Pace Life Sciences – People Advancing Science
HQ: Oakdale, MN
1311 Helmo Avenue North
Oakdale, MN 55128
T: (651) 738-2728
W: www.pacelifesciences.com

Additional CDMO/CRO network site locations:

Boston, MA
Salem, NH
San Diego, CA
Norristown, PA
Ann Arbor, MI
South New Berlin, NY
San German, PR

PHARMACEUTICAL CMC DEVELOPMENT (CDMO)

PEOPLE ADVANCING SCIENCE

Pace^® Life Sciences provides a full suite of contract CMC development, CTM manufacturing, regulatory compliance, consulting, and facility support services to the pharmaceutical, biopharmaceutical, and gene therapy industries. Pace^® Life Sciences operates from a network of CDMO sites, GMP analytical testing laboratories, and manufacturing support service centers across the United States. Our experienced, highly trained industry experts, and our investment in state-of-the-art development and manufacturing facilities emphasizes our commitment to efficiently advancing client programs through the clinic to commercialization. We are dedicated to delivering the best and most reliable services with positive customer experiences across all channels of our business.

Our Pharmaceutical Development laboratories in Boston, MA, Salem, NH, San Diego, CA, Philadelphia, PA, and Ann Arbor, MI, provide IND-enabling services to help new therapies progress through the pre-clinical stages, to include: Characterization of new synthetic small molecules, biologics such as proteins, peptides, antibodies, antibody drug conjugates, and gene therapies such as oligonucleotides. Early phase development services include lyophilization process development, spray-drying, phase-appropriate analytical development, Test Article preparation, and Clinical Trial Materials (CTM) manufacturing and packaging services.

Technology transfer to our state-of-the art GMP testing facilities enables our clients to seamlessly and confidently advance their programs from preclinical and clinical studies to commercialization in a manner compliant with regulations and industry standards. Strategic partnering with Pace^® is a key accelerator for getting your products to market on time and on budget. We provide a real and tangible difference to your customer experience by combining all essential service elements:

Comprehensive Scope of Services: A broad scope of services to support you from early characterization and Pharmaceutical Development through marketed product support.

Pharmaceutical Development

• Characterization of Novel Molecules & Biologics
• Solid State and API Characterization
• Formulation Development
  -Long-Acting Injectables
  -Lyophilization
  -Hot-Melt Extrusion
  -Spray Drying
• Clinical Supplies Manufacture (Sterile & Non-Sterile Capabilities)
  -Sterile Aqueous Products
  -Ophthalmic
  -Tablets/Capsules
  -Solutions, Suspensions, Ointments, Creams Clinical Packaging

Analytical Method Development

GMP Laboratory Testing

• Raw Materials Clearance Programs
• Methods Development & Validation
• In-process & Finished Product Testing
• ICH Stability Programs
• Reference Standards Programs
• Extractables/Leachables
• Elemental Impurities
• Physical-functional Testing
• Microbiology Testing Services
• Commercial Product Support

Facility Services

• Facility Commissioning & Qualification
• Critical Utility Qualification
• Equipment Services
• Laboratory Relocations

Consulting Services

• Regulatory Strategy & Agency Support
• Quality & Compliance Consulting

Capacity: Pace^® is committed to providing services to all clients, large or small. Our flexible response to demand provides various service models to include fee-for-services, dedicated resource programs, full-time equivalent (FTE) model on-site at Pace^®, and/or FTE programs at the client site, which allow for economical options to meet business demands.

Quality: Our facilities have long histories of successful regulatory agency, client, and third-party audits. High-quality data and information provides the confidence you need to advance your products quickly.

Reliability: Our integrated services ensure critical path demands stay on schedule.