Customer Service and Contract manufacturing
Maxim Biomedical is a medical diagnostics company based in Rockville, Maryland, USA. Our vision is to help shape the future of clinical laboratory productivity by manufacturing and distributing quality diagnostic kits for diagnosis of infectious disease and other fields.
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 approve 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.
TOP FACILITY
Maxim Biomedical operates a 27,000 sq. ft. cGMP facility which is equipped to meet OEM manufacturing needs for the diagnostic product industry.
·Class 100 clean room for automated aseptic filling capable to fill range from 0.5ml to 500 ml
·BSL level-3 facility with walking warm room with capacity of 400 roller bottles and temperature range 27˚C
to 38˚C.
·4 high speed ultra centrifuges for processing of virus.
·Cell Culture with 8 biological safety cabinets.
·Microtiterplate Coating equipment processing 1000 plates/hr with the fill accuracy of ± 5% CV.
Computer controlled ultrasonic fill verification system of each well. Two fill station (fill 96/384 wells
simultaneously) and three aspiration stations with final aspiration > 2µl residual moisture.
·Packaging and Labeling
Our broad spectrum of process capability and in-house expertise translates into expanded client services. To complement kit manufacturing, we also provide:
·Recombinant Antigen Production
·Virus production (BSL level 3)
·Antibody production in cell culture
·Formulations of reagents and controls
TAILORED PACKAGING
Maxim’s ability to match each unique set of packaging conditions is derived from our operational strengths in the following key areas:
·High Speed Liquid Filling
·Custom Labeling
·Foil Pouching
·Kit Assembly
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.
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. Please use the following feedback form to contact our customer service department.
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