Purchase and delivery of stability studies of drug product and drug substance

Z.F. Polpharma S.A.

1. Stability studies for drug product and drug substance- approx. 5 studies.
2. Method development for specific monoclonal Ab- up to 7 methods.
3. Method validation for stability studies and release — up to 8 methods.
4. Acting as backup release DP site.
Lp.1. start November 2016 till November 2018 (long term stability studies).
Lp.2. November onwards 2016.
Lp.3. November onwards 2016.
Lp.4. in 2017 — exact date depends on previous project steps outcomes.
Project's delay consequences will be defined in a contract.
Details on the project will be revealed after signing CDA.
Part 1
'must have' Requirements — Successful supplier shall:
1. Have experience with analytical development and stability studies for specific monoclonal Ab and other biosimilars
2. Have experience in performing stability studies, long term studies, leachable and extractable studies on multiple biosimilars
3. Conduct stability trials in Europe
4. Have fully established GMP environment and certification and have prior experience with positive FDA audits in last 5y
5. Be able to serve as backup release site for DS and DP
6. Have experience in method development, qualification and validation for at least more than 15y
7. Prior experience with method development and qualification for specific mAb
8. Have at lest 10y experience with GMP compliant mass spectrometry of proteins.
9. FDA compliant long term storage facility including backup storage service. Customer protected via insurance policy.
10. Possibility to support Polpharma with regards to registration and file submission of the product
11. Commitment to instal dedicated team of at least 4 FTEs to support all activities connected with Polpharma project
12. Sign Confidentiality Agreement with Polpharma
13. Agree to receive site-visit and supplier qualification audit
14. Sign Quality Agreement next to the Service Contract under European law.
Company that fulfills 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:
— State flexibility in slot reservation: How much in advance informed? Possibility to shift? Cost of slot shift?
— Experience in designing of stability protocols
— Experience in DS and DP release
— What are your usual actions in case of OOS? (procedure in place?)
— How are you usually managing any other deviations? How and how quickly do you communicate them to client?
— If you cooperate with subcontractors for our project — for which parts? are they all qualified/verified?
— Please provide audit history (local GMP and FDA)
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.

Termin
Termin składania ofert wynosił 2016-11-14. Zamówienie zostało opublikowane na stronie 2016-09-27.

Dostawcy
Następujący dostawcy są wymienieni w decyzjach o przyznaniu zamówienia lub innych dokumentach dotyczących zamówień:

• • A&M Stabtest GmbH

Kto?

• • Z.F. Polpharma S.A.

Co?

• • Usługi w zakresie zdrowia i opieki społecznej › Usługi ochrony zdrowia