{"status":"OK","data":{"advertisement":{"id":390693,"title":"Kopia Przygotowanie i przekazanie rekombinowanego lentiwirusa trzeciej generacji w standardzie jako\u015bci EU GMP, przeprowadzenie bada\u0144 stabilno\u015bci, wytworzenie zgodnie z EU GMP oraz przekazanie w trzech odr\u0119bnych transzach o mianie funkcjonalnym \u226510\u2077 TU/ml\n\nPreparation and delivery, in three separate batches, of a third-generation recombinant lentivirus manufactured in accordance with EU GMP requirements and having a functional titre of \u226510\u2077 TU/ml, together with the performance of stability studies.","partial_offer_allowed":false,"publication_date":"2026-10-13","submission_deadline":"2026-10-21 23:59:59","planned_sign_date":"2026-11-01","supplementary_orders":"Zamawiaj\u0105cy zastrzega sobie prawo do udzielenia Wykonawcy zam\u00f3wie\u0144 dodatkowych, nieobj\u0119tych zam\u00f3wieniem podstawowym, kt\u00f3rych celem jest cz\u0119\u015bciowa wymiana lub uzupe\u0142nienie materia\u0142\u00f3w obj\u0119tych zam\u00f3wieniem albo zwi\u0119kszenie zakresu bie\u017c\u0105cych \u015bwiadcze\u0144, o warto\u015bci nieprzekraczaj\u0105cej 50% warto\u015bci przedmiotu zam\u00f3wienia podstawowego, je\u017celi zmiana Wykonawcy zobowi\u0105zywa\u0142aby Zamawiaj\u0105cego do nabycia materia\u0142\u00f3w o innych w\u0142a\u015bciwo\u015bciach technicznych, co powodowa\u0142oby niekompatybilno\u015b\u0107 techniczn\u0105 albo nieproporcjonalnie du\u017ce trudno\u015bci techniczne w korzystaniu z tych materia\u0142\u00f3w; wykonanie przedmiotu zam\u00f3wienia dodatkowego zale\u017cy od wykonania zam\u00f3wienia podstawowego.\n\nThe Contracting Authority reserves the right to award the Contractor additional contracts not included in the basic contract, the purpose of which is the partial replacement or extension of the materials covered by the original contract or the expansion of ongoing services, with a value not exceeding 50% of the value of the basic contract, where a change of Contractor would oblige the Contracting Authority to acquire materials having different technical characteristics, resulting in technical incompatibility or disproportionate technical difficulties in the use of such materials; the performance of the additional contract shall be dependent on the performance of the basic contract.","terms_of_contract_change":"Warunki zmiany umowy zosta\u0142y uregulowane w rozdziale X. Zapytania ofertowego.\n\n\nThe terms and conditions governing amendments to the Contract are specified in Section X of the Request for Quotation.","created_at":"2026-10-13 12:03:43","modified_at":"2026-10-22 00:00:10","contact_persons":[{"id":59042,"forename":"Ewelina","surname":"Br\u00f3skowska","phone_number":"690 820 452","email":"e.broskowska@poltreg.com","created_by":null,"created_at":"2026-10-26 15:03:00","modified_at":"2026-10-26 15:03:00","modified_by":null}],"orders":[{"id":632844,"estimated_value":null,"order_items":[{"id":711634,"description":"Przedmiotem zam\u00f3wienia jest opracowanie, wytworzenie zgodnie z wymaganiami Europejskiej Dobrej Praktyki Wytwarzania (EU GMP), przeprowadzenie bada\u0144 stabilno\u015bci oraz dostarczenie rekombinowanego lentiwirusa trzeciej generacji przeznaczonego do zastosowa\u0144 badawczo-rozwojowych w ramach projektu \u201eNast\u0119pne generacje lek\u00f3w kom\u00f3rkowych w autoimmunologii\u201d. Zam\u00f3wienie realizowane jest w zwi\u0105zku z projektem wsp\u00f3\u0142finansowanym ze \u015brodk\u00f3w Europejskiego Funduszu Rozwoju Regionalnego w ramach programu Fundusze Europejskie dla Pomorza 2021-2027.