Drug Delivery Development Manufacturing Facility

SurModics Pharmaceuticals' new commercial manufacturing facility

 

Commercial Manufacturing Facility

SurModics Pharmaceuticals’ recently acquired facilities
(286,000 sq. ft.) to expand commercial manufacturing

 

[Image] Clean room

View of a SurModics Pharmaceuticals clean room

 

[Image] Exterior of Brookwood Pharmacueticals facility

A SurModics Pharmaceuticals facility

SurModics Pharmaceuticals facilities

  • Corporate Headquarters and manufacturing facilities located in Birmingham, Alabama
  • Multiple clean-room suites
  • Three clean-room suites that can be operated independently for drug and drug delivery products
  • An additional clean-room suite (3 rooms) dedicated to biomaterial production
  • Purpose built for terminally-sterilized parenteral formulations (Low bioburden/particulates)
  • Class 100 to Class 100,000 (ISO 5 to ISO 8)
  • Supporting utilities and Quality Systems

 

Our three cGMP facilities include:

  • ~ 650 sq. ft. of classified area within each suite
  • ISO Class 5 to 8, temperature and RH controlled
  • Quarantine and storage areas for each suite
  • Qualified utilities
  • Qualified environmental monitoring
  • Qualified refrigerators and freezers

SurModics has extensive experience in the production of clinical trial material.  Over the last several years, a significant number of batches for Phase I - III clinical trials have been produced and released.  These products have ranged from microparticles and extruded rods that were terminally sterilized to aseptically produced microparticle and liposome formulations.  Highly potent aseptic formulations using barrier technologies have also been produced for clinical trials. The scale of clinical production lots has ranged from a few grams per lot, to greater than 75 kilograms per lot.

 

SurModics has recently announced the purchase of a new facility for manufacturing expansion.  This is a 286,000 sq. ft. facility. This expansion equips the company as a full-service partner in assisting clients in product development and supply at every stage from early feasibility to production of marketed products. The new facility will expand SurModics’ capacity for development on customer projects and ability to perform clinical and commercial cGMP manufacturing of drug delivery products for pharmaceutical and biotechnology customers.