In Year 1 sufficient supplies of Ad26.ZEBOV and MVA-BN-Filo have been manufactured and released to the clinical program covered under EBOVAC 1 and 2, including any Health Authority submission packages (CMC).
Vialed product has been manufactured in excess (>1M vials of both Ad26.ZEBOV and MVA.BN.Filo) that can be rapidly accessed for any emergency needs.
Capacity is being made available for further manufacturing.
Meanwhile further improvements of process understanding and optimization did start and continued in Year 2.
In Year 2 focus was on completing activities on Ad26.ZEBOV and MVA-BN-Filo covered under this grant in addition to applying for Emergency Use Assessment Listing (EUAL).
Capacity increase for filling was progressed for completion in Year 3.
With sufficient supplies in stock, EBOMAN has continued to deliver clinical material for studies run under EBOVAC 1 and 2.
During year 3, the main focus was on completing task 4.3 "Fill & Finish capacity extension", a primary task of Vibalogics.
This included some tests and modifications concerning the new fill and finish line: preliminary work concerning the expected supply and implementation of the labelling machine, followed by the delivery, implementation, validation and qualification of the labelling machine.
To close out Work Package 2, A summary report covering the studies performed under Task 2.6 (MVA-BN(r)-Filo Drug Substance - Manufacturing Process Development and transfer) was finalised and submitted.
It was concluded that current process parameter settings were shown to be adequate for processing of MVA-BN(r) Filo and therefore no changes were introduced to the large-scale process.
Under Task 2.8 (MVA-BN(r)-Filo Drug Substance Product characterization and comparability) the summary report was submitted.
The comparability report (Comparability and Characterization of MVA- BN(r)-Filo Bulk Drug Substance) s ummarized the results from characterization of the MVA-BN(r)-Filo
Bulk Drug Substance (BDS) batches manufactured at Bavarian Nordic A/S and Final Drug Product (FDP) batches manufactured at IDT Biologika GmbH (IDT), Dessau, Germany.
The characterization analysis was performed to gain additional knowledge of the product moving forward in clinical trials and to support future comparability assessments of the MVA-BN(r)-Filo BDS.