\n\nLentiwirus powinien zosta\u0107 opracowany na podstawie sekwencji Gene of Interest (GOI) dostarczonej przez Zamawiaj\u0105cego. Wektor musi by\u0107 niezdolny do replikacji, wytwarzany w \u015brodowisku spe\u0142niaj\u0105cym wymagania poziomu bezpiecze\u0144stwa biologicznego BSL-2 oraz zgodny z wymaganiami Farmakopei Europejskiej i EU GMP. Ka\u017cda partia produktu musi charakteryzowa\u0107 si\u0119 mianem funkcjonalnym nie mniejszym ni\u017c 1\u00d710\u2077 TU/ml i spe\u0142nia\u0107 wymagania jako\u015bciowe dotycz\u0105ce m.in. sterylno\u015bci, poziomu endotoksyn, obecno\u015bci mykoplazmy, integralno\u015bci genomu wirusa oraz pozosta\u0142o\u015bci materia\u0142u biologicznego. Wykonawca zobowi\u0105zany jest do przekazania pe\u0142nej sekwencji ko\u0144cowego wektora wraz z potwierdzeniem prawid\u0142owego wprowadzenia sekwencji przekazanej przez Zamawiaj\u0105cego.\n\nZakres zam\u00f3wienia obejmuje dostarczenie minimum 300 fiolek lentiwirusa w jako\u015bci GMP, o obj\u0119to\u015bci 250 \u00b5l ka\u017cda, w trzech odr\u0119bnych transzach po minimum 100 fiolek. Materia\u0142 musi by\u0107 przechowywany i transportowany w temperaturze nie wy\u017cszej ni\u017c -65\u00b0C, przy wykorzystaniu zwalidowanego procesu transportowego zgodnego z wymaganiami EU GMP i GDP. Ka\u017cdej dostawie musi towarzyszy\u0107 kompletna dokumentacja jako\u015bciowa, w tym certyfikat analizy, raporty z bada\u0144 stabilno\u015bci oraz dokumentacja potwierdzaj\u0105ca prawid\u0142owe warunki transportu.\n\nWykonawca przeprowadzi d\u0142ugoterminowe badania stabilno\u015bci produktu przez okres 48 miesi\u0119cy, a wyniki bada\u0144 b\u0119dzie przekazywa\u0142 Zamawiaj\u0105cemu zgodnie z wymaganiami okre\u015blonymi w dokumentacji post\u0119powania. Zakres zam\u00f3wienia obejmuje r\u00f3wnie\u017c zapewnienie gotowo\u015bci do audytu jako\u015bciowego prowadzonego przez Zamawiaj\u0105cego oraz wsp\u00f3\u0142prac\u0119 w zakresie potwierdzenia zgodno\u015bci procesu wytwarzania z wymaganiami EU GMP.\n\nSzczeg\u00f3\u0142owy zakres zam\u00f3wienia, wymagania techniczne i jako\u015bciowe, parametry produktu, zakres bada\u0144 kontroli jako\u015bci i stabilno\u015bci, warunki transportu i dostaw, wymagania dokumentacyjne oraz terminy realizacji zosta\u0142y okre\u015blone w Zapytaniu ofertowym. W przypadku rozbie\u017cno\u015bci pomi\u0119dzy niniejszym opisem a tre\u015bci\u0105 zapytania ofertowego, wi\u0105\u017c\u0105ce pozostaj\u0105 postanowienia zapytania ofertowego.\n\n\nThe subject of the contract is the development, manufacture in compliance with European Union Good Manufacturing Practice (EU GMP), performance of stability studies, and delivery of a third-generation recombinant lentiviral vector intended for research and development activities within the project \u201cNext-generation cell therapies in autoimmune diseases\u201d. The project is co-financed by the European Regional Development Fund under the European Funds for Pomerania 2021-2027 programme.\n\nThe lentiviral vector shall be developed using the Gene of Interest (GOI) sequence provided by the Contracting Authority. The vector must be replication-incompetent, manufactured in a Biosafety Level 2 (BSL-2) environment and compliant with the requirements of the European Pharmacopoeia and EU GMP. Each batch must achieve a functional titre of at least 1\u00d710\u2077 TU/ml and fulfil quality requirements related to sterility, endotoxin level, absence of mycoplasma, viral genome integrity and residual biological impurities. The Contractor shall provide the complete sequence of the final vector together with confirmation of the correct insertion of the sequence supplied by the Contracting Authority.