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CELL BANK AND SPECIALIZED MEDICAL AND SCIENTIFIC LABORATORY TESTING SERVICES |
| (contract last updated 09/21/2007) |
| SCOPE:
Contract for the Waisman Clinical Biomanufacturing Facility for specialized medical and scientific laboratory testing services. Primarily, but not exclusively, these are Cell Bank Testing Services. |
|
| CONTRACT # |
DESCRIPTION |
|
08-5035-R1 |
CELL BANK AND SPECIALIZED MEDICAL AND SCIENTIFIC LABORATORY TESTING SERVICES |
| CONTRACT ORIGIN: |
ADDITIONAL INFORMATION: |
UW-Madison
Purchasing Services
21 N Park St, Ste 6101
Madison, WI 53715-1218 |
UW-Madison users contact:
Carl Hubbard
(608) 262-6557 FAX (608) 262-4467
TDD: 608-262-0825
CHubbard@bussvc.wisc.edu |
| |
Non-UW-Madison users contact: Vendor Representative |
| RESTRICTED: |
Restricted to: Waisman Clinical Biomanufacturing Facility |
| COOPERATIVE PURCHASING: |
NO |
| CONTRACT TERM: |
August 1, 2007 through July 31, 2008, with automatic renewal
extensions to July 31, 2010, unless amended, cancelled or
rebid. The University reserves the right to extend beyond
the Contract Term if deemed to be in the best interest of
the University. |
|
| Vendor(s) |
| 118309 |
| Apptec Laboratory Services |
| 2540 Exectutive Dr |
| Saint Paul MN 55120 |
| Sales Representative: |
PHONE # |
FAX # |
| Chuck Siegel |
651-675-2013 |
651-675-2005 |
| E-mail:Chuck.siegel@apptec-usa.com |
| |
PHONE # |
FAX # |
| Ordering/Expediting: |
651-675-2013 |
651-675-2005 |
| Invoice Information: |
651-675-2013 |
651-675-2005 |
| Returns: |
651-675-2013 |
651-675-2005 |
| Minority Reporting: |
651-675-2013 |
651-675-2005 |
| Website: www.apptec-usa.com |
|
| Commodity Code |
961-48 |
| Federal Employee ID # (FEIN) |
41-2006925 |
| F.O.B. |
“D” FOB DESTINATION, FREIGHT PREPAID AND ALLOWED |
| Terms: |
N/30 |
| Invoicing: |
Invoices shall reflect contract pricing |
| Orders: |
Fax, Internet (e-mail only) |
| Pricing Information: |
Contact purchasing agent at (608) 262-6557 for pricing. |
|
| Vendor(s) |
|
| Commodity Code |
961-48 |
| Federal Employee ID # (FEIN) |
54-1831899 |
| F.O.B. |
“D” FOB DESTINATION, FREIGHT PREPAID AND ALLOWED |
| Terms: |
N/30 |
| Invoicing: |
Invoices shall reflect contract pricing |
| Orders: |
Fax, Internet |
| Other: |
Pricing not available to: University of Wisconsin System campuses, State of Wisconsin Agencies or Wisconsin Municipalities |
| Pricing Information: |
Contact purchasing agent at (608) 262-6557 for pricing. |
|
| Vendor(s) |
| 130155 |
| Cogenics |
100 Perimeter Park Dr Ste C |
| Morrisville NC 27560 |
| Sales Representative: |
PHONE # |
FAX # |
| Michelle Cleggett |
734-604-5342 |
919-468-8766 |
| E-mail:mcleggett@cogenics.com |
| |
PHONE # |
FAX # |
| Ordering/Expediting: |
713-470-5428 |
877-792-5567 |
| Invoice Information: |
713-470-5428 |
877-792-5567 |
| Returns: |
713-470-5428 |
877-792-5567 |
| Minority Reporting: |
N/A |
|
| Website: www.cogenics.com |
|
| Commodity Code |
961-48 |
| Federal Employee ID # (FEIN) |
06-1338846 |
| F.O.B. |
“D” FOB DESTINATION, FREIGHT PREPAID AND ALLOWED |
| Terms: |
N/30 |
| Invoicing: |
Invoices shall reflect contract pricing |
| Orders: |
Fax, Internet |
| Other: |
Pricing not available to: State of Wisconsin Agencies or Wisconsin Municipalities |
| Pricing Information: |
Contact purchasing agent at (608) 262-6557 for pricing. |
|
There are typically 350 vials per lot tested. For our purposes, there is no difference between master and working cell banks. Any rodent testing would be a mouse.
Testing is required at varying intervals during the year. The sizes of the DNA will vary.
Microbial cell bank testing to include copy number determination by Southern Blot or equivalent method. |
| |
Test |
Human cell line |
Rodent Cell Line |
Microbial Cell Line |
| Bioburden (bacteria, fungi) |
PTC - 21 CFR 610.12 USP <71> |
PTC - 21 CFR 610.12 USP <71> |
Detect non-host organisms, USP <61> |
| Mycoplasma |
Please quote for PTC and EU Specifications |
Please quote for PTC and EU Specifications |
NA |
| Bovine adventitious virus |
Assay in susceptible bovine cell line, 9CFR113 for all RMs |
Assay in susceptible bovine cell line, 9CFR113 for all RMs |
NA |
| Porcine adventitious virus |
Assay in susceptible porcine cell line, 9CFR113 for all RMs |
Assay in susceptible porcine cell line, 9CFR113 for all RMs |
NA |
| Adventitious virus- In vitro assay |
3 cell types, inoculate with lysate - please quote for additional lines in case needed |
3 cell types, inoculate with lysate - please quote for additional lines in case needed |
NA |
| Adventitious virus - In vivo assay |
Suckling/adult mice, guinea pigs, in ovo |
Suckling/adult mice, guinea pigs, in ovo |
NA |
| Cell Line Characterization |
Isoenzyme Analysis Karyotyping – G-band STR ID Testing |
Isoenzyme Analysis STR ID Testing |
DNA Sequencing, Plasmid Copy Number, Integration/Retention, Restriction Map |
| Retrovirus |
SEM, cell culture amplification with S+L- infectivity assay, PERT - RT |
SEM, cell culture amplification with S+L- infectivity assay, PERT - RT |
NA |
| Retrovirus/Viruses |
Transmission EM |
Transmission EM |
NA |
| Tumorogenicity |
In-Vivo and In-Vitro assays per PTC |
NA for continuous rodent lines |
NA |
| Species-specific virus |
HIV-1/2, HTLV 1/2,HAV, HCV, HBV, CMV, EBV, HHV-6, HHV-7, HHV-8, Human Parvovirus B19, AAV, Human Polyoma Virus BKV & JCV, Enterovirus, VZV, SV40, HSV, Rubella, Coronavirus, Influenza Type C, Measels, Reovirus, Chlamydia, HPIV-1, 2 & 3, |
(MAP, RAP, or HAP) XC plaque -ecotropic murine leukemia virus |
Bacteriophage testing |
| Other |
|
|
Presence of Host Cell DNA |
|
|
|
Revision History
AMENDMENT #1 (9/21/07): issued to withdraw Lancaster Laboratories from this contract in its entirety.
|
