Formatech continues to be a leader in their niche market as the demand to outsource pharmaceutical product development and manufacturing continues to soar. Formatech, a contract services provider based in Andover, MA, has distinguished itself as an industry leader through their proven ability to expeditiously bring a client’s potential product to market.

Formatech’s success can be attributed to their dedication to excellence and forward-thinking strategies. This philosophy keeps them abreast of the latest outsourcing trends and needs of their pharmaceutical and biotech customers. “Contract product development is the only way the industry’s drug development efforts can hope to keep pace with drug discovery,” states Ben Isaacs, Ph.D., founder and President, Formatech. These include Development of Pre-Formulation, Formulation, Dosage Form, Lyophilization, Cell Culture/Fermentation, Purification and Analytical Development and Validation. As such, Isaacs adds that Formatech continues to expand its service offerings to meet the changing demands of their customers.

Founded in 1993, by Dr.’s Benjamin Isaacs and Indu Isaacs, Formatech was established to provide formulation development services to a growing biotechnology industry. Their expertise and success in formulating recombinant proteins and antibodies is well documented. “A trend in the marketplace is to develop or formulate drug products in a manner that makes them convenient to administer. This is especially challenging for protein therapeutics, such as monoclonal antibodies, where the dose can be as high as 300mg and the preferred route of administration is by subcutaneous injection” says Benjamin Isaacs. Formatech’s approach to formulating protein products begins with its Stability FingerPrinting Program™. Stability FingerPrinting is a program designed to elucidate inherent instabilities in the therapeutic protein, thereby facilitating a rational formulation development program to deliver a stable product. This approach has been successfully applied to many different classes of potential drug products, including proteins, protein-conjugates, peptides, viral and non-viral vectors, etc.

Recognizing their client’s needs for increased services, Formatech has continually expanded their services portfolio as follows:

·    1995 – Downstream Process Development
·    1996 – Formulation development for all classes of molecules & all common  dosage forms                                                        
·    2001 – cGMP Manufacturing facility for small scale, aseptically processed parenteral products
·    2004 – Cell Culture / Fermentation Development

Additionally, Formatech plans to expand its manufacturing capabilities in late 2005.  Efforts are underway to construct a manufacturing facility to accommodate commercial manufacturing operations.

Their innovation continues through 2005 as Formatech has developed a proprietary formulation platform that will be commercialized and out-licensed through their newly established, neuMirRx Corporation. “This novel technology is directed at enhancing drug solubility and/or bioavailability without the use of undesirable, and often times noxious, excipients such as cremaphore and ethanol among others,” explains Isaacs. Resulting formulations will demonstrate improved levels of solubility and stability.

As the demands of this niche market continually change, Formatech will adjust to fulfill their client’s specialized needs.  Isaacs clarifies, “We are not a CRO [contract research organization] in the classic sense of managing clinical trials, nor are we like other CRO’s who try to do everything. We prefer to call ourselves a development services company. We take on projects in all phases of development, focusing our attention on issues of process optimization, pre-formulation, formulation, dosage form development, lyophilization development, clinical trial and  small scale commercial product manufacturing.”

Fir further information, please go to www.formatech.com.