Mae'r dogfennau caffael ar gael ar gyfer mynediad uniongyrchol anghyfyngedig a llawn, yn rhad ac am ddim ar:
Rhif y Lot 1
II.2.1) Teitl
Water Testing (Glasgow Area)
II.2.2) Cod(au) CPV ychwanegol
71620000
II.2.3) Man cyflawni
Cod NUTS:
UKM83
II.2.4) Disgrifiad o’r caffaeliad
The MMIC facility near Glasgow will require microbiological testing of water samples in accordance with Ph. Eur. [0169]. The following analysis techniques are required and have been included in pricing schedule for comparison:
-Microbiological monitoring (Ph. Eur.)
-Bacterial endotoxin testing (Ph. Eur.)
II.2.5) Meini prawf dyfarnu
Maen prawf isod:
Maes prawf ansawdd: GMP Questionnaire
/ Pwysoliad: 5
Maes prawf ansawdd: Technical Specification
/ Pwysoliad: 20
Maes prawf ansawdd: Turnaround timescales (Lead Time)
/ Pwysoliad: 20
Maes prawf ansawdd: Qualification and Experience
/ Pwysoliad: 20
Maes prawf ansawdd: Order Processing, Account Management & Customer Service
/ Pwysoliad: 5
Price
/ Pwysoliad:
30
II.2.7) Hyd y contract, y cytundeb fframwaith neu’r system brynu ddynamig
Hyd mewn misoedd: 48
Gall y contract hwn gael ei adnewyddu: Ydy
Disgrifiad o’r adnewyddiadau:
48 months with 1 additional 12 months period extension options
at the discretion of the Authority.
II.2.9) Gwybodaeth am y cyfyngiadau ar nifer yr ymgeiswyr a gaiff eu gwahodd
II.2.10) Gwybodaeth am amrywiadau
Derbynnir amrywiadau:
Ydy
II.2.11) Gwybodaeth am opsiynau
Opsiynau:
Na
II.2.13) Gwybodaeth am Gronfeydd yr Undeb Ewropeaidd
Mae'r broses gaffael yn gysylltiedig â phrosiect a/neu raglen a ariennir gan gronfeydd yr Undeb Ewropeaidd:
Na
Rhif y Lot 2
II.2.1) Teitl
RNA Therapeutic/Vaccines
II.2.2) Cod(au) CPV ychwanegol
71620000
II.2.3) Man cyflawni
Cod NUTS:
UKM83
II.2.4) Disgrifiad o’r caffaeliad
Our facility in Darlington currently manufactures RNA-LNP vaccines and therapeutics for Phase 1 clinical trials. Both the drug substance and drug product are presented as liquid formulations.
The requirements for RNA-LNP analysis include:
- Method development, verification and Phase appropriate validation (as required)
- Integrity analysis for RNA In-process samples, RNA-LNP drug substance and drug product (release and stability analysis)
- Process impurity testing for RNA-LNP drug substance and drug product
II.2.5) Meini prawf dyfarnu
Maen prawf isod:
Maes prawf ansawdd: GMP Questionnaire
/ Pwysoliad: 5
Maes prawf ansawdd: Technical Specification
/ Pwysoliad: 20
Maes prawf ansawdd: Turnaround timescales (Lead Time)
/ Pwysoliad: 20
Maes prawf ansawdd: - Qualification and Experience
/ Pwysoliad: 20
Maes prawf ansawdd: Order Processing, Account Management & Customer Service
/ Pwysoliad: 5
Price
/ Pwysoliad:
30
II.2.7) Hyd y contract, y cytundeb fframwaith neu’r system brynu ddynamig
Hyd mewn misoedd: 48
Gall y contract hwn gael ei adnewyddu: Ydy
Disgrifiad o’r adnewyddiadau:
48 months with 1 additional 12 months period extension options
at the discretion of the Authority.
II.2.9) Gwybodaeth am y cyfyngiadau ar nifer yr ymgeiswyr a gaiff eu gwahodd
II.2.10) Gwybodaeth am amrywiadau
Derbynnir amrywiadau:
Ydy
II.2.11) Gwybodaeth am opsiynau
Opsiynau:
Na
II.2.13) Gwybodaeth am Gronfeydd yr Undeb Ewropeaidd
Mae'r broses gaffael yn gysylltiedig â phrosiect a/neu raglen a ariennir gan gronfeydd yr Undeb Ewropeaidd:
Na
Rhif y Lot 3
II.2.1) Teitl
Recombinant Protein Therapeutics
II.2.2) Cod(au) CPV ychwanegol
71620000
II.2.3) Man cyflawni
Cod NUTS:
UKM83
II.2.4) Disgrifiad o’r caffaeliad
Our facility in Darlington will, in the future, manufacture Recombinant protein vaccines and therapeutics produced in Microbial cell lines, for Phase 1 clinical trials. Both the drug substance and drug product are presented as liquid formulations.
