Innovations to accelerate vaccine development and manufacture - Annual Meeting 2023 - Standard Operating Procedure (SOP) template - WP12

Sep 12, 2026

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A Standard Operating Procedure (SOP) template focused on routine experimental operations to accelerate vaccine development and manufacture. Content defines SOP goals and core principles, clarifies procedure scope, acceptance criteria, and limits or exceptions. It contrasts experimental protocols with SOPs, outlines required sections such as result validation, calculations, and references, and specifies roles for authors, approvals, and responsibility. It also provides examples for controls, ELISA criteria, and vaccine batch release evaluation using defined acceptance rules.

LanguageEnglish

CategoryPresentations

FormatPDF

Pages14

Reading Time5 min

AccessFree to download

What is an SOP?

Define goals and general principles

Provide step-by-step routine instructions

Scope, limits, and exceptions

Roles: writing, approval, responsibility

Why do you need an SOP?

Example of unclear procedure

Experimental protocol vs. SOP

SOP: Table of contents

Result validation

Calculations

References

Acceptance criteria and validation examples

Blanks and positive/negative controls

Criteria for cell characterization

ELISA batch release evaluation rules

Results evaluation/approval process

Innovations to accelerate vaccine development and manufacture Annual Meeting 2023 Standard Operating Procedure (SOP) template WP12 Sciensano Maxime Vermeulen-Alexandre Dobly-Lorenzo Tesolin This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 101007799. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. The views and opinions expressed in this presentation are those of the author(s) and do not necessarily reflect the official policy or position of Sciensano organization What is an SOP ? Define the goals of the SOP and the general principle of the experiment Provide clear step by step instructions for routine operations Explain the range of activities to which the SOP apply and the limits/exceptions to which it does not Specificy who participated in the writing of the document, who approved the final version/change (revision history), and who is in charge of what in the procedure Why do you need an SOP? Example of unclear procedure Isolation of human SSCs from OA patients Sun, M., et al. Efficient generation of functional haploid spermatids from human germline stem cells by three-dimensional-induced system. Cell Death Differ (IF=13.3), 2018 Experimental protocol vs. SOP SOP: Table of contents 8. Result validation 9. Calculations 10. References Explain the acceptance criteria to whom the results should answer and methodology to set them e.g. clinical relevance, statistical analysis… Criteria can be established for the cell characterization e.g. genes or cell markers expression to confirm the state of differentiation Acceptance criteria can depend on the output analysis e.g. cytokine secretion pre/post infection, detection of pathogen amplification, inhibition of replication following antisera or neutralizing antibody Blanks, positive and negative controls should be established Describe the calculations leading to results and if applicable the software used Explain the norms and references on which the methods rely e.g. standardized methods/protocols, scientific articles, in-house SOP, international guidelines, Pharmacopeia… Example of criteria for an ELISA HepB antigen titration for vaccine batch release Results evaluation/approval: 1. Standard curve a) R2 ≥ 0.95 b) OD80 – OD20 ≥ 1 c) Intradilution CV ≤ 20% d) At least 3 dilution points between OD80 and OD20 e) -3SD ≤ Slope ≤ +3SD (of established specifications) 2. Internal control a) Titer determined with at least 3 valid values (comprised between OD80-OD20) b) Interdilution CV ≤ 20% c) -3SD ≤ titer ≤ +3SD (of established specifications) 3. Samples a) Titer determined with at least 3 valid values (comprised between OD80-OD20) b) Interdilution CV ≤ 20%

FAQs

What is the purpose of an SOP in this presentation?

An SOP defines goals and general principles, provides clear step-by-step instructions for routine operations, and specifies the scope, limits, and exceptions of the procedure.

How does an SOP differ from an experimental protocol?

The presentation distinguishes SOPs as structured, routine-operation instructions with defined acceptance criteria and responsibilities, whereas experimental protocols focus on executing experiments within a study context.

What acceptance criteria are used in the ELISA example for vaccine batch release?

The example lists requirements for the standard curve (e.g., R2 thresholds and OD80–OD20 separation), internal controls (e.g., titer ranges and CV limits), and sample evaluation (including valid dilution values and interdilution CV limits).

Sep 12, 2026

Upload by Oliver