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GeneXpress Services

GeneXpress is our protein production service, designed to meet the development and clinical needs of biotechnology, pharmaceutical, vaccine and diagnostic companies. We also develop and manufacture high quality research materials to assist scientists in the creation of vaccines against influenza, cancer, HIV/AIDS, SARS and other emerging diseases. In all cases, we utilize our proprietary BEVS technology to generate high quality recombinant proteins suitable for research, clinical evaluation and commercialization.

GeneXpress programs are tailored to the individual project needs and allow customers to leverage our qualified platform and regulatory experience. Programs typically occur in three phases:

Phase I: Cloning & Expression
  • Creation of recombinant baculoviruses
  • Feasibility study
Phase II: Process Development
  • Determination of the optimal fermentation conditions for product yield and quality
  • Development of purification and qualification processes at two different production levels
  • Manufacture of cGLP material for research and preclinical studies
Phase III: cGMP Manufacturing
  • Transfer of the production process to our manufacturing facility
  • Manufacture of cGMP material (10L, 45L or 450L scale) for clinical development and/or commercialization
  • Formulate and fill up to 1200 vials of clinical material per day
  • Regulatory support
  • Commercial manufacturing or technology transfer to the customer's desired manufacturing facility
For more information, please contact Daniel Adams, Executive Chairman and Global Head of Business Development, at 1-203-686-0800 x303.

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Experience

We have been using our BEVS technology platform since 1983, making us by far the most experienced in the field. We have produced more than 1,000 different proteins, all of which have been correctly folded and biologically active, and have extensive experience in manufacturing clinical products under current Good Manufacturing Practices (cGMP) as set by the U.S. FDA and other regulatory authorities. Moreover, our products have an outstanding safety record in both human and animal clinical trials.

cGMP & Regulatory Expertise

  • Over 15 years experience manufacturing cGMP products
  • Produced more than 50,000 doses of vaccine in our pilot plant
More than 40 Phase I-III human clinical trials conducted with materials manufactured by us

More than 10 Investigational New Drug (IND) applications and two Biologics License Applications (BLAs) submitted and accepted by the FDA

Received FDA approval for Flublok influenza vaccine in January 2013

Excellent safety record
  • More than 5,000 healthy and HIV-infected adults and children participated in our HIV/AIDS, malaria, influenza and cancer vaccine clinical trials
  • Clinical follow-up of up to five years in healthy subjects and over seven years in HIV-infected individuals
  • No significant safety-related incidents related to our products reported in any clinical trial
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GeneXpress
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