\n\nThe contract includes the supply of at least 300 GMP-grade lentiviral vector vials, each containing 250 \u00b5l, delivered in three separate batches of at least 100 vials each. The material must be stored and transported at temperatures not exceeding -65\u00b0C using a validated transport process compliant with EU GMP and GDP requirements. Each shipment shall be accompanied by complete quality documentation, including a Certificate of Analysis, stability study reports and documentation confirming compliance with transport requirements.\n\nThe Contractor shall conduct long-term stability studies over a period of 48 months and provide study results to the Contracting Authority in accordance with the requirements specified in the procurement documentation. The scope of work also includes readiness for quality audits performed by the Contracting Authority and cooperation in verifying compliance of manufacturing activities with EU GMP requirements.\n\nThe detailed scope of the contract, technical and quality requirements, product specifications, quality control and stability testing programme, transport and delivery conditions, documentation requirements and implementation schedule are set out in Request for Quotation and its appendices. In the event of any discrepancy between this description and the Request for Quotation, the provisions of the Request for Quotation shall prevail.","warranty_period":null,"cpv_items":[{"id":8514,"code":"73110000-6","name":"Us\u0142ugi badawcze"},{"id":8515,"code":"73111000-3","name":"Laboratoryjne us\u0142ugi badawcze"}],"timetable_items":[],"fulfillment_places":[{"country":"Polska","voivodeship":"pomorskie","poviat":"Gda\u0144sk","commune":"Gda\u0144sk","locality":"Gda\u0144sk","created_by":null,"created_at":"2026-10-13 12:03:43","modified_at":"2026-10-13 12:07:26","modified_by":null,"id":811145,"type":{"id":1,"name":"adres"},"group_uuid":"0468e913-3779-40e8-9a47-0636ecc9722f"}],"participation_conditions":[{"id":2037079,"description":"O udzielenie zam\u00f3wienia mog\u0105 ubiega\u0107 si\u0119 Oferenci, kt\u00f3rzy posiadaj\u0105 uprawnienia do wykonywania okre\u015blonej dzia\u0142alno\u015bci lub czynno\u015bci, je\u017celi przepisy prawa nak\u0142adaj\u0105 obowi\u0105zek ich posiadania. \n\nThe procurement procedure is open to Bidders who possess the licenses, permits, authorizations, or other rights required to carry out the specific activity or service that is the subject of the contract, where such requirements are imposed by applicable legal provisions.","type":{"id":1,"name":"Uprawnienia do wykonywania okre\u015blonej dzia\u0142alno\u015bci lub czynno\u015bci"},"created_by":null,"created_at":"2026-10-13 12:03:43","modified_at":"2026-10-13 12:07:26","modified_by":null,"group_uuid":"009da3f1-d0c8-4c91-9d11-e7f098e83fe6"},{"id":2037080,"description":"O udzielenie zam\u00f3wienia mog\u0105 ubiega\u0107 si\u0119 Oferenci, kt\u00f3rzy posiadaj\u0105 niezb\u0119dn\u0105 wiedz\u0119 i do\u015bwiadczenie.