Life Technologies has a devoted team of AcroMetrix® product experts that specialize in OEM customization to help you achieve your business goals faster and more effectively. OEM customization produces assay kit controls that can be utilized for manufacturing and commercialization strategies for assay manufacturers. A variety of targets and matrices are available for OEM projects and are not restricted to catalog products. These targets and matrices include synthetic target–specific sequences, recombinant vectors containing target-specific inserts, synthetic RNA, and tissue and cell culture materials.

OEM capabilities

OEM capabilities include:

  • Commercialization capabilities allow for global distribution, packaging, and consignment
  • Manufacturing functions include cGMP, filling services, and private labeling
  • Controls for use in clinical trials
  • Controls for use in customer training

Contracts

We recognize that the needs of your business vary. To provide maximum flexibility, we offer several contractual approaches to our custom business that includes:

  • OEM kit control contracts
  • Co-development agreements
  • Co-marketing agreements

Established processes for OEM Solutions

Life Technologies offers contract manufacturing services providing OEM AcroMetrix® products for both nucleic acid and serology testing procedures. Products under this program are manufactured in our state-of-the art manufacturing facilities and depending on the contract can be manufactured according to following systems and registrations:

  • FDA Registered Establishment
  • Device Manufacturing License (CA State)
  • ISO 13485:2003 Certification
  • Compliant with cGMP/cGLP/ QSRs (US), ISO, IVDD, and other regulations (EU)
  • Compliant with ISO 17511:2003

If you are interested in speaking with us about partnership opportunities, beta-products, or our Contract Manufacturing services, please email AcroMetrix-oem@lifetech.com