Vaccine Development Excellence
What we can do
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Facility & Process Design (CAPEX-ready)
Draft design review, segregation strategy, cleanroom/HVAC concepts, equipment URS, and commissioning readiness — built around QRM/CCS principles.
A
Strategy & Feasibility
Feasibility study / roadmap
Target Product Profile / CMC strategy
Budget & timeline model
Regulatory pathway map (vet/human)
Deliverables
10–30 стр + Gantt + risk register
B
Engineering & GMP Readiness
Audit draft design (layout, flows, zoning, HVAC concepts, segregation)
URS packages (bioreactors, HVAC, WFI/clean steam, lyophilizer, fill-finish)
FAT/SAT protocols, commissioning support
Validation readiness package (VMP outline, IQ/OQ approach)
Deliverables
URS/RA/CCS
Ready to discuss your CAPEX project?
Our experts will help you navigate facility design, equipment selection, and regulatory readiness.
Upstream & Downstream Optimization (USP/DSP)
Yield, robustness, and throughput improvements for egg-based and cell-culture processes, including scale-up logic, hold times, and contamination risk reduction.
Lab
Research & Development
Pilot
Process Validation
Commercial
Full-Scale Production
A
Process & Product
Process development, scale-up strategy
Inactivation and hold-time strategy
Formulation & adjuvant selection (vet/human)
Tech transfer package, MBR/BPR templates
QC assays mapping and control strategy
Deliverables
Optimize your vaccine production process
Let's discuss how we can improve your yield, reduce contamination risks, and streamline your USP/DSP operations.
Tech Transfer & Scale-Up
Structured transfer packages from lab/pilot to commercial — practical, defensible, and audit-ready.
Lab
Research & Development
Pilot
Process Validation
Commercial
Full-Scale Production
Process descriptions (lab → pilot → commercial)
CPP/CQA mapping (critical process parameters / critical quality attributes)
Training packages for production and QC teams
Batch documentation templates (MBR/BPR)
Execution support during scale-up
GMP Compliance & QA/QC Systems
Gap assessments, CAPA plans, documentation systems, deviation management, and inspection readiness — aligned with global GMP standards.
Gap Assessments
Comprehensive audits of facility, process, and documentation against global GMP standards
CAPA Plans
Corrective and Preventive Actions planning and implementation tracking
Documentation Systems
GDocP-compliant documentation frameworks and standard operating procedures
Deviation Management
Workflows for identification, investigation, and resolution of deviations
Environmental Monitoring
EM strategy alignment with cleanroom classification and risk assessment
Inspection Readiness
Preparation support for regulatory audits and inspections
Formulation & Adjuvant Strategy
Formulation pathways that fit your target product profile, manufacturing constraints, and supply chain — without 'magic ingredients'.
Formulation Pathways
Development of formulation pathways for veterinary and human vaccines tailored to your target product profile
Adjuvant Selection
Strategic adjuvant selection aligned with product profile and regulatory requirements
Training & Operational Excellence
Targeted training for production, QC, QA, and engineering teams — practical, audit-proof, and tailored to your platform.
GMP Training
Comprehensive GMP fundamentals for production teams, covering cleanroom behavior, contamination control, and batch record management
GDocP Training
Documentation excellence training including SOPs, batch records, logbooks, and audit trail management
Deviations & CAPA
Workflow training for deviation identification, investigation, root cause analysis, and CAPA implementation
BSL Workflows
Biosafety Level protocols, containment strategies, risk assessment, and emergency response procedures
Let's discuss your vaccine project — from Lab to Jab.
Tell us what you're building and where you are today. We'll respond with the fastest path to a defensible plan.
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Vaccine Development & Manufacturing Consulting
From concept to GMP-ready production
From concept to GMP-ready production
Confidential. No magic, no unrealistic timelines, no NDA breaches.
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