Acquiring Hyaluron gives AMRI capacity for current good manufacturing practice (cGMP) production and sterile filling of parenteral drugs. This moves AMRI into the prefillable syringe contract manufacturing sector, which is set to grow as biologics use increases.
Having made the buy AMRI is able to offer clients a fully integrated production process for sterile injectables. This includes development and manufacture of active pharmaceutical ingredients (API), design of the criteria to formulate the injectable, and production of the finished product.
“We believe that the unique capabilities of both organisations will quickly assimilate into a larger, fully integrated GMP manufacturing provider of choice for companies desiring to capitalise on seamless technology transfer”, said Thomas D’Ambra, CEO of AMRI.
The benefits of this integration include “increased efficiency and cost benefits”, said D’Ambra.
AMRI has paid $27m, including debt, to acquire Hyaluron’s facilities, equipment and staff. The deal includes the patented Bubble-Free Filling technology developed and owned by Hyaluron.
Using the vacuum filling and stoppering technology Hyaluron can fill products without gas bubbles. This is beneficial when handling oxygen sensitive compounds, such as proteins, which can become less stable when exposed to oxygen.
Furthermore, Bubble-Free Filling creates an unfavourable environment for the growth of microorganisms and reduces the threat to sterility caused by accidental low level contamination.
From its site in Burlington, Massachusetts, US Hyaluron provides filling of liquid and lyophilised products into syringes, vials and custom containers. This can be preformed at scales ranging from preclinical to commercial.
Particular expertise includes process development for difficult formulations, such as emulsions, viscous gels, suspensions, liposomes and proteins. Hyaluron also provides stability testing for clients to evaluate the shelf-life of products in different containers, such as vials and syringes.