End-to-end plasma services

Bilingual GMP services tailored to your molecule

Design, scale, and release plasma-derived therapeutics with a Canadian partner who integrates manufacturing, QC, and regulatory pathways.

Bioprocess manufacturing backbone

Flexible production suites licensed for commercial distribution in Canada, Europe, and key global markets.

Plasma fractionation & purification

Hybrid Cohn and chromatographic trains with redundant utilities and validated hold times.

  • Up to 6000L fractionation per batch
  • Nanofiltration and viral inactivation suites
  • Cold-chain warehousing with blockchain traceability

Fill-finish & packaging

Grade A/B isolators with bilingual labelling and country-specific packaging workflows.

  • Vial and IV bag formats (5 mL – 2 L)
  • Serialization aligned with DSCSA & EU FMD
  • Integrated QA oversight with release-by-lot

Tech transfer enablement

Stage-gated methodology covering feasibility, engineering, validation, and commercial ramp.

  • Digital twin modelling and comparability protocols
  • Regulatory submission packages (CTA, BLA, NDS)
  • On-site bilingual training academies

Integrated analytical sciences

In-house laboratories combine compendial testing with advanced characterisation to accelerate release.

Test Turnaround Availability
Protein potency (SRID, nephelometry) 48h On-demand
Viral safety (PCR, NAT, adventitious agents) 72h Weekly campaigns
Impurity profiling (HPLC, mass spectrometry) 96h Project-based
Stability studies & trending Protocol-driven Annual plan

Program blueprints for every stage

Purpose-built packages align with your regulatory roadmap and commercial strategy.

Accelerated feasibility

Four-week sprint to assess plasma stream compatibility, yield, and purity targets.

  • Bench-scale proof in EN/FR deliverables
  • Regulatory gap analysis & roadmap
  • Commercial forecast with Canadian incentives

Launch readiness

Comprehensive support through validation, filing, and market entry.

  • Process validation (IQ/OQ/PQ)
  • Global submission dossier support
  • Lifecycle management & change control

Strategic supply partnerships

Long-term alliances for capacity planning, ESG, and co-development.

  • Dedicated capacity with KPI governance
  • Joint sustainability reporting
  • Integrated partner portal access

Strategic advisory services

Bilingual experts guide regulatory strategy, market access, and supply resilience.

Regulatory dossier authoring (CTA, IND, BLA, NDS) aligned with international requirements.
Market access planning across Canadian provincial formularies and global reimbursement bodies.
Risk and resiliency workshops focusing on dual-language compliance and continuity.

Start a project conversation

Share your scope and our specialists will coordinate a bilingual discovery session within two business days.

Need integrated partner access?

Registered clients can monitor batches, documents, and analytics through the secure partner portal.

Access partner portal