Are you “nearly” ready for manufacturing?

If scale-up and validation are needed, Maxim Biomedical can apply its extensive expertise and experience with bench to production scale-up and validation of both your process and product. If you require manufacturing services, we want to talk with you about why manufacturing at Maxim Biomedical is the smart choice. Contact our customer service department today for more information.

SERVICES

Assay Development

Maxim can help clients in all stages of development of assays from various sample sources. Our staff are highly experienced in assay optimization and providing our clients will results they need.

Customer Service

Maxim is dedicated to providing all customers will the highest quality of customer service and attention. Maxim works with all of clients individually to establish and exceed their quality requirements.

Contract Research/ Contract Manufacturing (CRO/CMO)

Maxim’s CRO/CMO Services can assist clients in the development of assays or can provide high volume manufacturing of existing products for validations, clinical trials, or market sales.

 

TOP FACILITY

Maxim Biomedical, Inc.

Maxim Biomedical operates a 30,000 sq. ft. cGMP and ISO 13485 certified facility which is equipped to meet OEM manufacturing needs for the pharmaceutical and in vitro diagnostic product industry.

  • Multiple clean rooms class from 100 (ISO 5) to 10,000 (ISO 7) are available for:
    • Buffer preparation (capacity to >1,000 Liters per lot production)
    • EIA plate coating
    • Western Blotting
    • RIBA
    • Lateral Flow Immunoassay (LFI)
    • Class 100 clean room is used for automated aseptic filling range from 0.5ml to 1,000 ml per vial/ bottle
  • Multiple dry rooms with total 1,000 ft2 and LFI supporting of 600 ft2 areas
    • Three of multiple lines, up to 8 lines immunostrippers
    • Multiple units of Laminators
    • Multiple units of Guillotine cutters
    • Multiple units of strip pouch and plate pouch sealer
  • Microtiter plate/ Bead coating and pouching equipment
    • Large scale processing 1200 plates/hr with accuracy of ± 5% CV
    • Computer controlled ultrasonic fill verification system of each well
    • Two fill stations (fill 96/384 wells simultaneously) and three aspiration stations with final aspiration < 2µl residual moisture
    • Two small scale processing 600 plates/hr with accuracy of ± 5% CV
    • Multiple beads coating for multiplexing immunoassay or chemiluminescence assay
  • BSL level-3 facility with
    • Walk-in 27˚C to 38˚C warm room and capacity of 2L x 1000 roller bottle.
    • Six high speed and ultra-speed centrifuges for processing of virus
    • Cell culture with 8 biological safety cabinets

  • Automatic Packaging and Labeling System

Our broad spectrum of process capability and in-house expertise translates into expanded client services. To compliment kit manufacturing, we also provide:

  • Recombinant antigen production (E.coli, Baculovirus and Mammalian Systems)
  • Virus production (BSL level 3)
  • Mono- and poly- antibody production, purification and labeling
  • Formulations of reagents and controls
  • Assay development, ELISA/ CLIA, WB, RIBA, Lateral Flow Immunoassay (LFI), and MDx-qPCR, etc.

QUALITY SYSTEM

At Maxim Biomedical we are committed to providing high quality immunoreagents to organizations involved in the in vitro diagnostic market. Our broad spectrum of process and packaging capability translates into expanded customer services.

Our FDA cGMP approved facility combined with our dedicated, professional staff and proven quality assurance systems ensures production which measure up to the highest standards and complies with cGMP guidelines. Maxim's quality system is also ISO 13485 certified.

TAILORED PACKAGING

Maxim’s ability to match each unique set of packaging conditions is derived from our operational strengths in the following key areas:

Maxim works closely with companies ranging in sizes from technology enterprises to major international corporations. For clients with a validated process, Maxim provides manufactured products in strict accordance to customer specifications. Our fully cGMP plant combined with dedicated, professional staff and proven quality assurance systems ensures production which measures up to the highest standards.