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The development and GLP validation of clinical pharmacokinetic bioanalytics

Data publikacji: 19.09.2018

Informacje o ogłoszeniu

Termin składania ofert

do dnia 26-09-2018

Numer ogłoszenia

1138169

Status ogłoszenia

Zakończone

Treść ogłoszenia została zmieniona

Swab analysis has been removed from the scope of work.

Miejsce i sposób składania ofert

1. The tender should be sent by email to: beata.b@orionbiotechnology.com, by post, by courier or delivered personally to the address by September 26th, 2018 at 12:00PM:
Orion Biotechnology Poland sp. z o.o. ul. Bobrzynskiego 14, 30-348 Kraków, POLAND
2. Tender evaluation shall be made on September 28th, 2018 and the results and choice of the most favorable tender will be announced on at http://www.bazakonkurencyjnosci.funduszeeuropejskie.gov.pl
3. Tenders submitted after deadline shall not be examined.
4. Contractor may amend or withdraw the tender offer before the deadline.
5. In the course of examination and tenders evaluation Purchaser may request from Contractors explanations concerning the content of submitted tenders.
6. Enquiry for quotation has been placed on following websites: http://www.bazakonkurencyjnosci.funduszeeuropejskie.gov.pl

Adres e-mail, na który należy wysłać ofertę

beata.b@orionbiotechnology.com

Osoba do kontaktu w sprawie ogłoszenia

Jarret Engstrom

Skrócony opis przedmiotu zamówienia

Orion Biotechnology Polska is seeking a CRO to develop and validate an ELISA-based assay to measure pharmacokinetic levels of the company’s microbicide drug candidate, OB-002H, for the prevention of HIV.
Orion Polska has previously developed, setup and validated assays for the detection of our drug candidate in samples derived from the company’s preclinical toxicology programs. The scope of this work will be to transition from animal matrices to the use of human samples. The assay will involve the use of a recombinant anti-OB-002H capture antibody, which will be supplied by Orion Polska, together with a commercially available anti-human detection antibody.
The company requests a proposal to cover work associated with the setup and validation of this ELISA-based assay, to GLP regulatory standards appropriate for Phase 1. Per a clinical protocol synopsis, the first-in-human clinically derived samples will include serum, all sample matrices will need methods development and assay validation.

TIMELINES & BUDGET
Contractor will assign a lead contact within contractor organization that will be Orion Polska’s main technical contact for communication and to ensure adherence to mutually agreeable timelines and budgets.
1. Detailed description of the subject of the order:
Procurement of the services for the company Orion Biotechnology Polska sp. z o.o. project concerning
Development of a new candidate microbicide for the prevention of HIV transmission

Reference:
(Common Procurement Vocabulary - CPV 73100000-3, Research and experimental development services)

Kategoria ogłoszenia

Usługi

Podkategoria ogłoszenia

Usługi badawcze

Miejsce realizacji zamówienia

Województwo: małopolskie Powiat: Kraków Miejscowość: Kraków

Opis przedmiotu zamówienia

Cel zamówienia

1. Detailed description of the subject of the order:
Procurement of the services for the company Orion Biotechnology Polska sp. z o.o. project concerning
Development of a new candidate microbicide for the prevention of HIV transmission

Reference:
(Common Procurement Vocabulary - CPV 73100000-3, Research and experimental development services)

Przedmiot zamówienia

Orion Biotechnology Polska is seeking a CRO to develop and validate an ELISA-based assay to measure pharmacokinetic levels of the company’s microbicide drug candidate, OB-002H, for the prevention of HIV.
Orion Polska has previously developed, setup and validated assays for the detection of our drug candidate in samples derived from the company’s preclinical toxicology programs. The scope of this work will be to transition from animal matrices to the use of human samples. The assay will involve the use of a recombinant anti-OB-002H capture antibody, which will be supplied by Orion Polska, together with a commercially available anti-human detection antibody.
The company requests a proposal to cover work associated with the setup and validation of this ELISA-based assay, to GLP regulatory standards appropriate for Phase 1. Per a clinical protocol synopsis, the first-in-human clinically derived samples will include serum, all sample matrices will need methods development and assay validation.

TIMELINES & BUDGET
Contractor will assign a lead contact within contractor organization that will be Orion Polska’s main technical contact for communication and to ensure adherence to mutually agreeable timelines and budgets.
1. Detailed description of the subject of the order:
Procurement of the services for the company Orion Biotechnology Polska sp. z o.o. project concerning
Development of a new candidate microbicide for the prevention of HIV transmission

Reference:
(Common Procurement Vocabulary - CPV 73100000-3, Research and experimental development services)

Kod CPV

73100000-3

Nazwa kodu CPV

Usługi badawcze i eksperymentalno-rozwojowe

Dodatkowe przedmioty zamówienia

XI. SUPPLEMENTARY ORDERS
The Ordering Party reserves the option of awarding a supplementary order to the selected contractor in the result of the procedure, in a quantity not exceeding 50% of the quantity specified in this request for proposal. The subject of supplementary order will be consistent with the subject of the basic contract.

