Althea Technologies, Inc., a provider of
development and manufacturing services for biopharmaceuticals and
parenteral drug products, has completed the
installation of a new INOVA H3-5 high-speed syringe filling line. This
line is located in Althea’s large scale & commercial manufacturing
facility in San Diego.
The expanded
capacity complements existing prefilled syringe manufacturing for
clinical supplies and allows Althea to provide its clients with drug
product in prefilled syringes from early development through commercial
supply.
The INOVA H3-5 syringe line operates within a Restricted Access
Barrier System (RABS) and incorporates the ability to fill under vacuum,
which facilitates handling of viscous products and products that
require minimal head space. The line accommodates nested syringes from a
variety of suppliers and can produce batch sizes in excess of 100,000
units. The system incorporates non-destructive, in-process weight
checks to minimize product loss. Rick Hancock, President of Contract
Manufacturing Services at Althea Technologies, commented, “We’ve been
filling syringes for clinical use for over eight years, and the addition
of this new line allows us to continue to meet client requirements as
they progress from late stage development through commercialization.”
The prefilled syringe market is rapidly expanding as it provides
numerous benefits relating to patient compliance and product
differentiation. “With our existing expertise in formulation
development and protein analytics, we can now offer clients an
integrated solution to quickly develop, register, and launch their
products in prefilled syringes,” added Dr. Shabbir Anik, CEO of Althea Technologies.
The line will be available for production of GMP batches in Q1, 2011.