Vaccines Manufacturing Facilities

n December 2014, we expanded our vaccines capabilities with the acquisition of Kalon Biotherapeutics LLC, based in College Station, Texas, USA, with development and manufacture expertise in viral, pDNA, VLP and recombinant vaccines.

Our team of vaccines experts can assist in the development and scale-up of your product from pre-clinical to commercial production.

Core Competencies

  • Process transfer, development and optimization
  • Analytical development to commercial scale production
  • Implementation of the latest in single-use and viral vaccine technologies

Process Development Equipment

  • Cell growth and harvest:
    1. CO2 incubators, DASGIP 1L reactors, 10L XDR mammalian reactors
    2. 50L XDR, 200L XDR (microbial and mammalian)
  • Multiple AKTAProcess, Uniflux, Sartoflow
  • 3006 GAE Niro homogenizer

Innovative Manufacturing Approach

Utilization of Mobile Clean Rooms (MCRs) enables us to provide our customers the highest degree of manufacturing flexibility and biosafety containment. This manufacturing concept allows us to customize and implement client configurable processes for successful clinical and commercial supply.

Capabilities

  • Multiple small scale up to 500L bioreactors and fermenters in clinical development
  • Multiple 1000L to 2000L single-use bioreactors
  • Hollow Fiber and Stack Cell Culture Systems
  • Chromatography, Tangential flow filtration, microfiltration
  • Clinical formulation/fill-finish
  • Ultracentrifugation, bottle and disc stack centrifugation
  • Up to BSL-2 containment levels

Facility Capacity

The current facility has approximately 104,000sq.ft of manufacturing space. Additional facilities are currently under construction to expand our capabilities including:

  • Late phase/commercial facility with BSL-2+ containment expected on-line in 2016
  • BSL-3 containment facility expected on-line in 2016
  • The two new facilities will add approximately 100,000 sq.ft of operating space.

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