Cell Therapies brings domain expertise across a wide range of manufacturing and analytical modalities to add tangible value at every step of your development lifecycle. Our process development services are customized to your product’s unique attributes and clinical strategy — from rapid prototyping and optimization to validation and transfer into GMP suites.
Developing Your Purpose-built Manufacturing Process
We Understand Cell-based Drug Products
Core Development Stages
Excellence from the beginning
Cell Therapies offers strategic guidance to research teams, spinouts, and biotech innovators during preclinical development. Our experts provide consultation on:
- Cell processing workflows for scalability and compliance
- Raw material selection aligned with GMP readiness
- Analytical development plans that anticipate regulatory expectations
- Clinical & regulatory timelines, including CTN/CTA strategy in APAC
- Collaborative funding initiatives, including partnerships with academic research teams, MRFF programs, and translational grant schemes
This early engagement ensures a smoother path to IND-enabling studies and de-risks future tech transfer into GMP.
Phase-appropriate development
Cell Therapies specializes in translating benchtop protocols into reliable, scalable processes ready for first-in-human trials. Our team combines deep technical knowledge with an understanding of regulatory expectations to:
- Maintain fidelity to the Target Product Profile (TPP)
- Define and optimize critical process parameters (CPPs)
- Implement closed system technologies (e.g., Prodigy®, Cocoon®, Octane)
- Accelerate tech transfer and DoE-driven optimization
- Support IND/CTA readiness with process and analytical documentation
Cell types supported include:
- CAR-T and TCR-T lymphocytes (autologous and allogeneic)
- Natural killer (NK) cells and invariant NK-T cells
- Mesenchymal stromal cells (MSCs)
- iPSC-derived lineages (immune, epithelial, neuronal)
- Exosomes and extracellular vesicles
Robust and efficient GMP manufacturing
For programs approaching pivotal trials or commercial launch, Cell Therapies offers expertise in cost-optimization, throughput expansion, and regulatory robustness.
Key capabilities include:
- COGS modeling and reduction strategies
- Process standardization and lock using statistical tools and PAT
- GMP process validation (URS ➜ PQ) and comparability studies
- Automated & digital manufacturing execution (Apprentice eBR, MasterControl EQMS)
- Scalable suite access with seamless transition from development to GMP in the same facility
- Phase-appropriate QMS and documentation alignment to support global filing (TGA, PMDA, FDA, EMA)
Our hybrid approach, combining research agility with commercial QA rigor, allows sponsors to scale confidently from Phase 1 to global market access.
Process Development
From Concept To Commercialisation
With over two decades of experience in GMP manufacturing of cell-based products, Cell Therapies is a trusted partner in transforming promising research into scalable, compliant, and commercially viable therapies.
Our process development offering bridges discovery and manufacturing with a clear focus on translational excellence, leveraging closed systems, automation, and advanced analytics to accelerate time-to-clinic while ensuring long-term manufacturability. Whether you’re at the start of a first-in-human trial or optimizing for global commercial launch, our expert team and purpose-built facilities support your success.
Our dedicated Development Laboratory offers clients early access to established and emerging platforms, enabling the design of robust, phase-appropriate manufacturing processes grounded in real-world GMP requirements.
Capabilities Snapshot
Experts In Scaling And GMP-readiness
- Closed‑System Prototyping (CliniMACS Prodigy®, Cocoon®, Lonza Octane)
- Scale‑Up & Scale‑Out Modelling using digital twins
- In‑Process Analytics – on‑line flow cytometry, dielectric spectroscopy
- DoE & Multivariate Analysis to lock Critical Process Parameters
- Tech Feasibility-to-PPQ track in a single facility, cutting tech‑transfer risks
Why Cell Therapies for Process Development?
De-risk Your Program And Drive Timelines
- Integrated Development & Manufacturing Site – No inter-facility tech transfer
- Rapid Prototyping with GMP in Mind – Avoids costly rework at later stages
- APAC-Focused, Globally Aligned – Tap into regulatory and manufacturing pathways in Asia-Pacific with Cell Therapies as your lead partner
- Digital-First Execution – Real-time batch visibility, audit-ready compliance
- Track Record – Supported over 20 cell-based products from concept to clinic
cell therapies is an Australian-based, globally-active commercial contract development and manufacturing company, specializing in cell therapy, gene therapy, regenerative medicine, and cellular immunotherapy products
Services
Helpful Links
Corporate
Victorian Comprehensive Cancer Centre
Level 9, 305 Grattan Street,
Melbourne, VIC,3000
Australia
+61 3 9492 4777
[email protected]
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