GRAM opens fill-finish US facility

Grand River Aseptic Manufacturing has discussed details of the cGMP parenteral drug manufacturing, analytical testing, and regulatory filing services facility

Ribbon-cutting ceremony

Grand River Aseptic Manufacturing (GRAM) has marked the grand opening of its newest fill/finish facility with a ribbon cutting ceremony.

Located near Grand Rapids, the 60,000+ sqft large-scale filling facility completes GRAM's $60 million expansion project and triples the company's manufacturing capacity.

Though the facility has been operational since April, the formal celebration was hosted in partnership with the Grand Rapids Area Chamber of Commerce and attended by Grand Rapids Mayor Rosalynn Bliss, Kent County Commissioner Carol Hennessy, and a handful of other guests. Mayor Bliss and GRAM President and CEO, Tom Ross, both gave celebratory remarks reflecting on GRAM's community-minded culture and how far they have come in the 10 years since their inception. GRAM's VP of Operations, Steve Nole, then gave a brief tour of the state-of-the-art facility.

The large-scale aseptic fill-finish facility is equipped with industry leading technologies that support projects using high-speed, state-of-the-art manufacturing and packaging equipment. This aseptic processing facility expansion more than doubles existing square footage to over 100,000 sqft providing access to top-quality parenteral drug manufacturing for all batch sizes.

"The new large-scale, fill-finish facility - within sight of our primary location - will accommodate customer and industry-wide demand for cGMP parenteral drug manufacturing, analytical testing, and regulatory filing services," GRAM said.

The breakdown of the new facility:

FACILITY:

  • State-of-the-art isolator technology
  • Grade C formulation suites
  • Grade C cleanroom
  • Filling suites
  • Laboratories
  • Walk-in cold and frozen storage
  • Future capacity for new technologies
  • Dedicated personal airlocks (PALs) and material airlocks (MALs)
  • Jacketed tanks for heating or cooling
  • Customer viewing rooms
  • Over 60,000 square feet

CAPABILITIES:

  • Biologics and small molecule manufacturing
  • Controlled substance manufacturing
  • Formulation volumes up to 1,000 L
  • Aseptic processing
  • High-speed filling
  • 2R to 50R vial sizes
  • 200 vials/minute
  • Commercial-scale lyophilisation
  • Chamber capacity up to 68,000
  • Single-use-systems, or product dedicated process equipment

EQUIPMENT:

  • Fully integrated, high-speed Bausch+Ströbel filling line
  • IMA LyoMax 17 Lyophiliser
  • SKAN Isolators for filling line and IMA lyophiliser auto-loader
  • BMT Autoclaves
  • Semi-automated Dabrico inspection system
  • End-to-end single-use systems for formulation and filling
  • High-speed Marchesini packaging line

With top-of-the-line equipment, advanced technologies and space for future growth, the new facility significantly increases GRAM's capacity to support the growing demand for US-based pharmaceutical manufacturing.

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