\n\nThe procurement procedure is open to Bidders who have the required knowledge and experience necessary for the proper performance of the contract.","type":{"id":2,"name":"Wiedza i do\u015bwiadczenie"},"created_by":null,"created_at":"2026-10-13 12:03:43","modified_at":"2026-10-13 12:07:26","modified_by":null,"group_uuid":"31fa2777-3dbd-454a-8ac5-fdd657f0b9af"},{"id":2037081,"description":"O udzielenie zam\u00f3wienia mog\u0105 ubiega\u0107 si\u0119 Oferenci, kt\u00f3rzy dysponuj\u0105 potencja\u0142em technicznym.\n\nThe procurement procedure is open to Bidders who have the technical capacity necessary for the proper performance of the contract.","type":{"id":3,"name":"Potencja\u0142 techniczny"},"created_by":null,"created_at":"2026-10-13 12:03:43","modified_at":"2026-10-13 12:07:26","modified_by":null,"group_uuid":"93c032be-81dd-456c-9edd-8287ca325335"},{"id":2037082,"description":"O udzielenie zam\u00f3wienia mog\u0105 ubiega\u0107 si\u0119 Oferenci, kt\u00f3rzy dysponuj\u0105 personelem lub innymi osobami zdolnymi do wykonania przedmiotowego zam\u00f3wienia.\n\nThe procurement procedure is open to Bidders who have at their disposal personnel or other persons capable of performing the subject matter of the contract.","type":{"id":4,"name":"Osoby zdolne do wykonania zam\u00f3wienia"},"created_by":null,"created_at":"2026-10-13 12:03:43","modified_at":"2026-10-13 12:07:26","modified_by":null,"group_uuid":"5683e873-a23b-4c61-831e-a81e46020f6d"},{"id":2037083,"description":"O udzielenie zam\u00f3wienia mog\u0105 ubiega\u0107 si\u0119 Oferenci, kt\u00f3rzy znajduj\u0105 si\u0119 w sytuacji ekonomicznej lub finansowej umo\u017cliwiaj\u0105cej nale\u017cyte wykonanie zam\u00f3wienia.\n\nThe procurement procedure is open to Bidders who are in an economic and financial standing enabling them to duly perform the contract.","type":{"id":5,"name":"Sytuacja ekonomiczna i finansowa"},"created_by":null,"created_at":"2026-10-13 12:03:43","modified_at":"2026-10-13 12:07:26","modified_by":null,"group_uuid":"8f5a0986-fa4d-4832-8d80-57ea7bee840f"},{"id":2037084,"description":"O udzielenie zam\u00f3wienia mog\u0105 ubiega\u0107 si\u0119 Oferenci, kt\u00f3rzy nie podlegaj\u0105 wykluczeniu z post\u0119powania zgodnie z rozdzia\u0142em VI zapytania ofertowego.\n\nThe procurement procedure is open to Bidders who are not excluded from participation in the procurement procedure pursuant to the provisions set out in Section VI of the Request for Quotation.","type":{"id":7,"name":"Dodatkowe warunki udzia\u0142u"},"created_by":null,"created_at":"2026-10-13 12:03:43","modified_at":"2026-10-13 12:07:26","modified_by":null,"group_uuid":"eb89e495-fdf4-4ba2-9a72-b9b0c1a38bb4"},{"id":2037085,"description":"Oferta powinna obejmowa\u0107:\na) formularz ofertowy sporz\u0105dzony zgodnie ze wzorem stanowi\u0105cym za\u0142\u0105cznik nr 1 do niniejszego zapytania,\nb) dokument lub dokumenty niezb\u0119dne do potwierdzenia spe\u0142nienia warunk\u00f3w wymaganych w opisie przedmiotu zam\u00f3wienia,\nc) odpis lub informacj\u0119 z Krajowego Rejestru S\u0105dowego, Centralnej Ewidencji i Informacji o Dzia\u0142alno\u015bci Gospodarczej albo innego w\u0142a\u015bciwego rejestru w celu potwierdzenia, \u017ce osoba dzia\u0142aj\u0105ca w imieniu Oferenta jest uprawniona do jego reprezentowania, chyba \u017ce Zamawiaj\u0105cy mo\u017ce zweryfikowa\u0107 aktualne dane za pomoc\u0105 bezp\u0142atnych i publicznie dost\u0119pnych baz danych, w szczeg\u00f3lno\u015bci rejestr\u00f3w publicznych w rozumieniu ustawy z dnia 17 lutego 2005 r. o informatyzacji dzia\u0142alno\u015bci podmiot\u00f3w realizuj\u0105cych zadania publiczne (tj. Dz.U. z 2020 r. poz. 346, ze zm.). Oferent maj\u0105cy siedzib\u0119 lub miejsce zamieszkania poza terytorium Rzeczypospolitej Polskiej sk\u0142ada dokument lub dokumenty wydane w kraju, w kt\u00f3rym ma siedzib\u0119 lub miejsce zamieszkania,\nd) pe\u0142nomocnictwo do dzia\u0142ania w imieniu Oferenta (je\u017celi dotyczy).