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 from ISO 5 to ISO 7 are available for:

    • Molecular Diagnostics (Molecular Dx): Multiplex Real-Time qPCR, Isothermal Amplification
    • Lateral Flow Immunoassay (LFI)
    • Western Blotting (Custom Bulk WB Production)
    • RIBA (Recombinant ImmunoBlot Assay, Line Assay)
    • EIA Plate Coating (2X 400 plates/hr to 1X 1,200 plates/ hr capacity)
    • Buffer Preparation (400 L, 500 L, 1,000 Liters capacity per lot production)
    • Class 100 clean room is used for automated aseptic filling range from 0.5ml to 1,000ml per vial/ bottle
      Multiple dry rooms with total 1,000 ft2 and LFI production supporting of 600 ft2 areas

      • Five of multiple lines, up to 8 lines immunostripers
      • Multiple units of Laminators
    • Multiple units of Guillotine cutters
    • Multiple units of strip, cassette pouch and EIA plate pouch sealer
    • Dry rooms can be controlled down to <10% relative humidity
    • Temperature and humidity controlled incubator and walk-in incubators
    Microtiter plate/ bead coating and pouching equipment

    • Large scale processing 1,200 plates/hr with accuracy of ± 5% CV
    • Two small scale processing 800 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
    • Multiple beads coating for multiplexing immunoassay or chemiluminescence assay
    BSL level-3 facility with

    • 2L roller bottle with 1,000 units’ capacity in a 27˚C to 38˚C walk-in warm room
    • Six high speed and ultra-speed centrifuges for processing and purification of virus
    • Large capacity CO2 incubators
    • Cell culture with 8 biological safety cabinets
      Automatic Labeling and Packaging System

    • Numerous sizes of labels suitable for room temperature, 2-8°C and -20°C
    • Various printers for different conditions of printing, laser, dot matrix, heat transfer, etc.
    • Automatic labeler for pouches and boxes labeling


OUR BROAD SPECTRUM OF PROCESS CAPABILITY AND IN-HOUSE EXPERTISE TRANSLATES INTO EXPANDED CLIENT SERVICES. TO COMPLIMENT KIT MANUFACTURING, WE ALSO PROVIDE:

      Raw Materials Research, Development and Production

    • Recombinant antigen production (E. coli, Baculoviral and Mammalian Systems)
    • Virus production (BSL level 3)
    • Mono- and poly- antibody production, purification and labeling
      Formulation and Assay Development

    • Formulations of reagents and controls
    • Assay Development/ Technical Transfer
      • MDx-Real-Time qPCR (CT/NG; HSV1/2/VZV; HPV, etc.)
      • MDx- Isothermal Amplification (CT/NG; HSV1/2/VZV; HPV, etc.)
      • MDx- Generic Assay Detection (Biotin/ Dig; Biotin/ FAM; Biotin/ FITC, etc.)
      • LFI- Infectious Diseases (HIV1/2- Whole Blood, Serum/ Plasma, Oral Fluid; H. pylori- Ab, Whole Blood, Serum/ Plasma; -Ag, Feces, etc.); Steroid- Estradiol, Progesterone, PdG, etc.; Women Health (fFN- Rupture of membrane; NGAL- Preeclampsia; IL-6; MMP-8, etc.); Cardiac Biomarkers (Troponin I, CK-MB, Myoglobin, etc.); Tumor Markers (AFP, PSA, FOB, etc.); and many others…Call for detail.
      • ELISA/ CLIA- HIV-1/2 serum/ plasma, oral fluid, urine; HIV-1 p24 capture assay; H. pylori Ag and Ab; IGFBP-1; NGAL; IL-6: AFP; PSA; CRP; Troponin I; Lp-PLA2 and many others… Call for detail.
      • WB- HIV-1/2 serum/ plasma/ oral fluid; One of the earliest FDA approved, commercial available WB kit developer; Call for services
      • RIBA- Call for services

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.