Contract Manufacturing

With the acquisition of Serologicals in 2006, Millipore gained 20 years of experience in antibody, reagent and IVD kit manufacturing and combined it with a full range of custom and contract manufacturing services for the diagnostic manufacturer.

Our quality systems and understanding of the regulatory landscape ensures that your product meets required standards.

Why Outsource?

Outsourcing to Millipore helps you achieve sales goals faster and accelerate technology transfers into routine manufacturing. Leveraging our core competencies keeps your human resource expenses low.

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.

Services

Cell Line Development and Optimization	Monoclonal Antibodies
Serum-free adaptation for improved yields and ease of purification cGMP cell banking and inventory management	Development and 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 – 5000 L
Polyclonal Antibodies	Protein Expression
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	E. coli Insect cells Protein production in static, roller, airlift, Wave and stirred systems. Fermentation volumes from 1 L – 100 L
Purification	Conjugation: Antibodies and Proteins
Protein A or G Ammonium sulphate Affinity Client dedicated columns Ion Exchange Hydrophobic Interaction Chromatography (HIC) Size Exclusion	FITC Rhodamine DTAF Cy3 Biotin Cy5 Peroxidase Photoproteins Alkaline Phosphatase Alexa Fluor®
Custom	Filling and Packaging
Formulation of bulk reagents Blocking reagents for interfering antibodies Functional and purity assays to your specifications	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 – 20 L Flexible primary packaging and kit formatting

Capabilities

• Project and production management of multiple products and cell lines
• 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 A MILLIPORE EXPERT

Email: livingston_customer_services@millipore.com
Phone: +44 1506 404000