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CHROMATOGRAPHY MEDIA AND COLUMNS FOR USE IN CGMP BIOMANUFACTURING

(contract last updated 04/20/2017)

SCOPE: Contract for the purchase of Chromatography Media and Columns for use in cGMP Biomanufacturing.


CONTRACT # DESCRIPTION
17-5497 CHROMATOGRAPHY MEDIA AND COLUMNS FOR USE IN CGMP BIOMANUFACTURING
CONTRACT ORIGIN: ADDITIONAL INFORMATION:
UW-Madison
Purchasing Services
21 N Park St, Ste 6101
Madison, WI 53715-1218
UW-Madison users contact:
Carla Parker
(608) 262-4516 FAX (608) 262-4467
carla.parker@wisc.edu
  Non-UW-Madison users contact: Vendor Representative
COOPERATIVE PURCHASING:

YES

CONTRACT TERM: April 1, 2017 through March 31, 2018, with automatic renewal extensions to March 31, 2022, unless amended, cancelled or rebid.

Manufacturer: BIA SEPARATIONS
Vendor(s)
137866
BIA Separations Inc
1000 N West St  Ste 1200
Wilmington DE 19801
     
Sales Representative: PHONE # FAX #
Daniela Marc 888-502-4246 302-861-0362
E-mail usorders@monoliths.com
  PHONE # FAX #

Ordering/Expediting:

Daniela Marc

888-502-4246 302-861-0362

Invoice Information:

Jana Krapež Trošt

888-502-4246 302-861-0362

Returns:

Daniela Marc

888-502-4246 302-861-0362

Supplier Diversity Reporting:

Jana Krapež Trošt

888-502-4246 302-861-0362
Website: www.monoliths.com
Commodity Code 175-14
Federal Employee ID # (FEIN) 26-0845199
F.O.B.

“D” F.O.B. DESTINATION

Terms: N/30
Delivery:

8 weeks ARO

Invoicing: Invoices shall reflect contract pricing.
Minimum Order: None
Warranty:

30 days

Return Policy: Contractor will provide for return of items ordered in error for up to 30 calendar days from receipt with the University paying only the return shipping costs.
Pricing Information:

Click here for pricing.

SPECIFICATIONS


PLASMID DNA, PROTEIN-BASED VACCINES, MONOCLONAL ANTIBODY, GROWTH FACTORIES, AND OTHER PROJECTS SUCH AS AAV

 

Waisman Biomanufacturing has between 10 and 20 projects per year that are plasmid DNA, protein-based vaccines, monoclonal antibody, growth factors, and other projects such as AAV.  These require chromatography media and columns. These projects are primarily vaccines and other therapeutics used in phase I/II clinical trials. These products will be used in Waisman Biomanufacturing’s cGMP facility. The cGMP biomanufacturing process uses columns and chromatography media which are changed out for each new project to prevent cross-contamination from other projects. This is critical in adhering to cGMP guidelines for phase I/II clinical trials, as set by the FDA. The department anticipates spending approximately $150,000 annually.

 

1. Chromatography media and resin, including size exclusion (SEC), ion exchange, hydrophobic interaction, and affinity, in bulk and/or pre-packed formats.

 

2. Chromatography columns, valves, and stands.

 

3. Multiple sizes of columns are required for various stages in the project (process development vs. manufacturing) and for different projects based on scale.  Bidder must be able to provide applicable size/formats, with availability of cGMP grade.

 

4. Multiple volumes of media are required for various stages in the project (process development vs. manufacturing) and for different projects based on scale (e.g., 750ml, 1 L, 10L).    Bidder must be able to provide applicable size/formats, with availability of cGMP grade.

 

5. Certificate of analysis is required with each delivery.

 

6. A written description of Bidder’s Quality System and Quality Oversight must be provided with the bid response.


Revision History:

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