Featured Business

Sigma-Aldrich | SAFC Cleveland

4353 East 49th Street, Cuyahoga Heights, Ohio 44125
Toll-Free 800-321-0570 | Technical Service 800-334-0144
www.sigmaaldrich.com 

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SAFC Center of Excellence

SAFC Cleveland is SAFC’s Center of Excellence for biological buffers, cell culture media components and reagent compound manufacturing used in the biopharmaceutical and diagnostic industries. This chemical production facility consists of laboratory, intermediate and bulk chemical areas capable of producing a broad range of batch sizes, quality control laboratories and dedicated packaging facilities operated under ISO9001 and cGMP IPEC guidelines.

Core Technologies

  • Bulk scale chemical processing equipment is a multi-use, multi-vessel set up with equipment redundancy
  • Pilot and laboratory-scale chemical synthesis capabilities
  • Dedicated and segregated packing facilities
  • Fully equipped and staffed QC department for testing products and raw materials
  • Molecular biology laboratory for chemical testing

Core Competencies

  • Biological buffers • Amino acids, derivatives and peptides • Cell culture components
  • Diagnostic reagent components
  • Pack sizes up to 125 kg
  • Batch sizes up to 3,000 kg
  • Chemicals produced have a long history of successful use as components in biopharmaceuticals, cell culture media, diagnostic reagents, life science research and specialty chemical markets

Capabilities/Equipment Overview

  • Provide responsive customer service and unsurpassed quality in our products
  • Multi-scale, robust chemical processes that produce high quality, reproducible biological buffers and biochemical reagents that exhibit high clarity, superior solubility and minimal trace metal content, with lot-to-lot consistency
  • All processes use non-animal derived raw materials
  • Full lot traceability in manufacturing and the supply chain
  • Chemical-based processes provide material that is inherently low in bio-burden and endotoxin contaminants
  • Custom services for chemical synthesis, formulation, packaging and analytical/MB testing
  • Processing equipment in Manufacturing Facility is a multi-use, multi-vessel set up with equipment redundancy and vessel sizes ranging from 30-2,000 gallons

About SAFC

SAFC is a trusted manufacturer of specialty chemicals and biologics for commercial life science applications. We provide unique and innovative technologies and services for customers requiring a reliable partner throughout the development and manufacturing process.

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Biopharmaceutical Expression Systems

SAFC offers multiple levels of support for your biopharmaceutical expression systems needs with a focus on increasing production titer and decreasing development timelines. In addition to our long history of reliability in supplying high grade critical raw materials, our offerings are backed by top notch technical support by Ph.D. level scientists and comprehensive protocols for ease of use. Decrease your time to market and costs by leveraging the CHOZN manufacturing system.

http://www.sigmaaldrich.com/safc/biological-manufacturing.html

Bioprocess Products & Services

SAFC offers multiple levels of support for your biopharmaceutical expression systems needs with a focus on increasing production titer and decreasing development timelines. In addition to our long history of reliability in supplying high grade critical raw materials, our offerings are backed by top notch technical support by Ph.D. level scientists and comprehensive protocols for ease of use. Decrease your time to market and costs by leveraging the CHOZN manufacturing system.

http://www.sigmaaldrich.com/safc/bioprocess.html

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Biosimilar Products & Services

Get there first. In the push to market, the biosimilar that’s approved first wins the race. That’s why SAFC offers CHOZN®, an off-the-shelf,and customizable platform proven to accelerate cell line development timelines by 8 weeks. The CHOZN platform seamlessly integrates with EX-CELL® Advanced™ cell culture media and feeds, and EX-CELL® Glycosylation Adjust (Gal+), a protein quality supplement that jumpstarts profile matching. In a competition where everyone is the same, the only thing that matters more than speed is expertise. See how the experts at SAFC can help you win the race to market.

http://www.sigmaaldrich.com/safc/biosimilars.html

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Contract Manufacturing Services & Solutions

SAFC is a complete pipeline partner for pharmaceutical and biopharmaceutical companies developing and commercializing complex small-molecule APIs and biologic drug substances. The company combines world-class, “single point of contact” project management with proven processes and procedures and offers analytical and process development support at all stages of drug development and manufacture.

http://www.sigmaaldrich.com/safc/contract-manufacturing-services-and-solutions.html

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Testing & Support Services

SAFC is a complete pipeline partner for pharmaceutical and biopharmaceutical companies developing and commercializing complex small-molecule APIs and biologic drug substances. The company combines world-class, “single point of contact” project management with proven processes and procedures and offers analytical and process development support at all stages of drug development and manufacture.

http://www.sigmaaldrich.com/safc/testing-and-support-services.html

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Quality & Regulatory Support

SAFC has multiple cGMP manufacturing locations worldwide for biochemical production and manufacturing of complex organic APIs and key intermediates. Therefore, SAFC must meet many different regulatory requirements globally. Our Quality Systems are designed to meet stringent regulatory requirements, but flexible enough for us to customize many specific items for your needs.

http://www.sigmaaldrich.com/safc/quality-and-regulatory-support.html

Global Project Management  – Commercial

SAFC is dedicated to providing quality project management to our clients. Each project is unique in terms of scope and challenge, which are dependent upon your unique development and manufacturing requirements. However, we have found that a systematic approach using best practices across all of our worldwide locations is key to exceeding customer expectations. SAFC uses a single-point of contact project management approach that fosters an environment of collaboration, communication and flexibility. The Project Manager is responsible for driving the project to completion professionally; on-time with the quality and quantity the client expects. SAFC’s project managers facilitate the timely communication of important technical information and production timelines.

http://www.sigmaaldrich.com/safc/project-management.html

Sourcing Services | CHESS™ Program

Let your development chemists concentrate on the development of new products, not the search for raw materials. Allow your purchasing group to streamline the multiple and ever-changing requests for raw materials and intermediates. Let SAFC develop a single-partner, customized sourcing program designed specifically to fit your needs.

http://www.sigmaaldrich.com/safc/sourcing-services.html

Clinical Trial Laboratory Services

Clinical trials for biological products may require additional tests beyond the standard clinical chemistry and hematology. Many of these analyses involve the development of specialized assays that are not routinely performed by most Clinical Research Organizations or Reference Labs. To complement our significant experience in the testing of biological therapeutics, SAFC, through its BioReliance business, offers these assays as part of its Clinical Trial Laboratory Services. All assays are performed according to the principles of GLP.

http://www.sigmaaldrich.com/safc/clinical-trial-laboratory-services.html