Workpackage 5

 

Work package number

5

Start date or starting event:

M12

Work package title

GMP Manufacture

Activity Type[1]

DEM

Participant number

1

3

4

6

 

 

 

Participant short name

IQUR

LBMC

UCL

3P

 

 

 

Person-months per participant:

2.0

2.0

1.8

94.9

 

 

 

                   

 

Objectives

The selected clone will be expanded under non-GMP conditions and tested for scalability. Once achieved, this will be transferred to our contract manufacturer and a master cell bank (MCB) will be prepared followed by a working cell bank (WCB). Finally, a GMP compliant batch of material will be prepared.

 

Description of work (possibly broken down into tasks), and role of participants

Lead candidate VLP will be transferred to 3P for scale-up and GMP manufacture. This is a prerequisite for future clinical studies. This work will occur in two phases; one non-GMP and one GMP.

 

Task 5.1: Technical transfer (3P, UCL, LBMC, M12_M24)

The starting material for this phase will be the Research Cell Bank (RCB) generated and characterised. IQUR, LBMC and UCL will transfer to 3P all existing documentation for the manufacture and analytics of tandem core. These will include procedures and records to facilitate the understanding of the process and its variables. Transfer of intellectual property and reagents will be under a Material Transfer Agreement (MTA) that will form part of the consortium agreement.

3P will prepare a technical transfer (TT) document split and will perform a Biosafety Evaluation as well as an RCB testing to ensure cell banks optimal conditions.

A Tech transfer run (10L) at the sending facility will be performed by 3P to gain a solid knowledge of the process. Furthermore, 3P will carry out one Tech Transfer run and one engineering run in its facilities with the goal of adjusting parameters to the process in its facilities.

Finally, extended head to head comparability studies between the material generated at 3P and the material generated at the sending facilities will be performed.

It is assumed that no optimisation will be required to the process or analytical methods that will be transferred to 3P since these will be developed in WPs 1 and 2.

 

Task 5.2: Generation and Characterisation of Master and Working Cell Bank (MCB-WCB) (3P, M24-M29)

3P will generate 200 vials of MCB and WCB under GMP conditions. GMP characterisation of MCB/WCB will be outsourced and performed according to phase I requirements.

 

Task 5.3: Non-GMP run (3P, M24-M27)

3P will perform scale-up and non-GMP production at 100L. Moreover, a Reference standard will be generated for one of these batches.

 

Task 5.4: Seroconversion and analytics (IQUR/UoL, M27-M28)

Samples from the non-GMP batch will be sent to IQUR for preclinical testing (seroconversion as described in WP 3.1). Concurrently, samples will be sent to UoL for analysis as described in WP2. Successful completion of both studies will act as the go-no-go point for vaccine manufacture.

 

Task 5.5: GMP run (3P, M24-M30)

3P will perform the validation of the analytical methods developed and transferred adequate for Phase I clinical trials.

Next, 3P will manufacture one GMP batch in 100L to obtain material for Phase I trials.

 

Task 5.6: Fill/finish (3P [s/c], M30-M32)

Final vials prepared. Material will be returned to 3P for product release by a Qualified Person (QP).

 

 

Deliverables** (brief description and month of delivery)

 

D 5.1: Technical transfer documentation (M24)

D 5.2: MCB and WCB generated and fully characterised (M29)

D 5.3: material made available for (a) preclinical toxicology (b) seroconversion and (c) structural analysis (M28)

D 5.4: GMP compliant batch release report (M32)



[1]   Please indicate one activity per work package: RTD = Research and technological development; DEM = Demonstration; MGT = Management of the consortium; OTHER = Other specific activities, if applicable (including any activities to prepare for the dissemination and/or exploitation of project results, and coordination activities).