Zapytanie ofertowe nr 24 04 2026 IM - Risk Evaluation and Control Strategy for Impurities in Support of IMPD Preparation
Notice description
Powstaje w kontekście projektu:
FENG.01.01-IP.01-1012/23 - Nowa terapia celowana nowotworów z delecją genu MTAP – II faza / New targeted therapy for tumors with a deletion of the MTAP gene – phase II
Risk Evaluation and Control Strategy for Impurities in Support of IMPD Preparation
Detailed impurities control evaluation services related to the proprietary clinical phase 1-suitable API manufacturing process:
1. Mutagenicity / Genotoxicity Assessment:
1.1. Conduct genotoxicity and mutagenicity assessment of all identified and potential organic impurities using Lhasa DEREK Nexus and Lhasa SARAH Nexus or equivalent (QSAR) expert rule – based and statistical prediction systems recognized by global regulatory agencies under ICH M7(R2).
1.2. Assess potential structural alerts, supporting conclusions with scientifically justified expert review following ICH M7 guidelines (including classification into Classes 1–5).
1.3. Utilize Lhasa’s Mirabilis or equivalent risk-based modeling tools for purge and likelihood analysis, consistent with ICH M7 recommendations on applying process knowledge and fate/purge principles (optional).
2. Impurity Identification and Process-Based Risk Analysis:
2.1. Propose a comprehensive list of process - and degradation-related organic impurities based on received structures and process understanding.
2.2. Evaluate each impurity for mutagenic potential and relevance, consistent with ICH Q3A/B impurity frameworks and ICH M7 requirements.
3. Carryover / Purge Assessment (optional):
Perform data-supported assessment of impurity carryover risk across the API manufacturing process using Lhasa Mirabilis software or other equivalent, regulator-accepted purge modeling tools. Apply ICH M7(R2) and ICH Q9 quality risk management principles demonstrating adequate control strategies, purge justification (e.g., Option 4), and risk-ranking of impurities.
4. Nitrosamine Risk Assessment:
4.1. Conduct a step-by-step nitrosamine formation risk assessment in alignment with the EMA’s "Guideline on the Limits of Genotoxic Impurities", EMA/FDA Nitrosamine Guidelines, ICH M7(R2), and supporting Q&A documents.
4.2. Evaluate potential nitrosamine precursors, nitrosating conditions, reagent/solvent compatibility, and formation pathways throughout the full synthetic route.
4.3. Provide risk classification and recommendations for mitigation and control strategies consistent with global regulatory expectations.
All evaluations must be conducted following the principles outlined in ICH M7(R2) for mutagenic impurities, ICH Q3A(R2), ICH Q3B(R2), ICH Q7, and ICH S9 (where applicable to oncology products), as well as relevant EMA/FDA nitrosamine guidance, including the FDA's "Risk Assessment of Nitrosamine Impurities in Human Drugs" and associated Q&A documents.
Selected bidder must provide the deliverables as results of the service. The cost of the deliverables given below must be included in the offer or calculated into the price of the services:
• Mutagenicity assessment report based on DEREK/SARAH or equivalent (ICH M7-compliant QSAR evaluation).
• Impurity list with carryover/purge justification, supported by Mirabilis or equivalent simulations and ICH M7 fate/purge principles (Optional).
• Nitrosamine risk assessment report aligned with EMA/FDA guidance and ICH M7.
Miejsce realizacji
Kraj: Polska, Województwo: małopolskie, Powiat: Kraków, Gmina: Kraków-Podgórze, Miejscowość: Kraków
FENG.01.01-IP.01-1012/23 - Nowa terapia celowana nowotworów z delecją genu MTAP – II faza / New targeted therapy for tumors with a deletion of the MTAP gene – phase II
Risk Evaluation and Control Strategy for Impurities in Support of IMPD Preparation
Detailed impurities control evaluation services related to the proprietary clinical phase 1-suitable API manufacturing process:
1. Mutagenicity / Genotoxicity Assessment:
1.1. Conduct genotoxicity and mutagenicity assessment of all identified and potential organic impurities using Lhasa DEREK Nexus and Lhasa SARAH Nexus or equivalent (QSAR) expert rule – based and statistical prediction systems recognized by global regulatory agencies under ICH M7(R2).
1.2. Assess potential structural alerts, supporting conclusions with scientifically justified expert review following ICH M7 guidelines (including classification into Classes 1–5).
1.3. Utilize Lhasa’s Mirabilis or equivalent risk-based modeling tools for purge and likelihood analysis, consistent with ICH M7 recommendations on applying process knowledge and fate/purge principles (optional).
2. Impurity Identification and Process-Based Risk Analysis:
2.1. Propose a comprehensive list of process - and degradation-related organic impurities based on received structures and process understanding.
2.2. Evaluate each impurity for mutagenic potential and relevance, consistent with ICH Q3A/B impurity frameworks and ICH M7 requirements.
3. Carryover / Purge Assessment (optional):
Perform data-supported assessment of impurity carryover risk across the API manufacturing process using Lhasa Mirabilis software or other equivalent, regulator-accepted purge modeling tools. Apply ICH M7(R2) and ICH Q9 quality risk management principles demonstrating adequate control strategies, purge justification (e.g., Option 4), and risk-ranking of impurities.
4. Nitrosamine Risk Assessment:
4.1. Conduct a step-by-step nitrosamine formation risk assessment in alignment with the EMA’s "Guideline on the Limits of Genotoxic Impurities", EMA/FDA Nitrosamine Guidelines, ICH M7(R2), and supporting Q&A documents.
4.2. Evaluate potential nitrosamine precursors, nitrosating conditions, reagent/solvent compatibility, and formation pathways throughout the full synthetic route.
4.3. Provide risk classification and recommendations for mitigation and control strategies consistent with global regulatory expectations.
All evaluations must be conducted following the principles outlined in ICH M7(R2) for mutagenic impurities, ICH Q3A(R2), ICH Q3B(R2), ICH Q7, and ICH S9 (where applicable to oncology products), as well as relevant EMA/FDA nitrosamine guidance, including the FDA's "Risk Assessment of Nitrosamine Impurities in Human Drugs" and associated Q&A documents.
Selected bidder must provide the deliverables as results of the service. The cost of the deliverables given below must be included in the offer or calculated into the price of the services:
• Mutagenicity assessment report based on DEREK/SARAH or equivalent (ICH M7-compliant QSAR evaluation).
• Impurity list with carryover/purge justification, supported by Mirabilis or equivalent simulations and ICH M7 fate/purge principles (Optional).
• Nitrosamine risk assessment report aligned with EMA/FDA guidance and ICH M7.
Miejsce realizacji
Kraj: Polska, Województwo: małopolskie, Powiat: Kraków, Gmina: Kraków-Podgórze, Miejscowość: Kraków
Time limit for receipt of tenders
2026-05-04 21:59:59.0
Location
Kraj: Polska, Województwo: małopolskie, Powiat: Kraków, Gmina: Kraków-Podgórze, Miejscowość: Kraków
Category assortment
Measurements, tests and technical acceptance
Buyer details
RYVU THERAPEUTICS S.A.
Sternbacha 2
30-394 Kraków
Województwo: małopolskie
Kraj: Polska
NIP: 6792942955
Sternbacha 2
30-394 Kraków
Województwo: małopolskie
Kraj: Polska
NIP: 6792942955
