Purchase and delivery of services

ZF Polpharma S.A.

1. Optional: Feasibility studies with non-/GMP material, Quantity: approx. 3 batches.
2. GMP Manufacturing of liquid biological drug product in vials for clinical trials. Quantity up to 5 batches.
3. Optional: Manufacturing process validation. Quantity: N/A.
4. Optional: GMP Manufacturing of liquid drug product in vials for clinical trials — extra batches. Quantity: up to 3 batches.
Time-lines for execution of the order:
1. Within August-November 2016:
2. Within November 2016-December 2017;
3. In 2017 or in 2018 — exact date depends on previous project steps outcomes;
4. In 2018 — exact date depends on previous project steps outcomes.

Termin

Termin składania ofert wynosił 2016-08-06. Zamówienie zostało opublikowane na stronie 2016-06-22.

Kto?

• ZF Polpharma S.A.

Co?

• Usługi w zakresie zdrowia i opieki społecznej

Gdzie?

• Polska

Historia zamówień

Data	Dokument
2016-06-22	Ogłoszenie o zamówieniu
2016-07-15	Dodatkowe informacje

Ogłoszenie o zamówieniu (2016-06-22)
Obiekt
Zakres zamówienia
Tytuł: Usługi w zakresie zdrowia i opieki społecznej
Metadane ogłoszenia
Język oryginału: angielski 🗣️
Typ dokumentu: Ogłoszenie o zamówieniu
Rodzaj zamówienia: Usługi
Regulacja: Unia Europejska
Wspólny słownik zamówień (CPV)
Kod: Usługi w zakresie zdrowia i opieki społecznej 📦

Procedura
Typ procedury: Procedura otwarta
Typ oferty: Wniosek dotyczący wszystkich partii
Kryteria przyznawania nagród
Oferta najbardziej korzystna ekonomicznie

Instytucja zamawiająca
Tożsamość
Kraj: Polska 🇵🇱
Typ instytucji zamawiającej: Inne
Nazwa instytucji zamawiającej: ZF Polpharma S.A.
Adres pocztowy: ul. Pelplińska 19
Kod pocztowy: 83-200
Miasto pocztowe: Starogard Gdański
Kontakt
Adres internetowy: http://www.polpharma.com 🌏
E-mail: katarzyna.geller@polpharma.com 📧
Telefon: +48 785877707 📞

Odniesienie
Daty
Data wysłania: 2016-06-22 📅
Termin składania ofert: 2016-08-06 📅
Data publikacji: 2016-06-25 📅
Identyfikatory
Numer ogłoszenia: 2016/S 121-216964
Numer Dz.U.-S: 121

Obiekt
Zakres zamówienia
Krótki opis:

1. Optional: Feasibility studies with non-/GMP material, Quantity: approx. 3 batches.

2. GMP Manufacturing of liquid biological drug product in vials for clinical trials. Quantity up to 5 batches.

3. Optional: Manufacturing process validation. Quantity: N/A.

4. Optional: GMP Manufacturing of liquid drug product in vials for clinical trials — extra batches. Quantity: up to 3 batches.

Time-lines for execution of the order:

1. Within August-November 2016:

2. Within November 2016-December 2017;

3. In 2017 or in 2018 — exact date depends on previous project steps outcomes;

4. In 2018 — exact date depends on previous project steps outcomes.

Nazwa projektu lub programu finansowanego przez UE:

Purpose of the order: Aim of the Continuation of studies in the framework of the project ‘The development of innovative technology for producing monoclonal antibody for the treatment of multiple sclerosis’ Action 1.1 ‘R and D Projects’ within I priority axis: ‘Support for R and D works by the enterprises’ Operational Programme Smart Development, 2014-2020.

Miejsce wykonania
Główne miejsce lub miejsce wykonywania działalności: Polpharma Biologics, ul. Trzy Lipy 3 bud. A, 80-172 Gdańsk.

Informacje prawne, ekonomiczne, finansowe i techniczne
Realizacja zamówienia
Inne szczególne warunki:

Details on the project will be revealed after signing CDA:

— Personnel capable of performing the order: The order cannot be granted to the parties related with the Buyer personally or financially. Through personal or financial relations means the connections between the beneficiary or persons authorized to enter into commitments on behalf of the beneficiary or persons who preform, on behalf of the beneficiary, the activities related to the preparation and carrying out the procedure for the supplier selection and supplier, in particular: — Participation in the company as a partner or partnership, — Possession of at least 10 % of shares, — Member of supervisory or management board, proxy, — Remaining married, in consanguinity or affinity in a straight line, or 2

Project delay's consequences will be defined in a contract. Other required documents or other criteria:

"Part 1:

'Must Have' Requirements — Successful supplier shall:

1. Have experience with manufacturing of liquid protein drug product (how many such batches manufactured in the last 5 years?);

2. Use single-use (SU) disposable consumables in the filling process for contact with protein (how many such batches manufactured in the last 5 years?);