Harmonogram realizacji zamówienia

Deadline for completion of the subject of the order: up to 9 months or shorter from fulfilment of the below conditions by Purchaser:
1. Receipt of subsidy from structural funds of the European Union within Sectoral Programme InnoNeuroPharm, Priority Axis I: Supporting R&D carried out by enterprises, Measure 1.2: Sectoral R&D Programmes of Intelligent Development Operational Programme for the period 2014-2020 for the project by Purchaser.
2. NCBiR will not object against hiring Contractor.

Załączniki

Pytania i wyjaśnienia

Uprawnienia do wykonywania określonej działalności lub czynności

Contractor must prepare the tender offer in English or Polish on the attached offer form (Attachment No 2). The offer must:
• Include the full name of a Contractor and contact details;
• Include date of the offer/submission date (In the absence of the date of issue on the tenders submitted by e-mail, date of receipt will be equivalent to the issue of the offer).
• Include price for order (without VAT/TAX). The Ordering Party accepts the tenders with prices given in different currency, however, for the purposes of comparison the tender price will be converted into PLN using current exchange rates at the time of tender (Average Exchange Rate Table of the National Bank of Poland (NBP): http://www.nbp.pl/). To avoid any doubts, the tender prices in PLN will be used only for comparing the tenders and for awarding scores; all settlements with the Contractor will be in the currency of the offer.
• Include Vendor’s certification’s and portfolio of highlighted experience in the field of clinical bioanalytic programs set out in clause VII;
• Describe all additional elements required for tender;
• Estimated date of completion of the contract;
• RFQ expiration date specified – at least 90 calendar days from the RFQ end date to enable
Service Agreement finalization;
• Be legibly signed by the Contractor.

A lack of any of the above mentioned items may result in rejection of the tender for formal reasons.

Wiedza i doświadczenie

YES

Potencjał techniczny

YES

Osoby zdolne do wykonania zamówienia

Not applicable

Sytuacja ekonomiczna i finansowa

Not applicable

Dodatkowe warunki

Not applicable

Warunki zmiany umowy

Only by annex

Lista dokumentów/oświadczeń wymaganych od Wykonawcy

Contractor must prepare the tender offer in English or Polish on the attached offer form (Attachment No 2). The offer must:
• Include the full name of a Contractor and contact details;
• Include date of the offer/submission date (In the absence of the date of issue on the tenders submitted by e-mail, date of receipt will be equivalent to the issue of the offer).
• Include price for order (without VAT/TAX). The Ordering Party accepts the tenders with prices given in different currency, however, for the purposes of comparison the tender price will be converted into PLN using current exchange rates at the time of tender (Average Exchange Rate Table of the National Bank of Poland (NBP): http://www.nbp.pl/). To avoid any doubts, the tender prices in PLN will be used only for comparing the tenders and for awarding scores; all settlements with the Contractor will be in the currency of the offer.
• Include Vendor’s certification’s and portfolio of highlighted experience in the field of clinical bioanalytic programs set out in clause VII;
• Describe all additional elements required for tender;
• Estimated date of completion of the contract;
• RFQ expiration date specified – at least 90 calendar days from the RFQ end date to enable
Service Agreement finalization;
• Be legibly signed by the Contractor.

A lack of any of the above mentioned items may result in rejection of the tender for formal reasons.

Zamówienia uzupełniające

The Ordering Party reserves the option of awarding a supplementary order to the selected contractor in the result of the procedure, in a quantity not exceeding 50% of the quantity specified in this request for proposal. The subject of supplementary order will be consistent with the subject of the basic contract.

Ocena oferty

Kryteria oceny i opis sposobu przyznawania punktacji

Purchaser shall evaluate valid tenders on the basis of the following criteria:
Entry criteria/basic requirements (YES/NO):
1. Accuracy to requested subject of order (Section II).
2. Documented, relevant company experience and successful track record in conducting similar GLP assay validations, with any applicable certifications (at least 2).
3. Documented, relevant company capabilities and infrastructure to fulfill project needs.
4. Program completion within Orion Biotechnology Poland’s required timeframe (up to 9 months).

The entry criteria (1-4) must be met by the bidder. Only in this case will be evaluated based on price criterion.
Method of assessment:
The ordering party will select the offer with the lowest price among the offers complying with the requirements of the proceedings.

Wykluczenia

Equity or personal relationship

Zamawiający - Beneficjent

Nazwa

K2 BIOMEDICAL SP. Z O.O.

Adres

prof. Michała Bobrzyńskiego 14

30-348 Kraków

małopolskie , Kraków

Numer telefonu

694413749

NIP

6762495612

Tytuł projektu

Opracowanie nowego kandydata na lek mikrobójczy zapobiegający przenoszeniu wirusa HIV

Numer projektu

POIR.01.02.00-00-0003/17-00

Inne źródła finansowania

Not applicable
Liczba wyświetleń: 78