Contract Manufacturing Services

 

Contract Manufacturing Services

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With the consolidation of two great companies, EMD Millipore 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. EMD Millipore 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 EMD Millipore 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 EMD Millipore today to secure your organization’s performance tomorrow.


Services & Capabilities

Services
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
Protein Expression
  • E. coli
  • Insect cells
  • Protein production in static, roller, airlift, WAVE™ and stirred systems
  • Fermentation volumes from 1 L – 100 L
Conjugation: Antibodies and Proteins
  • FITC
  • Rhodamine
  • DTAF
  • Biotin
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
Cell Line Optimization and Storage
  • Serum-free adaptation for improved yields and ease of purification
  • cGMP cell banking and inventory management
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
Purification
  • Protein A or G
  • Ammonium sulphate
  • Affinity
  • Client dedicated columns
  • Ion Exchange
  • Hydrophobic Interaction Chromatography (HIC)
  • Size Exclusion
Custom
  • Formulation of bulk reagents
  • Blocking reagents for interfering antibodies
  • Functional and purity assays to your specifications
  • Peroxidase
  • Photoproteins
  • Alkaline Phosphatase

Capabilities
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

Consult an Expert

Contact EMD Millipore to learn more about our contract manufacturing capabilities or to discuss your specific raw material, intermediate, and finished diagnostic product needs.

Fill out this form to receive a 10% discount on your first service contract!

(Discount is valid on all services initiated between October 1 and December 31, 2014.  Not valid on any existing service agreement or for services already quoted.) 
 
 

Events

Nov 12
11/12/14 - 11/15/14
Medica Seminar
Düsseldorf Trade Fair Centre (Messe)
Düsseldorf, Germany
IVD/OEM Materials and Reagents Europe 20141112