Strona główna
Logo unii europejskiej

Development and GMP production of microbicide gel formulation

Data publikacji: 24.04.2018

Informacje o ogłoszeniu

Termin składania ofert

do dnia 31-05-2018

Numer ogłoszenia

1106827

Status ogłoszenia

Zakończone

Treść ogłoszenia została zmieniona

Wydłużono termin na złożenie oferty do 31.05.2018 r.

Miejsce i sposób składania ofert

The tender should be sent by email to: beata.b@orionbiotechnology.com, by post, by courier or delivered personally to the address by May 24th, 2018 at 12:00PM: Orion Biotechnology Poland sp. z o.o. ul. Bobrzyńskiego 14, 30-348 Kraków, POLAND

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 Poland (formally K2 Biomedical) is seeking a CMO to develop their NOV-1004 (OB002H) protein as a gel formulation product for the treatment of HIV. Preclinical development work is currently underway to manufacture a gel formulation for GLP studies as bulk and to supply third party testing. Orion Poland requires a proposal to cover work associated with GMP clinical manufacturing of an active and placebo gel formulation to support a Phase 1 clinical trial.

Kategoria ogłoszenia

Usługi

Podkategoria ogłoszenia

Usługi badawcze

Miejsce realizacji zamówienia

Województwo: małopolskie Powiat: Kraków Miejscowość: Kraków

Opis przedmiotu zamówienia

Cel zamówienia

Orion Biotechnology Poland (formally K2 Biomedical) is seeking a CMO to develop their NOV-1004 (OB002H) protein as a gel formulation product for the treatment of HIV. Preclinical development work is currently underway to manufacture a gel formulation for GLP studies as bulk and to supply third party testing. Orion Poland requires a proposal to cover work associated with GMP clinical manufacturing of an active and placebo gel formulation to support a Phase 1 clinical trial.

Przedmiot zamówienia

DEVELOPMENT SCOPE • Tech transfer of gel manufacture method • Single development batch (active) to confirm GMP process and applicator filling • Stability of gel within the applicator, tested at 5-time points over 12 months at 25°C/60%RH and 40°C/75%RH • Tech transfer and validation of analytical methods: o RP-HPLC assay for purity and related substances o Strong cation exchange HPLC for concentration: o R5-tropic HIV envelope-dependent cell fusion assay for potency o Sorbic acid content via HPLC o Viscosity o pH o Osmolarity o Appearance and color o Bioburden • Transfer and qualification of the analytical methods suitable for Phase I clinical development

MANUFACTURING SCOPE • Preparation of a supplies and distribution protocol and batch manufacturing records • One gel production and applicator filling campaign o Suitable batch records and specifications to be written for the product o Release testing of the gel product as per test list above alongside microbial testing o Stability study for the bulk and packed gel product for a minimum of 6 months at 40C/75%RH and 12 months at 25C/60%RH • Production of a placebo to match (PTM) alongside suitable stability testing to support the duration of the clinical study (minimum of 6 months). This will be required for the MAD section of the clinical trial. • QP review and approval of all finished products • Applicators (HTI Plastics Prefill Applicator Q012 - https://www.htiplastic.com/) will be filled, packaged and labeled (in accordance with EudraLex Vol 4 Annex 13) • Product within applicator will be shipped to Phase 1 clinical site

PHASE 1 CLINICAL TRIAL • Final product release to the clinica to be conducted by the CMO; Single dose cohort – 6 subjects per delivery route (vaginal and rectal); active drug product at 8 mg/mL in single HTI applicator (4mL product per applicator) o Total of 18 applicators (6/dose/compartment + 3/dose/compartment for overage) • Multi-dose cohort – 18 subjects per delivery route (vaginal and rectal) randomized 2:1 active:placebo; active drug product at 8mg/mL with 5-daily dosing time points in single HTI applicator per time point (4mL product per applicator); Matched placebo gel at 5-daily dosing time points in single HTI applicator per time point (4mL placebo per applicator) o Active: Total of 144 applicators (60/dose/compartment + 12/dose/compartment for overage) o Placebo: Total of 72 applicators (30/dose/compartment + 6/dose/compartment for overage)

Kod CPV

73000000-2

Nazwa kodu CPV

Usługi badawcze i eksperymentalno-rozwojowe oraz pokrewne usługi doradcze

Dodatkowe przedmioty zamówienia

Not applicable

Harmonogram realizacji zamówienia

TIMELINES & BUDGET Contractor will assign a lead contact within contractor organization that will be Orion Poland’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 Poland sp. z o.o. project concerning Development of a new candidate microbicide for the prevention of HIV transmission

Deadline for completion of the subject of the order: up to 24 months or shorter from fulfilment of the below conditions by Purchaser:
1. Receipt of subsidy from structural funds of the European Union within Competition 1 / 1.1.1 / 2018 "Fast track" SMEs, Priority I: Support for conducting R & D works by enterprises, Submeasure 1.1.1. Industrial research and development works carried out by company.
Project co-financed by the European Regional Development Funds under the Measure 1.2 Operational Program in sectoral programme InnoNeuroPharm

2. NCBiR will not object against hiring Contractor.

Załączniki

Pytania i wyjaśnienia

Brak pytań i wyjaśnień

Uprawnienia do wykonywania określonej działalności lub czynności

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 GMP batch productions with any applicable certifications. 3. Documented, relevant company capabilities and infrastructure to fulfill project needs. 4. Program completion within Orion Biotechnology Poland’s required timeframe.

The entry criteria (1-4) must be met by the bidder. Only in this case will be evaluated based on price criterion.

Wiedza i doświadczenie

Yes

Potencjał techniczny

Yes

Osoby zdolne do wykonania zamówienia

Yes

Sytuacja ekonomiczna i finansowa

Not applicable

Dodatkowe warunki

Equity or personal relationship

Warunki zmiany umowy

Not applicable

Lista dokumentów/oświadczeń wymaganych od Wykonawcy

Contractor should prepare the tender offer in English or Polish.

The offer should have: • 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 GMP production 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

Not applicable

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 GMP batch productions with any applicable certifications. 3. Documented, relevant company capabilities and infrastructure to fulfill project needs. 4. Program completion within Orion Biotechnology Poland’s required timeframe.

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

Informacja o wybranym wykonawcy

Rozstrzygnięte

Nazwa i adres, data wpłynięcia oferty oraz jej cena

Nazwa i adres: QUOTIENT SCIENCES
Data wpłynięcia: 31.05.2018
Cena oferty: 168 517 GBP
Liczba wyświetleń: 171