Biologics Manufacturing

Biovest cGMP Manufacturing Services

As a leader in hollow fiber technology and with over 2 decades of experience in cell culture, Accentia and partner company Biovest have formulated the optimal strategy for biologics manufacturing.  By accurately matching the level of production technology to the phase of product development, customers can manage their overall investment risk.  Only as products succeed to the next stage of development does BioVest move to a higher-output production environment.

With our focus on both pre-launch therapeutics and marketed diagnostics production, Accentia serves all the manufacturing needs of this customer segment  From process development to regulatory support, our one stop-shop approach provides a solution to customers that have chosen not to build the infrastructure required internally to bring a product to market.

Patented hollow fiber technology is the key to optimizing biologics manufacturing.  For phase I and II cGMP production, Hollow Fiber Bioreactor perfusion technology provides economic advantages through largely automated culture of a relatively large, densely packed population of cells in a small space.  Additionally, the low molecular weight cut-off of the fiber membrane allows more expensive media components to be conserved, while less expensive basal media is continuously perfused through the bioreactor.  As a result, this automated approach is believed to be more cost-effective than conventional methodologies generally used for maintenance of large cell populations. 

If needed, moving to a higher-output production environment for product launch is seamless as we provide all the required regulatory support, including biocompatability studies.

For further information on our contract manufacturing services, please contact us at 1-866-324-6837.

Biovest Contract Services

  • Cell-line Development
  • Media Assessment
  • Cell-line Optimization
  • Cell Bank Creation
  • Process Development
  • Production: GMP & non-GMP
  • Purification: GMP & non-GMP

 

(c) 2005 BioVest International, Inc