With the consolidation of two great companies, MilliporeSigma contains years of experience in antibody, reagent and IVD kit manufacturing and combines it with a full range of custom and contract manufacturing services for the diagnostic manufacturer. MilliporeSigma can provide a global solution for the diagnostic industry, with targeted support and a focus on customer satisfaction.
Our quality systems and understanding of the regulatory landscape ensures that your product meets required standards.
Why Outsource?
Whether you require custom-made solutions or affordable routine protein production, we can help you:
- Meet regulatory compliance
- Lower your capital investment
- Keep costs manageable.
Outsourcing to MilliporeSigma helps you achieve sales goals faster and accelerate technology transfers into routine manufacturing. Leveraging our core competencies keeps your human resource expenses low.
Partner with MilliporeSigma today to secure your organization's performance tomorrow.
OEM Case Study
Outsourcing Security: The need to ensure consistency and continuity of supply in IVD Kit Manufacturing The OEM Project Situation: A well-known IVD kit manufacturer, specializing in immunoassay-based solutions, was facing a serious issue with the production of a critical primary antibody...
Read the study
Services & Capabilities
Services
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| Monoclonal Antibodies |
- In vitro or in vivo production of murine and human hybridomas
- Antibody production in static, roller, airlift, perfusion, WAVE™ and stirred systems
- Fermentation volumes from 1 L – 5,000 L
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| Protein Expression |
- E. coli
- Insect cells
- Protein production in static, roller, airlift, WAVE™ and stirred systems
- Fermentation volumes from 1 L – 100 L
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| Conjugation: Antibodies and Proteins |
- FITC
- Rhodamine
- DTAF
- Biotin
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| Filling and Packaging |
- Dedicated multi-product, class 10,000 clean room able to handle bulk volumes for sterile filtration and dispensing
- Class 100 contained multi-filling systems for container sizes 1 mL – 100L Biocontainers
- Flexible primary packaging and kit formatting
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| Cell Line Optimization and Storage |
- Serum-free adaptation for improved yields and ease of purification
- cGMP cell banking and inventory management
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| Polyclonal Antibodies |
- Antigen development from native, recombinant and synthesized sources
- Goats, sheep, rabbits, mice and other species available
- Standard or custom immunization protocols
- Small to large scale serum processing
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| Purification |
- Protein A or G
- Ammonium sulphate
- Affinity
- Client dedicated columns
- Ion Exchange
- Hydrophobic Interaction Chromatography (HIC)
- Size Exclusion
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| Custom |
- Formulation of bulk reagents
- Blocking reagents for interfering antibodies
- Functional and purity assays to your specifications
- Peroxidase
- Photoproteins
- Alkaline Phosphatase
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Capabilities
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Take advantage of our:
- Project and production management of multiple products and cell lines
- Flexibility in scale and processes
- Dedicated quarantine and development facilities
- Validated disposable technology for production integrity
- Quality and Regulatory Support including:
- FDA CBER Licensed Biologic Facility compliant with FDA 21 CFR 600 and FDA 21 CFR 820
- ISO 9001:2000, ISO 13485:2003, IVD98-79-EC and CMDCAS certifications
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Consult an Expert
Contact MilliporeSigma to learn more about our contract manufacturing capabilities or to discuss your specific raw material, intermediate, and finished diagnostic product needs. Fill out
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