Search results - 18 results

OCABR: Respiratory Syncytial Virus (rDNA) Vaccine

p.15 (2023) Accession Number: PA/PH/OMCL (23) 3 DEF Keywords: EDQM guideline OCABR RSV Health Topics:  Vaccine batch conformity Vaccin lot conformiteit Conformité de lot de vaccin Service:  Qualité des ...

Validation of an animal-free analytical method for the detection of bacterial endotoxins in human vaccines

“Official Control Authority Batch Release” (OCABR) guidelines, is entitled to check the concentration of endotoxin in bacterial vaccines. The limulus amebocyte lysate (LAL) and the recombinant factor C (rFC) ...

Determination of vaccine bacterial endotoxins content by the rFC method

factor c; LAL Abstract: Sciensano, as official medicines control laboratory (OMCL) following “Official Control Authority Batch Release” (OCABR) guidelines, is entitled to check the concentration of ...

OCABR guideline for inactivated COVID-19 vaccines

p.12 (2022) Accession Number: PA/PH/OMCL (22) 95 DEF Keywords: COVID-19 EDQM inactivated vaccine OCABR Service:  Qualité des vaccins et produits sanguins Kwaliteit van vaccins en bloedproducten Quality ...

Proposal for 3R reporting for Official Control Authority Batch Release

Publication Type: Scientific poster, presentation or proceeding Authors: Source: OMLC Annual meeting 2021- Common OCABR session, EDQM (extranet), Strasbourg, France (2021) Keywords: 3Rs EU reporting ...

RSV vaccine GSK: OCABR testing

Publication Type: Scientific poster, presentation or proceeding Authors: L. Tesolin Source: EDQM OCABR drafting group, EDQM, EDQM, Strasbourg (2021) Keywords: OCABR RSV TESTING Health Topics:  ...

OCABR of Covid vaccines, a success story

Publication Type: Scientific poster, presentation or proceeding Authors: Geneviève Waeterloos; Catherine Milne Source: Annual OMCL meeting_ General session, Issue EDQM (2021) Health Topics:  Effectiveness and safety of vaccines, medicines and health produ ...

Guideline for Pandemic COVID-19 Vaccine (mRNA)

Publication Type: Sci. report, recommendat°, guidance doc., directive, monograph Authors: L. Tesolin; EDQM OCABR drafting group Source: EDQM, EDQM, strasbourg, p.16 (2021) Accession Number: ...

Guideline for Pandemic COVID-19 Vaccine (Non-replicating Adenovirus-vectored vaccine)

Publication Type: Sci. report, recommendat°, guidance doc., directive, monograph Authors: L. Tesolin; EDQM OCABR drafting group Source: EDQM, EDQM, strasbourg, p.13 (2021) Accession Number: ...

Batch release of vaccines in Europe: from method transfer to first commercial batch available on the market. Straightforward approach that requires a proactive mind-set of the manufacturer.

Certificate when the results are satisfactory. This is known as “Official Control Authority Batch Release” (OCABR) and consists of analytical controls and document review which are additional to the routine ...

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