MANUFACTURING STANDARDS

Please Note: Upon our acquisition by Sun Pharma in July 2014, we no longer perform CMO services for external third parties.

Capabilities and Specifications

01

Best in Class Technology combined with Solid Leadership and Experience

  • Over twenty years of parenteral manufacturing experience as a fully integrated pharmaceutical company
  • CMC experts
  • Currently manufacture and release over 40 lots of commercial products annually

02

Development Expertise

  • Formulation Development
    • Lyophilized
    • Liquid
  • Process Validation
  • Technical Transfer
  • Analytical Method Development and Validation
  • Impurity Identification
  • Stability Services
  • Global Regulatory Support
  • Packaging Development

03

Manufacturing Expertise

Non-cytotoxic, non-high potency products only

  • Fully isolated filling line from vial preparation to ISO 5 RABS capping station
  • Multiple product capability
  • Clinical to commercial scale
  • Aseptic process
  • Terminal sterilization
  • Liquid Fill: up to 120 vials/minute
  • Lyophilized Fill: 180 sq. ft. capacity (x2)
  • Automated CIP/SIP
  • Automated vial load/unload
  • Vial sizes from 2 ml to 100 ml
  • 100% fill check (by weight)

Sun Radiopharma's new state-of-the-art commercial vial filling line features:

  • Full integration
  • Automated and isolated aseptic filling
  • Piston and Peristaltic pump technology
  • 100% fill check by weight on all vials
  • Low Oxygen filling for oxygen sensitive products
  • 2ml to 100 ml vial sizes

Sun Radiopharma’s 70,000 sq ft facility in Billerica MA is designed to meet world-wide compliance standards and to produce both aseptic and terminally sterilized (liquid and lyophilized) small volume parenteral products. Sun Radiopharma currently manufactures its own line of diagnostic commercial products (non-radioactiveradiopharmaceuticals) and is currently performing technical transfer tasks to produce Sun injectable products in the near future. The Sun Radiopharma manufacturing and testing groups are supported by a comprehensive Quality Management System.

The manufacturing scale at our new Billerica site is up to 34,000 10cc vials per batch for lyophilized products and 14,000 10cc vials for terminally sterilized products.The filling line, manufactured by Bosch, is fully isolated. The IMA/Life lyophilizers include an auto load/unload system. Theline is designed to handle vial sizes from 2cc to 100 cc and incorporates 100% fill check by weight. The filler has the capability to dispense product solution by peristaltic or piston pumps.

The Sun Radiopharma Quality Control group maintains a full range of analytical test equipment and has extensive experience with the transfer and validation of methods. Sun Radiopharma services include access to a cGMP warehouse with refrigerated and freezer storage for incoming material, intermediates and/or drug product.Full ICH stability storage is also utilized.

Product classes currently manufactured in the facility are all non-potent, non-cytotoxic. All product manufacture is supported with specific cleaning validation.

Sun Radiopharma has extensive manufacturing expertise with small volume parenterals, including fill volumes ranging from 0.5 mL to 5 mL. All products undergo 100% visual inspection. Sun Radiopharma maintains a full complement of labeling and packaging operations.

Lyophilization is crucial for many parenteral drugs and biologics. Many therapeutic agents lack long stability if kept as a solution. Complex molecules left in liquid form may undergo a variety of reactions which may compromise both potency and safety. Additionally, in solution, many drug substances are susceptible to even modest changes in temperature and chemical environment. Lyophilization overcomes poor stability by rendering labile drugs and proteins in a solid form more tolerant of long-term product storage.

Our Billerica facility features two IMA/Life 180 sq. ft. lyophilizers, each capable of processing 34,000 10cc vials in a single manufacturing cycle.

A stable lyophilized drug can:

  • Facilitate long distance transport and storage
  • Withstand adverse environmental challenges