Service for scaling up a chemical substance

Invitation to tender

Karolinska Institutet, hereinafter called KI, invites companies, hereinafter called Tenderers, to submit tenders concerning pharmaceutical development through scale-up and manufacture of a chemical substance, a small molecule anti-cancer compound, according to GMP requirements.

Background to the procurement

Prof Thomas Helleday, The Department of Oncology and Pathology, has recently discovered a highly potent small inhibitor of MTHFD2 which shows promise in several cancer models in cells and rodents. The next step is to take this inhibitor through GLP toxicology studies and IND filing before entering first-time-in man studies.

To do this The Helleday Lab wish to procure the active pharmaceutical ingredient (API) from a contract manufacturing organization, that has certified regulatory experience in the GMP synthesis of highly potent compounds.

Agreement term

KI has intention to sign a contract with one (1) supplier.

The agreement period is (4) years.

Invitation to tender

Karolinska Institutet, hereinafter called KI, invites companies, hereinafter called Tenderers, to submit tenders concerning pharmaceutical development through scale-up and manufacture of a chemical substance, a small molecule anti-cancer compound, according to GMP requirements.

The contract will be used by the Department of Oncology and Pathology, Karolinska Institutet (KI), Solna.

Karolinska Institutet, KI

Karolinska Institutet ("KI") is one of the world’s foremost medical universities. Our vision is to advance knowledge about life and strive towards better health for all.

As a university, KI is Sweden’s single largest centre of medical academic research and offers the country’s widest range of medical courses and programmes.

Since 1901 the Nobel Assembly at Karolinska Institutet has selected the Nobel laureates in Physiology or Medicine.

For additional information, please visit www.ki.se.

Background to the procurement

Prof Thomas Helleday, The Department of Oncology and Pathology, has recently discovered a highly potent small inhibitor of MTHFD2 which shows promise in several cancer models in cells and rodents. The next step is to take this inhibitor through GLP toxicology studies and IND filing before entering first-time-in man studies.

To do this The Helleday Lab wish to procure the active pharmaceutical ingredient (API) from a contract manufacturing organization, that has certified regulatory experience in the GMP synthesis of highly potent compounds.

Agreement term

KI has intention to sign a contract with one (1) supplier.

The agreement shall become effective when the parties, KI and the chosen supplier, have signed the contract. The exact start date shall be determined upon signing of the agreement.

The agreement period is (4) years.

Contents

The tender request documentation consists of the following document parts:1. Invitation to tender2. Administrative rules3. Evaluation and qualification4. Supplier qualification5. Technical requirements6. Commercial terms and conditionsAdditional information published during the procurement procedure is considered to be part of the procurement documents.The Tenderer is responsible for acquiring all of the procurement documents.

Procurement authority

Karolinska InstitutetReg. no: 202100-2973Visiting address:Nobels väg 5SE-171 77 Stockholm

Contact person during the procurement process

Any questions are to be asked via TendSign.

Contact person from purchasing and Procurement unit: Hanna Glad E-mail: hanna.glad@ki.se

Contact person from the department: Martin ScobieE-mail: martin.scobie@ki.se

Procurement procedure

The procurement is carried out as an Open procedure according to the Swedish Public Procurement Act (2016:1145) (LOU).

For more information concerning procurement procedures, please refer to http://www.upphandlingsmyndigheten.se/en/publicprocurement/.

Tender’s period of validity

The tender must be valid until 2022-03-04.

If necessary, KI may request an extension of the tender validity period, for example, if the procurement process or the contract award decision is appealed in court.

Compensation

KI shall reject all Tenderer’s claims for compensation for the work performed during participation in the procurement process.

Motivation for cancelling

When examining and evaluating tenders, it emerged that all tenders contain errors or/and are irrelevant to the contract with regard to the budget for the procurement. The dificiency cannot be cured by clarifications from the tenderer.

When no suitable tenders remain, the procurement is cancelled.

Mercell notice: https://opic.com/id/afkywbzkjj