Althea Technologies, Inc., a leading provider of development and manufacturing services for biopharmaceuticals and parenteral drug products, recently announced it has completed the installation of a new INOVA H3-5 high-speed syringe filling line. This line is located in Althea’s large-scale and 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.

“We’ve been filling syringes for clinical use for over 8 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,” said Rick Hancock, President of Contract Manufacturing Services at Althea Technologies.

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.

Althea Technologies is a fully integrated, contract development and manufacturing organization that provides services for plasmid DNA, recombinant proteins, and sterile products. Located in San Diego, Althea offers cell banking, process development, cGMP protein & plasmid production, analytical development, formulation and lyophilization development, and aseptic filling in vials and prefilled syringes for clinical development and commercialization. Althea’s technology platform for protein formulations employs crystalomics that can be applied to a variety of peptide and proteins for high concentration or sustained release formulations.  For more information, visit www.altheatech.com.

source: web of drug delivery tech