The requirements for Recombinant Protein analysis include:
- Method development, verification and Phase appropriate validation (as required)
- Integrity analysis for Recombinant Protein drug substance and drug product (release and stability analysis)
- Process impurity testing for Recombinant Protein drug substance and drug product
II.2.5) Meini prawf dyfarnu
Maen prawf isod:
Maes prawf ansawdd: GMP Questionnaire
/ Pwysoliad: 5
Maes prawf ansawdd: Technical Specification
/ Pwysoliad: 20
Maes prawf ansawdd: Turnaround timescales (Lead Time)
/ Pwysoliad: 20
Maes prawf ansawdd: Qualification and Experience
/ Pwysoliad: 20
Maes prawf ansawdd: Order Processing, Account Management & Customer Service
/ Pwysoliad: 5
Price
/ Pwysoliad:
30
II.2.7) Hyd y contract, y cytundeb fframwaith neu’r system brynu ddynamig
Hyd mewn misoedd: 48
Gall y contract hwn gael ei adnewyddu: Ydy
Disgrifiad o’r adnewyddiadau:
48 months with 1 additional 12 months period extension options
at the discretion of the Authority.
II.2.9) Gwybodaeth am y cyfyngiadau ar nifer yr ymgeiswyr a gaiff eu gwahodd
II.2.10) Gwybodaeth am amrywiadau
Derbynnir amrywiadau:
Ydy
II.2.11) Gwybodaeth am opsiynau
Opsiynau:
Na
II.2.13) Gwybodaeth am Gronfeydd yr Undeb Ewropeaidd
Mae'r broses gaffael yn gysylltiedig â phrosiect a/neu raglen a ariennir gan gronfeydd yr Undeb Ewropeaidd:
Na
Rhif y Lot 4
II.2.1) Teitl
Process and Product Microbiology (Teesside Area)
II.2.2) Cod(au) CPV ychwanegol
71620000
II.2.3) Man cyflawni
Cod NUTS:
UKM83
II.2.4) Disgrifiad o’r caffaeliad
Our facility in Darlington will require Microbiology testing to support the RNA-LNP and Recombinant Protein GMP manufacture.
The following analysis is required, all under Ph.Eur:
- Endotoxin (Buffers)
- Endotoxin (Process product Protein)
- Endotoxin (Process product RNA and RNA-LNP)
- Bioburden (Buffers)
- Bioburden (Process product Protein)
- Bioburden (Process product RNA and RNA-LNP)
II.2.5) Meini prawf dyfarnu
Maen prawf isod:
Maes prawf ansawdd: GMP Questionnaire
/ Pwysoliad: 5
Maes prawf ansawdd: Technical Specification
/ Pwysoliad: 20
Maes prawf ansawdd: Turnaround timescales (Lead Time)
/ Pwysoliad: 20
Maes prawf ansawdd: Qualification and Experience
/ Pwysoliad: 20
Maes prawf ansawdd: Order Processing, Account Management & Customer Service
/ Pwysoliad: 5
Price
/ Pwysoliad:
30
II.2.7) Hyd y contract, y cytundeb fframwaith neu’r system brynu ddynamig
Hyd mewn misoedd: 48
Gall y contract hwn gael ei adnewyddu: Ydy
Disgrifiad o’r adnewyddiadau:
48 months with 1 additional 12 months period extension options
at the discretion of the Authority.
II.2.9) Gwybodaeth am y cyfyngiadau ar nifer yr ymgeiswyr a gaiff eu gwahodd
II.2.10) Gwybodaeth am amrywiadau
Derbynnir amrywiadau:
Ydy
II.2.11) Gwybodaeth am opsiynau
Opsiynau:
Na
II.2.13) Gwybodaeth am Gronfeydd yr Undeb Ewropeaidd
Mae'r broses gaffael yn gysylltiedig â phrosiect a/neu raglen a ariennir gan gronfeydd yr Undeb Ewropeaidd:
Na
Rhif y Lot 5
II.2.1) Teitl
Process and Product Microbiology (Glasgow Area)
II.2.2) Cod(au) CPV ychwanegol
71620000
II.2.3) Man cyflawni
Cod NUTS:
UKM83
II.2.4) Disgrifiad o’r caffaeliad
Our facility in Glasgow will require Microbiology testing to support the GMP manufacturing of oligonucleotide therapies.
