Framework for QC Analytical Testing Requirements

A Contract Award Notice
by CENTRE FOR PROCESS INNOVATION LIMITED

Source
Find a Tender
Type
Contract (Services)
Duration
not specified
Value
£1M
Sector
INDUSTRIAL
Published
22 May 2025
Delivery
not specified
Deadline
n/a

Concepts

Location

Geochart for 1 buyers and 18 suppliers

1 buyer

6 suppliers

Description

You are invited to submit a tender for the following requirements; analytical services for multiple modalities drug substances and drug products required for early phase clinical trials. This tender is to cover the analytical services required for release analysis of drug substance (DS) and drug product (DP).

Lot Division

1 Water Testing (Glasgow Area)

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.)

Award Criteria
GMP Questionnaire 5
Technical Specification 20
Turnaround timescales (Lead Time) 20
Qualification and Experience 20
Order Processing, Account Management & Customer Service 5
price 30
2 RNA Therapeutic/Vaccines

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

Award Criteria
GMP Questionnaire 5
Technical Specification 20
Turnaround timescales (Lead Time) 20
- Qualification and Experience 20
Order Processing, Account Management & Customer Service 5
price 30
3 Recombinant Protein Therapeutics

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

Award Criteria
GMP Questionnaire 5
Technical Specification 20
Turnaround timescales (Lead Time) 20
Qualification and Experience 20
Order Processing, Account Management & Customer Service 5
price 30
4 Process and Product Microbiology (Teesside Area)

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)

Award Criteria
GMP Questionnaire 5
Technical Specification 20
Turnaround timescales (Lead Time) 20
Qualification and Experience 20
Order Processing, Account Management & Customer Service 5
price 30
5 Process and Product Microbiology (Glasgow Area)

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)

Award Criteria
GMP Questionnaire 5
Technical Specification 20
Turnaround timescales (Lead Time) 20
Qualification and Experience 20
Order Processing, Account Management & Customer Service 5
price 30
6 Oligonucleotides

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)

Award Criteria
GMP Questionnaire 5
Technical Specification 20
Turnaround timescales (Lead Time) 20
Qualification and Experience 20
Order Processing, Account Management & Customer Service 5
price 30

Award Detail

1 Assured Micro (Glasgow)
  • Water Testing (Glasgow Area)
  • Reference: 024445-2025-1
  • Value: £1,000,000 [share]
  • Awarded to group of suppliers.
2 Wickham Micro (Gosport)
  • Water Testing (Glasgow Area)
  • Reference: 024445-2025-1
  • Value: £1,000,000 [share]
  • Awarded to group of suppliers.
3 Reading Scientific Serices (Reading)
  • Water Testing (Glasgow Area)
  • Reference: 024445-2025-1
  • Value: £1,000,000 [share]
  • Awarded to group of suppliers.
4 Its Testing Services (Manchester)
  • RNA Therapeutic/Vaccines
  • Reference: 024445-2025-2
  • Value: £1,000,000 [share]
  • Awarded to group of suppliers.
5 Reading Scientific Serices (Reading)
  • RNA Therapeutic/Vaccines
  • Reference: 024445-2025-2
  • Value: £1,000,000 [share]
  • Awarded to group of suppliers.
6 SGS (Ellesmere Port)
  • RNA Therapeutic/Vaccines
  • Reference: 024445-2025-2
  • Value: £1,000,000 [share]
  • Awarded to group of suppliers.
7 SGS (Ellesmere Port)
  • Recombinant Protein Therapeutics
  • Reference: 024445-2025-3
  • Value: £1,000,000 [share]
  • Awarded to group of suppliers.
8 Its Testing Services (Manchester)
  • Recombinant Protein Therapeutics
  • Reference: 024445-2025-3
  • Value: £1,000,000 [share]
  • Awarded to group of suppliers.
9 Reading Scientific Serices (Reading)
  • Recombinant Protein Therapeutics
  • Reference: 024445-2025-3
  • Value: £1,000,000 [share]
  • Awarded to group of suppliers.
10 Reading Scientific Serices (Reading)
  • Process and Product Microbiology (Teesside Area)
  • Reference: 024445-2025-4
  • Value: £1,000,000 [share]
  • Awarded to group of suppliers.
11 Wickham Micro (Gosport)
  • Process and Product Microbiology (Teesside Area)
  • Reference: 024445-2025-4
  • Value: £1,000,000 [share]
  • Awarded to group of suppliers.
12 SGS (Ellesmere Port)
  • Process and Product Microbiology (Teesside Area)
  • Reference: 024445-2025-4
  • Value: £1,000,000 [share]
  • Awarded to group of suppliers.
13 Reading Scientific Serices (Reading)
  • Process and Product Microbiology (Glasgow Area)
  • Reference: 024445-2025-5
  • Value: £1,000,000 [share]
  • Awarded to group of suppliers.
14 Wickham Micro (Gosport)
  • Process and Product Microbiology (Glasgow Area)
  • Reference: 024445-2025-5
  • Value: £1,000,000 [share]
  • Awarded to group of suppliers.
15 Assured Micro (Glasgow)
  • Process and Product Microbiology (Glasgow Area)
  • Reference: 024445-2025-5
  • Value: £1,000,000 [share]
  • Awarded to group of suppliers.
16 Reading Scientific Serices (Reading)
  • Oligonucleotides
  • Reference: 024445-2025-6
  • Value: £1,000,000 [share]
  • Awarded to group of suppliers.
17 Its Testing Services (Manchester)
  • Oligonucleotides
  • Reference: 024445-2025-6
  • Value: £1,000,000 [share]
  • Awarded to group of suppliers.
18 Catsci (Cardiff)
  • Oligonucleotides
  • Reference: 024445-2025-6
  • Value: £1,000,000 [share]
  • Awarded to group of suppliers.

CPV Codes

  • 71620000 - Analysis services

Indicators

Other Information

** PREVIEW NOTICE, please check Find a Tender for full details. ** (SC Ref:797494)

Reference

Domains