Albany Molecular Research (AMRI) operates a cGMP manufacturing sterile fill and finish facility in Burlington, Massachusetts, US. Originally owned by Hyaluron, the facility was acquired by AMRI on 17 June 2010 for $27m.
The facility offers a full range of services from preclinical through commercial scale production of liquid-filled parenterals, biologics and medical devices in vials, syringes and other custom containers.
The facility is ISO 9001 and 13485 certified, and is FDA inspected for drug and medical device. It was approved by the Italian Medicines Agency (AIFA) on 3 February 2011 for the production of octreotide, a commercial drug. The approval was granted following a successful AIFA audit of the facility during the last quarter of 2010.
Sterile fill and finish facility
The facility spans 60,000ft² with dedicated space for manufacturing, clean rooms, laboratories and administrative activities. Three fill lines have been installed across three aseptic fill suites. The first aseptic fill suite houses the lyophilisation unit and the INOVA VFVM-3031 vial filler.
The line has a single star wheel set up and operates at a capacity of up to 75,000 vials per batch with vials ranging between 2ml and 100ml. It performs automated filling and capping and offers a three-fill needle format including pre-gas purge, product fill and post-fill headspace. It also has a unique suction stopper placement, inline class 100 capping area and an online automated inspection facility. Other specifications of the line include a low hold-up volume of up to 30ml.
Lyophilisation is performed in a BOC Edwards Lyomax 3 lyophilisation unit. The unit is designed with a programmable recipe automation that offers repeatability of multiple lots. It can perform lyophilisation for up to 12,000 vials per batch. The unit has six product shelves totalling 36ft² in area with a shelf inter distance of either 69mm or 140mm.
Three removable trays perform lyophilisation for vials ranging up to 250ml in size. Lead / lag circulating pumps for shelves and condenser and redundant systems for compressors and vacuum pumps have also been installed.
The second and the third aseptic fill suites accommodate two syringe filling lines. An INOVA H3-5V commercial scale syringe filler is installed within the second aseptic suite. The line can fill 100,000 syringes a day (or batch), each syringe measuring between 0.5ml and 5ml in size. It has been designed for Bubble-Free Filling, online vacuum filling and online vacuum stoppering. The line works on a 3/5 head filler positive displacement system.
The INOVA SV-122 syringe filler is installed within the third aseptic fill suite. The line is custom designed to fill 0.5ml to 20ml syringes at a capacity of 50,000 syringes a day or batch. It features a disposable product pathway and works on a 1/2 head filler positive displacement system. It functions at a fill precision of ±0.03ml with an option of variable depth stoppering and features a low hold-up volume of up to 30ml.
Custom container filling capabilities within the facility include small volume fills up to 1l in screw-top bottles and mini vials.
The facility undertakes all aspects of formulation / filling / finishing of drugs from the preclinical phase to the commercial phase of development. It offers syringe, vial and custom container filling services, lyophilisation services and stability optimisation services (SOS) for both small molecule drug products as well as biological drugs.
The facility uses online vacuum filling and online vacuum stoppering method for pre-filled syringes for low-viscosity liquids.
For oxygen-sensitive compounds including proteins, epinephrine and others, where the solution stability is negatively impacted by the dissolved oxygen, a unique patented technology developed by Hyaluronis is used. Known as Bubble-Free Filling, the technology ensures sterility by reducing the movement of stopper and creating an environment that is unfavourable for the growth of aerobic micro-organisms.