\n\nThe Bid shall include:\na) a Bid Form prepared in accordance with the template attached as Appendix No. 1 to this Request for Quotation;\nb) document(s) required to demonstrate compliance with the requirements specified in the Description of the Subject Matter of the Contract;\nc) an extract from, or information contained in, the National Court Register (KRS), the Central Registration and Information on Business (CEIDG), or another relevant register, confirming that the person acting on behalf of the Bidder is authorized to represent the Bidder, unless the Contracting Authority is able to verify such information through free and publicly available databases, in particular public registers within the meaning of the Act of 17 February 2005 on the Computerisation of the Activities of Entities Performing Public Tasks (Journal of Laws of 2020, item 346, as amended). A Bidder having its registered office or place of residence outside the territory of the Republic of Poland shall submit the relevant document(s) issued in the country where it has its registered office or place of residence;\nd) a power of attorney authorizing the person signing the Bid to act on behalf of the Bidder (if applicable).","type":{"id":6,"name":"Lista wymaganych dokument\u00f3w/o\u015bwiadcze\u0144"},"created_by":null,"created_at":"2026-10-13 12:03:43","modified_at":"2026-10-13 12:07:26","modified_by":null,"group_uuid":"377c6a21-5ec9-4642-a246-83878a3b9007"}],"category":{"id":1,"name":"Us\u0142uga"},"subcategory":{"id":4,"name":"Us\u0142ugi badawcze"},"created_by":null,"created_at":"2026-10-13 12:03:43","modified_at":"2026-10-13 12:07:26","modified_by":null,"group_uuid":"f7dae530-dc03-4d81-b3fc-8d536a534bb3"}],"evaluation_criteria":[{"id":1141683,"price_criterion":true,"description":"Kryterium: Cena\nWaga: 100%\nFormu\u0142a:\nPc=Cm/Cx \u00d7waga\nLegenda:\nPc \u2013 liczba punkt\u00f3w przyznanych danej ofercie w kryterium ceny;\nCm \u2013 najni\u017csza cena netto zaoferowana w odpowiedzi na zapytanie;\nCx \u2013 cena netto rozpatrywanej oferty.","created_by":null,"created_at":"2026-10-13 12:03:43","modified_at":"2026-10-13 12:07:26","modified_by":null,"group_uuid":"83b8d010-7baf-4a74-a173-3aed646df5f1"}],"is_variant":false,"title":"Wytworzenie i dostawa lentiwirusa EU GMP","order_node":{"id":476629},"created_by":null,"created_at":"2026-10-13 12:03:43","modified_at":"2026-10-13 12:07:26","modified_by":null}],"created_by":{"id":24272,"contact_persons":[]},"modified_by":{"modified_by":null,"id":1,"contact_persons":[]},"status":{"id":2,"label":"PUBLISHED","name":"Opublikowane"},"advertiser_address_details":{"name":"POLTREG Sp\u00f3\u0142ka Akcyjna","identification_number_type":"nip","identification_number":"9571079577","address":{"country":"Polska","voivodeship":"pomorskie","poviat":"Gda\u0144sk","commune":"Gda\u0144sk","locality":"Gda\u0144sk","created_by":{"id":24272,"contact_persons":[]},"created_at":"2026-10-13 12:03:43","modified_at":"2026-10-13 12:03:43","modified_by":{"id":24272,"contact_persons":[]},"id":1109507,"street":"ul. Botaniczna","number_description":"20 (hala 4)","postcode":"80-298"},"created_by":{"id":24272,"contact_persons":[]},"created_at":"2026-10-13 