The following analysis is required, all under Ph.Eur:
- Endotoxin (Process product oligonucleotide)
- Bioburden (Process product oligonucleotide)
II.2.5) Meini prawf dyfarnu
Maen prawf isod:
Maes prawf ansawdd: GMP Questionnaire
/ Pwysoliad: 5
Maes prawf ansawdd: Technical Specification
/ Pwysoliad: 20
Maes prawf ansawdd: Turnaround timescales (Lead Time)
/ Pwysoliad: 20
Maes prawf ansawdd: Qualification and Experience
/ Pwysoliad: 20
Maes prawf ansawdd: Order Processing, Account Management & Customer Service
/ Pwysoliad: 5
Price
/ Pwysoliad:
30
II.2.7) Hyd y contract, y cytundeb fframwaith neu’r system brynu ddynamig
Hyd mewn misoedd: 48
Gall y contract hwn gael ei adnewyddu: Ydy
Disgrifiad o’r adnewyddiadau:
48 months with 1 additional 12 months period extension options
at the discretion of the Authority.
II.2.9) Gwybodaeth am y cyfyngiadau ar nifer yr ymgeiswyr a gaiff eu gwahodd
II.2.10) Gwybodaeth am amrywiadau
Derbynnir amrywiadau:
Ydy
II.2.11) Gwybodaeth am opsiynau
Opsiynau:
Na
II.2.13) Gwybodaeth am Gronfeydd yr Undeb Ewropeaidd
Mae'r broses gaffael yn gysylltiedig â phrosiect a/neu raglen a ariennir gan gronfeydd yr Undeb Ewropeaidd:
Na
Rhif y Lot 6
II.2.1) Teitl
Oligonucleotides
II.2.2) Cod(au) CPV ychwanegol
71620000
II.2.3) Man cyflawni
Cod NUTS:
UKM83
II.2.4) Disgrifiad o’r caffaeliad
The facility at MMIC will manufacture both single and double stranded novel oligonucleotides for early phase clinical trials. The drug substance (API) may be a lyophilised powder or solution API and the finished drug product may be a solid or liquid formulation.
The requirements for oligonucleotides analysis include:
- Chemical analysis for oligonucleotide drug substance and drug product (release and stability analysis)
- Method development, verification and phase appropriate validation (as required)
II.2.5) Meini prawf dyfarnu
Maen prawf isod:
Maes prawf ansawdd: GMP Questionnaire
/ Pwysoliad: 5
Maes prawf ansawdd: Technical Specification
/ Pwysoliad: 20
Maes prawf ansawdd: Turnaround timescales (Lead Time)
/ Pwysoliad: 20
Maes prawf ansawdd: Qualification and Experience
/ Pwysoliad: 20
Maes prawf ansawdd: Order Processing, Account Management & Customer Service
/ Pwysoliad: 5
Price
/ Pwysoliad:
30
II.2.7) Hyd y contract, y cytundeb fframwaith neu’r system brynu ddynamig
Hyd mewn misoedd: 48
Gall y contract hwn gael ei adnewyddu: Ydy
Disgrifiad o’r adnewyddiadau:
48 months with 1 additional 12 months period extension options
at the discretion of the Authority.
II.2.9) Gwybodaeth am y cyfyngiadau ar nifer yr ymgeiswyr a gaiff eu gwahodd
II.2.10) Gwybodaeth am amrywiadau
Derbynnir amrywiadau:
Ydy
II.2.11) Gwybodaeth am opsiynau
Opsiynau:
Na
II.2.13) Gwybodaeth am Gronfeydd yr Undeb Ewropeaidd
Mae'r broses gaffael yn gysylltiedig â phrosiect a/neu raglen a ariennir gan gronfeydd yr Undeb Ewropeaidd:
Na
NOTE: To register your interest in this notice and obtain any additional information please visit the Public Contracts Scotland Web Site at https://www.publiccontractsscotland.gov.uk/Search/Search_Switch.aspx?ID=774949.
A sub-contract clause has been included in this contract. For more information see: http://www.publiccontractsscotland.gov.uk/info/InfoCentre.aspx?ID=2363
Community benefits are included in this requirement. For more information see: https://www.gov.scot/policies/public-sector-procurement/community-benefits-in-procurement/