Magazine Article | December 13, 2011

Irvine Scientific

Source: Life Science Leader

2511 Daimler Street
Santa Ana, CA 92705-5588
PH: (800) 437-5706
www.irvinesci.com

 
COMPANY PROFILE

Irvine Scientific is committed to supporting the biopharmaceutical industry in the successful development and commercialization of biopharmaceutical products. As a uniquely focused company, our expertise with media products combined with large-scale production capability, redundant global manufacturing, and elevated regulatory compliance, provides a tremendously valuable resource to biopharmaceutical customers. We demonstrate leadership in:

  • Compliance to highest quality standards
  • Risk-based approach to supply chain management
  • Comprehensive value proposition to the business requirements
  • Proficiency and experience in cell culture media development and production
  • Flexibility and responsiveness to unique requirements

SERVICES
Irvine Scientific is a worldwide leader in the design, manufacture, and distribution of products to the industrial cell culture and assisted reproductive technology (ART) markets as well as critical specialty media to the regenerative medicine market. We provide media and related products to customers in over 75 countries.

We understand the importance of aligning our technology, support, and supply capabilities to meet the distinctive requirements of the industrial cell culture market. Irvine Scientifics’ product and service offering ranges from media and feed formulation development to CGMP manufacture and supply.

Formulation development is a combination of applied experience and a practical, rational approach to media design. Irvine Scientifics’ development team will work with you to provide a sound basis for your development effort.

Media And Feed Formulation

  • Basal and Feed Formulation Development
  • Rapid Media Prototype Samples from Express Media Services Laboratory

                              — Powder 1 to 25KG
                              — Liquid 1 to 200L

Irvine Scientific manufactures CGMP products utilizing integrated systems that ensure continuity of supply, consistent product quality, and delivery within a reliable lead time.

Commercially Available Media Products (Serum-Free and Chemically Defined)

  • IS CHO™ Media and Feed Product Line
  • Protein-free Hydrolysates
  • Insect Cell Culture Media

                               — IS BAC™

  • 293 Cell Culture Media Products

                              — IS GRO™
                              — IS PRO™
                              — IS MAB-CD™
                              — IS 293™

CGMP Manufacturing Capabilities
 

  • Dry Powder Media

                             — Ball and Impact Milling Technologies
                             — Redundant Impact Milling Facilities
                             — Small to Large Scale Lot Sizes

  • Liquid Media

                             — 50 to 10,000 Liter Lot Sizes

  • Water for Injection (WFI)

                             — USP Limits

  • Animal Component-Free Manufacturing
  • Integration of Custom Requirements

                          — Packaging and Labeling

  • Stability and Expiration Studies

Regulatory Support

  • ISO 13485:2003
  • Class II Medical Device Manufacturing Standards