requests-for-proposal

Seeking A Process to Concentrate an Enveloped Virus

Request Number REQ8364429
Due Date February 1, 2018
Request for Proposal Details
Additional Points of Contact
RFP Title
Seeking A Process to Concentrate an Enveloped Virus
RFP Description

NineSigma, representing a global pharmaceutical manufacturer invites proposals for processes, manufacturing techniques, methodologies or other advances in microbiology to enable enveloped virus concentration.

Background

Viral antigens are typically manufactured in bio-fermentation reactors from large volumes (up to 1000L) containing high concentrations of mammalian cells. During the processing and isolation of the virus, significant cell detritus (RNA, DNA, proteins etc) are produced in the supernatant, which ideally needs to be removed and the broth concentrated to enable cost effective viral loads to be produced.

 

In the current challenge, Ninesigma's client is producing a virus with a global neutral charge which is problematic to filter using ion exchange chromatographic techniques. Standard proven success technologies such as chromatographic columns or tangential flow filtration can’t be used because of the inherent cost. The client is looking for an alternative method / technique or process to concentrate the virus particles which does not require expensive CAPEX.

 

The virus of interest has a core diameter of 20-30nm surrounded by a lipid containing envelope of 45-60nm. This outer layer yields a net neutral charge.

 

The client is open to all ideas and especially keen to learn more from food and drink industry, agriculture or other microbiology industries. Additionally, novel fluidic devices which require development are also welcomed.

 

Anticipated Project Phases or Project Plan

Phase 1 – Proposal review

Review of technology and other project experience / applications.

 

Phase 2 – Proof of concept testing

Identification of costs required to develop proposed technology for specific application.

 

 

Criteria for Moving from Phase 1 to Phase 2

Successful demonstration of technology and proof of previous experience.

 

Key Success Criteria

The successful technology / process will meet the following criteria:

 

  • Increase viral concentration from 108 to 109 particles per mL
  • Maintain a cost of <$5000 per batch
  • Process batches of 500L to 1000L
  • Be compatible with a net neutral charge on the virus
  • Ideally involve simple, automated steps requiring minimal expert intervention
  • Work at <50°C
  • Maintain broth pH between 6.5-7.5.
  • Ideally filter out waste mammalian cell culture from concentration process (not essential)
  • Technology should be compatible with an antigen / oily excipient target
  • Suitable for Parenteral injection

 

Possible Approaches

Possible approaches might include, but are not limited to:

 

  • Any process which meets the concentration target
  • Viral / Bacterial / microbial fermentation filters
  • Heparin affinity
  • Differential precipitation
  • Ultrafiltration (simple non-expensive developments)
  • Disposable discs, microfluidics
  • New developments from food processing / textile or dyes industry
  • Vaccine immune-stimulants
  • New surfactant chemistries

 

Approaches not of interest

The following approaches are not of interest:

 

  • Toxic materials which cannot be removed
  • Expensive columns / Tangential flow filtration technologies
  • Ion exchange based technologies

 

Preferred Collaboration types
  • Joint Development
  • Technology Licensing
  • Technology Acquisition
  • Supply Agreement
Items to be submitted

To respond to this challenge, please complete the following survey LINK

 

For assistance, please contact the Programme Manager (worsfold@ninesigma.com).

 

 

Non-Confidential Disclosure

By submitting a response, you represent that the response does not and will not be deemed to contain any confidential information of any kind whatsoever.

Area of Interest
  • Packaging
Request Priority
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