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)

PHARMACEUTICAL GMP LABORATORY TESTING (CRO)


SUPPORTING PHARMA-BIOLOGICS INNOVATION WORLDWIDE
Pace Analytical Life Sciences (PLS) is a premier contract development & manufacturing (CDMO) and contract research (CRO) organization helping to improve human health by supporting the Pharmaceutical, Biologics, and Gene Therapy innovators. We help to bring new therapies to market starting with early-phase drug development through successful clinical outcomes and on through commercialization and late-phase manufacturing. We share a common goal to bring real value to people, healthcare professionals and health businesses around the world.

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 Pace Life Sciences’ 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 Analytical 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:

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

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

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 PLS, 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: We integrate all critical path components to ensure that programs advance while meeting rigorous scientific demands with flexibility to address dynamic challenges and aggressive timelines.