Fill Finish Capabilities at Alkermes Contract Pharma Services, Ohio, U.S.A. Vial Fill Rooms Fill Finish Facility in Ohio, U.S.A. • Aseptic vial powder and liquid filling • Grade A filling zone with Grade B background • Glass/lexan partitions around filler • Dedicated redundant air handlers under AB PLC control • Pressure Monitoring • Hard Balanced pressure cascade • 0.08” steps x 5 steps Key Features • Continuous SCADA monitoring • Aseptic vial powder and liquid filling • dP Alarms @ 0.01” after 300 seconds • Located on 24 acres with 200,000 sq ft square feet of space • Temperature Control and Monitoring (62°F+/-5) • Humidity Control and Monitoring 35-60% RH • Operates under cGMP standards • Recirculation: ~10% outside air • Audited by FDA, MHRA, ANVISA and other regulatory authorities Utilities • Manufactures product for U.S., EU/ROW, Japan, China, Russia and CIS markets • Clinical and commercial scales • Vials and pre-filled annual capacity − 10 million vials − 2 million syringes available by 2013 Site Strengths • Multi-Product Facility • Experienced highly-skilled workforce with high work ethic and standards • Aseptic filling in dry powder and liquid fill single dose vials and prefilled syringes • Vial Inspection to ensure final quality attributes are met • A focus on partnering with customers • Excellent site compliance • Includes WFI, Clean Steam, Compressed air and Solvent Tank Farm. Contract Services • Technical Support for drug product (including biologics) • Analytical testing • Product Inspection of liquid powder vials and prefilled syringes • Regulatory submission and support • Dossier support • Validation • Project Management. For More Information: Philip Pratten, VP Business Development [email protected] or [email protected] record © 2012 Alkermes. All rights reserved. Fill Finish Capabilities at Alkermes Contract Pharma Services, Athlone, Ireland Fill Room • Aseptic vial powder and liquid filling • Dispensary - Grade C dispensary area with glovebox isolator available for potent or hazardous materials • Compounding - Grade C area, accommodates up to 1,000 Liters • Vial Washing - Integrated U shape filling line, with Grade D viewing corridor Fill Finish Facility in Athlone, Ireland. • Vial Filling - Grade A area, filling 2ml-100ml vials at 120vials per minute, 100% weight check Key Features • Capping/Labelling - adjacent to filling room, Grade A conditions for capping, labelling adjacent in Grade D room • Biopharmaceutical Sterile Fill-Finish facility • Licenses by Irish Medicines Board (IMB) in mid-2008 • Designed to fill liquid products • Meets FDA/EMA/JMHLW GMP Guidelines • 42,000 sq. ft of cGMP manufacturing capacity • Clinical and commercial scale • 20M unit annual capacity for biologics and small molecules • Multi-product facility, capable of filling a range of vials in liquid form • Batch sizes from 2-1,000 Liters Utilities • Includes WFI, Clean Steam, Compressed air Status of Facility • Facility is kept in ‘readiness’ status and with continuous monitoring essential equipment and facilities maintained • Various commercial options for the plant can be explored with partners. For More Information: Philip Pratten, VP Business Development [email protected] or [email protected] © 2012 Alkermes. All rights reserved.