers (pMDIs) and oral APIs.
Finally, in the expansion of gas saturated mixtures, SCF diffusion of sprayed SCF-saturated and plasticised drug/polymer mixtures produces porous particles in size ranges of 0.5µm to 300µm of polymers, lipids, biologicals and small molecules for controlled release or taste-masking without the use of an organic solvent.
Ferro claims these novel technologies have been validated through a myriad of successful feasibility projects and so are available for licensing on a fee-for-service basis, ideal for pharmaceutical companies that are exploring SCF technology or are using it but need the ability to produce a different particle type than those achievable with in-house resources.
The new facility can perform each of the different technologies to create particle sizes and types for a nearly unlimited range of drug delivery applications, the company said.
The fully integrated Class 100,000 SCF particle engineering facility includes reactor volumes up to 8L able to produce multiple kilogram quantities of clinical trial material.
It compliments Ferro's full-service API and high potency API development and manufacturing capabilities, which include a SafeBridge-certified commercial scale containment chemistry facility that is one of the largest in North America.
The facility is the latest in a series of capital investments at Ferro, including a new Class IV containment 'kilo lab' in February of this year and an analytical services laboratory in April 2004.