3. Assure aseptic filling process (how many such batches manufactured in the last 5 years?);

4. Conduct the service in Drug Product manufacturing site located in Europe;

5. Conduct the service in the manufacturing site that is GMP certified for production of drug material for clinical trials ACC to GMP Rules; the certification shall be granted at least by a local Regulatory Authority;

6. Use peristaltic pumps for the filling process;

7. Provide 100 % visual inspection of the filled containers;

8. Sign Confidentiality Agreement with Polpharma;

9. Agree to receive site-visit and supplier qualification audit;

10. Have ability to aseptically fill parenteral biological batches of 10-60L;

11. Sign Quality Agreement next to the Service Contract under European law;

12. Propose the filling process compatible with with Buyer's chosen primary packaging;

13. Ideally, have already experience with filling the specific drug highly similar to the 1 of Polpharma, or to conduct feasibility studies (e.g. non-/GMP extra batches) before the filling for clinics;

14. Able to transfer the carried Drug Product manufacturing process to commercial scale even to another company);

15. Assure sterile filtration 2 times before filling;

16. Be able to provide technical (limited scope) QP Release of the manufactured GMP drug product batches.

Company that fulfils all the above requirements is kindly invited to send application containing: GMP certificate and statement containing answers to all the above requirements. CDA template will be then promptly sent to you, or you may propose yours.

If any of the requirement cannot be fulfilled but you could propose a solution, please send inquiry."

"Part 2:

Upon CDA is signed and based on detailed service requirements provided by Buyer — company shall provide Quote including all costs that are related to the required service, including consumables, project management, customs duty etc. "

"ad. Part 2:

Other Requirements:

Upon CDA is signed — response to below points shall be provided:

— The manufacturing project should be preceded by risks assessment and mitigation plan, in cooperation with Buyer;

— The manufacture should be accompanied by:

— Media Fill Test (MFT), primary packaging release and preparation (depyrogenization, sterilization), In-Process Control (IPC) and final drug product testing, bulk secondary packaging, cold storage drug product in bulk, cold storage (what capacity?) and shipment of drug product filled (incl. transport validation), filter validation;

— Advantageous if company could provide also commercial manufacturing of the same material. Are you able to produce commercial batches of min. 120L and max 200L;

— State flexibility in filling slot reservation: How much in advance informed? Possibility to shift? Cost of slot shift;

— Experience in aseptic fill and finish service for liquid protein/protein-based drug products;

— Experience with filling liquid protein/protein-based drug products peristaltic pumps;

— Is MFT for the filling our batches already available in the site;

— How class A is assured for the filling process;

— Are particles continuously controlled during the process? How? methods used;

— What are your usual actions in case the final filled product does not meet specification? (procedure in place?);

— How are you usually managing any other deviations? How and how quickly do you communicate them to client;

— What are the usual ranges (min./max.) of product loss during manufacturing of ca. 60L protein batch;

— If you cooperate with subcontractors for our project — for which parts? are they all qualified/verified.

"Part 3 — Visits:

1. Company chosen based on all the received information shall accept site-visit (quality and technical) — even before supplier selection process is finalized, or shortly after;

2. Successful supplier qualification audit has to precede start of the service."

Exclusions: For the offers evaluation there will be taken into consideration only offers that meets the whole requirements defined in points "Order subject” and “Additional conditions”. The Buyer has the right to reject the offer, if the offer is incomplete or incompatible to offer request.

Procedura
Okres ważności oferty: 2018-12-31 📅
Data otwarcia ofert: 2016-08-08 📅
Kryteria przyznawania nagród
Kryterium: 1. Quality-related (60)
2. Price (25)
3. Experience (10)
4. Cooperativeness (5)
Języki
Język: angielski 🗣️
polski 🗣️

Instytucja zamawiająca
Tożsamość
Krajowy numer rejestracyjny: NIP PL5920202822
Inny rodzaj instytucji zamawiającej: Other
Kontakt
Punkt kontaktowy: Polpharma Biologics
Katarzyna Geller
Adres internetowy: www.polpharma.com 🌏
Adres profilu nabywcy: www.polpharma.com 🌏
URL do udziału: https://bazakonkurencyjnosci.funduszeeuropejskie.gov.pl/ 🌏
URL dokumentów: https://bazakonkurencyjnosci.funduszeeuropejskie.gov.pl/ 🌏
Źródło: OJS 2016/S 121-216964 (2016-06-22)

Dodatkowe informacje (2016-07-15)
Obiekt
Metadane ogłoszenia
Typ dokumentu: Dodatkowe informacje

Odniesienie
Daty
Data wysłania: 2016-07-15 📅
Data publikacji: 2016-07-20 📅
Identyfikatory
Numer ogłoszenia: 2016/S 138-250622
Odnosi się do ogłoszenia: 2016/S 121-216964
Numer Dz.U.-S: 138
Źródło: OJS 2016/S 138-250622 (2016-07-15)

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