12:03:43","modified_at":"2026-10-13 12:03:43","modified_by":{"id":24272,"contact_persons":[]},"id":391772},"advertisement":{"id":294682,"number":"2026-24272-294682","publication_date":"2026-10-13","created_by":{"id":24272,"contact_persons":[]},"created_at":"2026-10-13 12:03:43","modified_at":"2026-10-22 00:00:10","modified_by":{"modified_by":null,"id":1,"contact_persons":[]},"status":{"id":6,"label":"RESOLVED","name":"Rozstrzygni\u0119te"},"all_available_version_ids":[390693],"enrollment":null,"projects":[{"id":73927,"name":"Nast\u0119pne generacje lek\u00f3w kom\u00f3rkowych w autoimmunologii","number":"0017/25","activity":{"created_by":{"modified_by":null,"id":89,"contact_persons":[]},"created_at":"2023-02-22 13:14:26","modified_at":"2023-02-22 13:14:26","modified_by":{"modified_by":null,"id":89,"contact_persons":[]}},"region":null,"institution":{"created_by":{"modified_by":null,"id":89,"contact_persons":[]},"created_at":"2023-02-23 10:13:08","modified_at":"2023-02-23 10:13:08","modified_by":{"modified_by":null,"id":89,"contact_persons":[]}},"full_number":"FEPM.01.01-IZ.00-0017/25","perspective":{},"programme":{"created_by":{"modified_by":null,"id":89,"contact_persons":[]},"created_at":"2023-02-22 13:13:05","modified_at":"2023-02-22 13:13:05","modified_by":{"modified_by":null,"id":89,"contact_persons":[]}},"priority":{"created_by":{"modified_by":null,"id":89,"contact_persons":[]},"created_at":"2023-02-22 13:13:22","modified_at":"2023-02-22 13:13:22","modified_by":{"modified_by":null,"id":89,"contact_persons":[]}},"type":"project","created_by":{"id":24272,"contact_persons":[]},"created_at":"2026-07-31 13:02:37","modified_at":"2026-07-31 13:02:37","modified_by":{"id":24272,"contact_persons":[]}}],"is_author":false,"is_admin":false},"attachments":[{"origin":{"id":390693,"publication_date":"2026-10-13"},"id":2825680,"name":"Zapytanie ofertowe_2_2026_CARTREG_PL_13.10.2026.pdf","file":{"id":3135868,"name":"Zapytanie ofertowe_2_2026_CARTREG_PL_13.10.2026.pdf","created_at":"2026-10-13 12:06:12","created_by":{"forename":"Ewelina","surname":"Br\u00f3skowska"},"uri":"/api/files/3135868"},"group_uuid":"8f584b23-2e61-44a9-b6e5-34088c1e83b0"},{"origin":{"id":390693,"publication_date":"2026-10-13"},"id":2825681,"name":"Request for Quotation_2_2026_CARTREG_ENG_13.10.2026.pdf","file":{"id":3135871,"name":"Request for Quotation_2_2026_CARTREG_ENG_13.10.2026.pdf","created_at":"2026-10-13 12:06:19","created_by":{"forename":"Ewelina","surname":"Br\u00f3skowska"},"uri":"/api/files/3135871"},"group_uuid":"125d278b-e52e-4985-b8b7-b9692f121246"},{"origin":{"id":390693,"publication_date":"2026-10-13"},"id":2825682,"name":"Formularz ofertowy_2_2026_CARTREG_PL_13.10.2026.docx","file":{"id":3135873,"name":"Formularz ofertowy_2_2026_CARTREG_PL_13.10.2026.docx","created_at":"2026-10-13 12:06:25","created_by":{"forename":"Ewelina","surname":"Br\u00f3skowska"},"uri":"/api/files/3135873"},"group_uuid":"84036e6d-c4c6-45ec-84fc-09e2218d1628"},{"origin":{"id":390693,"publication_date":"2026-10-13"},"id":2825683,"name":"Offer Form_2_2026_CARTREG_ENG_13.10.2026.docx","file":{"id":3135874,"name":"Offer Form_2_2026_CARTREG_ENG_13.10.2026.docx","created_at":"2026-10-13 12:06:31","created_by":{"forename":"Ewelina","surname":"Br\u00f3skowska"},"uri":"/api/files/3135874"},"group_uuid":"680faa11-f4b0-4deb-b3b3-e60b5cb89a74"}]},"dictionaries":{"announcement_status_draft":1,"announcement_status_published":2},"favorite":null,"badge":null,"offer_set_badge_count":null,"question_badge_count":null}}