Supporting the development and commercialization of your Diagnostic Assays and Components
Advancing Diagnostics Together
Your development and production needs are urgent, and speed to market is a critical component of your commercialization success. You need a strategic partner to work collaboratively with you who understands the importance of quality, efficiency and consistent communication along the way.​
MP Biomedicals would be thrilled to have the opportunity to join you on this journey! We offer a full range of raw materials and custom services to support the development and manufacturing of your IVD assays and components. With over 50 years of experience in diagnostic manufacturing, MP Bio understands the importance of uncompromised quality, efficient solutions and continuous collaboration to ensure you achieve your goals!
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We're here to help answer ny questions you may have. We look forward to hearing from you.
Custom Services tailored to your manufacturing needs
Raw Materials & Formulations
At MP Bio, we formulate custom buffers and reagents according to your instructions and specifications, all following our Tech Transfer process. If you need sourcing support for any of the raw materials, we’ve got you covered with our extensive offering of chemicals and biochemicals. All manufacturing is done in our FDA cGMP compliant facility. We work together closely with you to ensure every step of the process meets your requirements, and the finished product is exactly what you were hoping for.
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Related Customer Success Stories
Custom Reagents
Are you looking for a raw material with certain specifications to meet your manufacturing needs? Would you like a reagent to come in a specific pack size to fit easily into your production process and avoid weighing and storage of partially used raw materials? Our Sourcing and Manufacturing experts can help provide the exact raw materials you are looking for to help improve the efficiency and output of your manufacturing.
Related Customer Success Stories
- How We Identified an Ideal Lot of DSS to Address Variability in Pre-clinical Drug Development Through Data Sharing
- How We Created Extra Production Capacity and Increased Employee Safety by Providing a Ready-to-use Peracetic Acid Option
- How We Eliminated the Need for Costly Infrastructure and Vastly Reduced Speed to Market by Providing an Outsourced, Custom Manufacturing Solution
Custom Kitting
Whether you need support for production of individual components, or full kit assembly for your diagnostic assay, MP Bio can help. Our Kit Assembly experts have the experience, resources and capacity to help produce the batch size you need for either R&D Testing, Clinical Trials, or full-scale Commercialization as you launch your new assay into the market. Our kitting expertise includes custom packaging, label design and documentation support, including inserts and CoA’s. You are focusing your efforts and resources on innovating new technology and developing new assays – let MP Bio help transform your ideas into reality.
Related Customer Success Stories
Fill, Finish, Pack
From small-scale vialing for R&D and Product Development, to mid-scale batches for Clinical Studies, and all the way through to large-scale manufacturing for Commercialization and Product Launch, MP Bio has the capabilities to support you at every step along the way. With automated and semi-automated options, and the option of aseptic processing in our ISO Class VI Cleanrooms, we have the ability to work together with you on your project to ensure consistency and quality with every batch.
Related Customer Success Stories
- How We Created a One-of-a-Kind Solution to Extend Stability and Increase Consistency for Peracetic Acid Lots
- How We Achieved a More Environmentally Sustainable Process, while Freeing up Time, Reducing Storage Capacity, and Minimizing Potential Contamination for Sodium Phosphate Lots
- How We Built Supply Chain Redundancy Using Our Global Supply Chain to Provide Ficin When None Could be Found
Certified Assays
Count on MP Bio's three decades of experience in delivering superior in vitro diagnostic solutions. We offer an extensive range of diagnostic assays, carefully curated for researchers involved in quantifying target molecules and hospitals conducting diagnostic testing. Rest assured, our solutions will provide you with fast and accurate test results you can rely on. With our globe spanning manufacturing and distribution facilities, featuring ISO-certified and FDA-approved labs, we are fully equipped to manufacture customizable tests and assays designed to meet your precise requirements.
