About Repligen Bioprocessing
For over 20 years Repligen's products have played a central role in the successful development and commercial production of biotherapeutic and diagnostic antibodies. Repligen's commitment to quality, depth of technical knowledge and track record for reliability make us the ideal partner to help meet the challenges facing the industry as it strives for biotherapeutic manufacturing industrialization. Repligen is leveraging its knowledge and expertise to provide new products that will enable more efficient, optimized and cost effective processes. Repligen's Bioprocessing business is estimated to record approximately $15 million of product revenue in fiscal year 2011 (ended March 31, 2011).
With over two decades as a critical supplier, Repligen Bioprocessing continues to demonstrate the following four highly valued attributes that ensure leadership and partnership:
Reliability
Recombinant Protein A chromatography ligands manufactured by Repligen are used in the manufacture of over half the world's approved monoclonal antibody therapeutics
Repligen supplies R&D and commercial scale recombinant Protein A and affinity chromatography resins to world-class partners and customers. As a supplier of such critical process materials, it is important that our products meet a high level of consistency in terms of both quality and security of supply. In order to ensure continued compliance with these standards Repligen has implemented formalized auditable programs:
- ISO 9001:2008 certification. Repligen manufactures its [bioprocessing] products under a formal quality system designed to emphasize process control, traceability, and product conformance. Repligen practices continual improvement initiatives based on routine internal audits, customer feedback and audits performed by our partners and customers.
- A Business Continuity Management System. Repligen's management system focuses on key measures such as contingency planning, security stocks and off-site storage of raw materials and finished goods to ensure continuous supply of our products.
Expertise
Repligen is among the world's top commercial protein manufacturers with over 20 years of experience and a capacity exceeding 100kg annually
Repligen's [100kg-plus] production capacity defines us as a major manufacturer of commercial recombinant proteins and has provided us with extensive experience in process development, fermentation and downstream processing. From R&D to manufacturing we develop and manufacture recombinant proteins for ourselves and contract OEM clients and have routinely demonstrated a high level of manufacturing competence including technology transfer, scale up, process validation and quality assurance. Our expertise in the optimization of E. coli fermentation and purification processes combined with our ISO9001 quality system has resulted in the development and implementation of cost effective production processes that produce recombinant proteins of the highest quality.
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Capability
Repligen is building on its world leadership position in recombinant Protein A to offer high performance, cost competitive products for protein purification.
Repligen is providing products that can make a difference. We focus on product development and commercialization in several critical areas including:
- Cost Effective Protein A resins: Repligen has leveraged its unique position as a world leader in recombinant Protein A production to offer cost competitive Protein A resins for development, clinical and commercial scale manufacturing applications.
Our resins meet or exceed expected regulatory and quality standards and are:
- Supported by Regulatory Support Files
- Manufactured using materials with acceptable safety profiles
- Used in the purification processes of several commercial therapeutic and diagnostic products in the USA and Europe
Repligen's Protein A resins combine high quality and high performance with low cost of ownership providing a capture purification solution for mAbs with a compelling value proposition. This resin is an ideal candidate for clinical and commercial processes as well as processes developed with single use technologies or limited campaign practices in mind. Find out More
- Bioprocess development and monitoring tools: As the original pioneer in recombinant Protein A, Repligen first recognized the need for a “ready to use” ELISA kit for leached Protein A. CMOs and biopharmceutical companies of all sizes benefit from our sensitive, accurate and reliable kits that minimizes assay development, training and testing time. Repligen currently offers two distinct kits, one for the detection of leached [native] and recombinant Protein A and the other for the detection of GEHC's MabSelect SuRe™ ligand. Repligen supplies the only commercially available ELISA kit to offer a MabSelect SuRe™ standard which ensures the greatest test accuracy is achieved. Find out more
- Opus™ Pre-packed Chromatography Columns: Repligen's innovative Opus™ Pre-Packed Chromatography Columns offer a range of columns packed with standard or custom resins. Opus™ columns will help the industry meet reductions in cost of goods and implement single or limited campaign use chromatography. For clinical or commercial manufacturing from monoclonals to vaccines, Opus™ columns offer customers the convenience and consistency of pre-packed columns, especially with difficult to pack resins. Opus™ is an "open platform" technology and will work with most commercially available resins. Find out more
Innovation
Repligen has combined “adaptive evolution” of existing technologies with innovation to deliver practical yet economical bioprocessing solutions. Our past achievements are being matched by newer product developments…
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Our innovative achievements include:
- rProtein A: Repligen identified and cloned the gene to express recombinant Protein A in E. coli. Today rProtein A is a critical tool used to purify over half of the world's therapeutic monoclonal antibodies. rProtein A is preferred over the native protein which is expressed in the pathogenic Staphylococcus aureus organism. Repligen has also developed other Protein A based ligands that provide increased relevance to the industry such as rSPA (recombinant native Staph Protein A), an exact amino acid for amino acid copy of the native Protein A. rSPA provides easy conversion from the much harder to work with native ligand. Find out more
- As a pioneer in the field of Protein A capture, Repligen offers a superior quality “off the shelf” ELISA kit for the detection of leached Protein A which is mandated for the release of therapeutic monoclonal antibodies. The test requires extreme sensitivity, high level of detection and precision to ensure the amount of leached Protein A in any dose is within specification. Repligen's ELISA kit demonstrates ease of use and a high level of sensitivity and reproducibility even in complex matrices. The advent of the GEHC MabSelect Sure™* ligand gave Repligen a chance to innovate again developing and launching a superior quality ready to use ELISA kit for this new ligand. Find out more
- Repligen's innovative Opus™ Pre-Packed Chromatography Column offers a range of columns packed with standard or custom resins. This innovation brings the promise of single or limited campaign use chromatography to reality. For clinical or commercial manufacturing from monoclonals to vaccines, the Opus™ columns offer advances in consistency, convenience, product safety and simple economics. Even in traditional processes the use of these columns is applicable for customers who prefer the ease and consistency of "plug-n-play" pre-packed columns, especially with difficult to pack resins. Find out more
*MabSelect SuRe™ is a trademark of GE Healthcare