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ChromaCon Process Development Services

 

ChromaCon offers modular service packages to help solving customer’s purification challenges by using Contichrom®. We offer partial or full process development services, including the direct comparison between batch process performance and the performance of our novel processes. We can also model scale-up scenarios including CAPEX and OPEX savings. We also help to enable customers to develop their process in their own laboratories with the help of on-site training on Contichrom® rental units. We support customers, if needed, through interactive Webinars and navigation help through remote-control access to the ChromIQ® operating software.

 

A typical customer process development pathway at ChromaCon for MCSGP is outlined below. Similar process development can be done with CaptureSMB® or combined processes involving both process principles.

Work package 1: Feasibility study (4 weeks)

  • Transfer of documents and materials from customer to ChromaCon
  • Verification of methods at ChromaCon.
  • Verification of preparative batch chromatography step at small scale
  • Repetition of the preparative batch chromatographic method, but instead of feed material, side-fractions are loaded.
  • Estimation of performance improvements (yield, productivity) by the use of MCSGP.

Milestones WP1:

  • Verification of preparative batch chromatography step at ChromaCon shows comparable results with respect to yield, purity and chromatograms (preparative and analytical).
  • Potential for performance improvements (yield, productivity) by MCSGP modeled.

Work package 2: MCSGP process development (6-8weeks)

  • Adaptation of batch chromatographic method in order to make it suitable to design initial MCSGP operating conditions (MCSGP design batch) by variation of column load and gradient shape.
  • Design MCSGP operating conditions from MCSGP design batch using ChromaCon’s software tools.
  • Run MCSGP experiment with the initial operating conditions to verify model.

Milestones WP2:

  • MCSGP experiments provide a process with an at least as good yield as in batch chromatography (at comparable productivities and within product specifications).
  • Transfer of work package 2 report (slides) to customer.

Work package 3: MCSGP optimization (6-8 weeks)

  • Operate MCSGP at 5 different optimized operating points in order to maximize yield.
  • Operate the optimal MCSGP experiment for 12-24hrs to prove process stability, collect samples from the four MCSGP outlets, analyze samples, evaluate purities.

Milestones WP3:

  • MCSGP experiments provide an optimized process with a significantly better yield as in batch chromatography (at comparable productivities and with product in specifications).
  • Transfer of work package 3 report (slides) and additional documentation to customer.

For obtaining more information or requesting a quote please refer to:  sales@iss-gb.co.uk

 


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