Technology - Formatech: A History Of Success Through Innovation & Expertise
(Indu J. Isaacs, Ph.D., CEO and Co-founder of Formatech, has a Ph.D. in Chemistry from University of Oklahoma. Dr. Isaacs, has 20+ years of experience in Product Drug Development of Pharmaceuticals and Biologics. In 1993, Dr Isaacs Cofounded Formatech and then joined Formatech in 1998 as its Chief Executive Officer. )
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‚Äôs potential product to market.
Formatech‚Äôs 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. ‚ÄúContract product development is the only way the industry‚Äôs
drug development efforts can hope to keep pace with drug discovery,‚ÄĚ
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.‚Äôs 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. ‚ÄúA 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‚ÄĚ says Benjamin Isaacs. Formatech‚Äôs approach to
formulating protein products begins with its Stability FingerPrinting
Program‚ĄĘ. 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.
client‚Äôs needs for increased services, Formatech has continually
expanded their services portfolio as follows:
¬∑ 1995 ‚Äď Downstream Process Development
¬∑ 1996 ‚Äď Formulation development for all classes of
molecules & all common dosage
¬∑ 2001 ‚Äď cGMP Manufacturing facility for small scale, aseptically processed parenteral products
¬∑ 2004 ‚Äď 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.
‚ÄúThis 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,‚ÄĚ
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‚Äôs specialized needs. Isaacs clarifies, ‚ÄúWe are not a CRO
[contract research organization] in the classic sense of managing
clinical trials, nor are we like other CRO‚Äôs 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.‚ÄĚ
Fir further information, please go to www.formatech.com.
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