Biovac
The Expansion Pathway

From 150M to 560M Doses, De-Risked

Biovac's integrated expansion platform — from fill-and-finish to end-to-end drug substance manufacturing. Configure your pathway below.

Manufacturing Evolution

From Fill-and-Finish to End-to-End

Biovac's strategic transition from imported drug substance to local end-to-end manufacturing — fermentation, purification, conjugation, formulation, filling, and distribution.

Hexavalent
Sanofi
Import DS Fill & Finish End-to-End
Operational — DS imported
PCV13 (Prevenar)
Pfizer
Import DS Fill & Finish End-to-End
Operational — DS imported
COVID-19 mRNA
Pfizer/BioNTech
Import DS Fill & Finish End-to-End
Operational — DS from EU
Oral Cholera Vaccine
IVI
Import DS Fill & Finish End-to-End
First E2E Product
mRNA Platform
WHO Hub / Afrigen
Import DS Fill & Finish End-to-End
Building capability
Meningococcal
EuBiologics
Import DS Fill & Finish End-to-End
MOU Stage
Manufacturing Intelligence

Manufacturing Command Center

Powered by the BVC Proprietary Cryptographic Ledger. Projected manufacturing timelines are secured by automated compliance routing and zero-latency batch validation. Edge-delivered with SAHPRA Annex 11-aligned data integrity.

biovac://manufacturing-command-center AWAITING CONFIGURATION
Accelerated Timeline Projection
Tech Transfer Clinical Scale Commercial Validation
Select parameters above to
generate timeline projection
Validation Telemetry Log
Compliance verification
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Phase 2
PREDICTIVE MANUFACTURING INTELLIGENCE

AI-Driven Facility Monitoring

Predictive analytics for cleanroom environmental control, cold chain integrity, and bioprocess optimisation. Available with Consortium Dashboard implementation.

Cleanroom ΔP
ISO 5/7 Cascade
HVAC Particles
ISO 14644
ULT Freezers
-70°C mRNA
Bioreactor Env
pH / DO₂ / Temp

SADC & UNICEF Distribution Matrix

Real-time cold chain distribution intelligence across South Africa's nine provinces and six SADC partner countries. GDP-compliant temperature integrity monitoring from Cape Town to the last mile.

biovac://sadc-distribution-matrix
59M TOTAL DOSES
South Africa HUB
30M doses
Mozambique
8M
Zimbabwe
6M
Zambia
5M
Malawi
4M
Botswana
3M
Namibia
2M
eSwatini
1M
Cape Town Hub → SADC Partner Countries • GDP-Compliant Cold Chain 2-8°C / -20°C / -70°C TIERS
0
Annual Doses Distributed
0
SA Provinces Served
0
Countries in Network
0
Cold Chain Temperature Tiers
Our Process

Embedded Expertise at Every Phase

Regulatory compliance and quality assurance built into the foundation, turning potential hurdles into milestones.

01

Tech Transfer & Process Development

Our dedicated MSAT team ensures seamless onboarding. We proactively identify regulatory CQAs (Critical Quality Attributes) from day one, designing a process that is robust, scalable, and compliant by design.

MSAT TEAM CQA IDENTIFICATION DoE OPTIMIZATION
02

Clinical Manufacturing

Operating under a single, fortified QMS with complete data integrity and batch records ready for regulatory submission (IND, CTA). Our embedded QA team oversees every step, accelerating your path to the clinic.

cGMP COMPLIANT EMBEDDED QA IND/CTA READY
03

Commercial Scale & Lifecycle Support

Facilities built for successful PAI (Pre-Approval Inspection) with ongoing regulatory support for post-market activities, including variation filings and lifecycle management. A true end-to-end partnership.

PAI READY POST-MARKET SUPPORT LIFECYCLE MGMT

Schedule Your Technical Consultation

Speak directly with a partnership expert to architect your definitive project plan with Biovac.