20 MARCH 2015 ◗ pharmpro.com
ORAL SOLID DOSAGE TECHNOLOGIES
Looking for a Challenge?
Try designing a flexible potent compound multi-product
generic OSD plant
Successful generic oral solid dos- age (OSD) drug manufacturers and contract manufacturing organizations (CMOs) strike a seemingly impossible balance
between low cost and high flexibility.
Current research suggests that the pressure on these organizations to continue
to drive down costs while simultaneously
positioning themselves to exploit new
business opportunities will only greaten
in the foreseeable future. According to
the Generic Pharmaceutical Association
(GPhA) 2015 annual cost savings report,
generics saved the U.S. economy $239
billion in 2013, a 14% increase over cost
savings achieved in 2012. The growth
inherent to this overall cost savings is
astounding. New generic products entering the market in 2013 saved the national
healthcare system $140 billion alone. The
roughly $98 billion in savings provided
by established generic products has
remained fairly constant over the past decade. This means
that to remain competitive in the exploding generic OSD
market, manufacturers must find ways to expand their
product portfolios while continuing to supply their customers with established products at historical volumes.
For leading generic OSD suppliers and their CMOs,
expanded portfolios will include potent compounds, and
potentially special class products, such as hormones, steroids, cytotoxic products, or beta-lactams. With increasing
pressure to control capital expenditures, generics and
CMOs will not have the luxury of building lavish Greenfield
campuses with dedicated single-product facilities. Rather,
low cost suppliers will be faced with the challenge of
retrofitting existing plants, many of which were not
designed to manufacture potent or special class products.
Organizations with the benefit of sound forecasts may be
able to justify new facilities, but these will likely be required
to handle a multitude of current and future products with
diverse potencies and characteristics.
Our friends in operations are cringing at the preceding
allusion to “…sound forecasts....” Generics suppliers may
accurately project demand for established products, but
the reliability of the forecast crumbles at new or future
products. This unpredictability drives up the capital invest-
ment risk of construction, expansion or retrofit for the
purpose of new or future product manufacturing. The chal-
lenge in assigning product development and technology
transfer resources is equally daunting, and the investment
risk extends to new equipment and facilities required for
product development and scale-up.
On the bright side, OSD suppliers and CMOs that manage these investment risks effectively stand to reap vast
rewards by capitalizing on the unprecedented growth of
the generic drug market. Successful manufacturers will
align themselves with experienced professional resources
who understand the intricacies of OSD facility master planning, design, construction and validation.
The winning team must first identify the business drivers for the project. Drivers may include the need to achieve
or improve regulatory compliance, or the expansion of
manufacturing capacity (quantified, perhaps in annual unit
volume) for a specific product portfolio. Business drivers
◗ By Andrew Christofides, P.E., Michael Vileikis, Paul Valerio, Sam Halaby - IPS and Russ Somma, Ph.D. -
Sommatech Consulting
Andrew Christofides
Michael Vileikis
Sam Halaby
Russ Somma
Paul Valerio
