Mammalian Cell Bioprocessing · FlexBIO at Heriot-Watt University
From vial thaw to pilot-scale harvest - without building your own facility.
FlexBIO's dedicated mammalian Containment Level 2 suite supports CHO, HEK293, and other cell lines from 2L to 15L with integrated downstream processing and analytical services for the data your investors and regulators expect.
🧫 CHO · HEK293 · Stem Cells and other lines
⚗️2L · 15L mammalian bioreactors
🔒Dedicated CL2 mammalian suite
📍Heriot-Watt University, Edinburgh
Development pathway →
Vial Thaw & Recovery → Cell Expansion (shake flask) → 2L Bioreactor Development → 15L Scale-Up Confirmation → Harvest & Clarification → Purification DSP → Analytics & Data Package
Everything you need for
mammalian cell scale-up
This page brings together all FlexBIO services and resources relevant to mammalian cell process development. Navigate directly to the area most relevant to your project.
Core service
Upstream Cell Culture & Bioreactor Scale-Up
Fed-batch, batch, and perfusion culture in our dedicated mammalian CL2 suite. We develop and optimise culture media, feeding strategies, and process conditions from 2L development scale through to 15L pilot confirmation runs.
Fed-batch | Perfusion | Continuous | CL2 certified
Cell lines
Supported Cell Lines & Expression Systems
CHO, HEK293, stem cells, and other mammalian lines. Recombinant protein, monoclonal antibody, viral vector, and gene therapy applications.
CHO | HEK293 | Stem cells
Downstream processing
Harvest, Purification & DSP Development
From harvest centrifugation through tangential flow filtration, depth filtration, and chromatographic purification — integrated DSP workflows co-developed alongside your upstream process.
TFF | Chromatography | Depth filtration
Analytics
Process Analytics & Product Characterisation
Real-time monitoring of cell density, viability, metabolites, dissolved oxygen, and product titre. Data delivered in CMC-ready formats for regulatory and investor submissions.
Viability | Metabolite profiling | CMC data
How to engage
Access Models — Direct Use, Service & Contract
Three ways to work with FlexBIO — from supervised direct-use access for experienced teams, to fully managed research services for milestone-driven development programmes.
Direct-use | Managed service | Research contract
Get started
Free Technical Consultation
Every engagement begins with a no-obligation technical conversation. Describe your cell line, process stage, and goals — we'll advise on the right approach and provide a project proposal within 5 working days.
Free consultation | 5-day turnaround
Upstream Bioprocessing
Mammalian cell culture & bioreactor scale-up
FlexBIO operates a physically separated mammalian CL2 suite to eliminate cross-contamination risk between microbial and mammalian workstreams. Our bioprocess engineers have hands-on experience developing fed-batch, batch, and perfusion processes for recombinant protein, monoclonal antibody, and viral vector applications.
We work alongside your team from the outset — adapting your existing process or building one from first principles — and provide structured data packages at each milestone to support fundraising, partnership discussions, or regulatory submissions.
2L Bioreactor Development
Initial process characterisation at development scale. Culture media screening, inoculation density optimisation, and process parameter mapping (pH, DO, temperature, agitation).
15L Scale-Up Confirmation
Pilot-scale demonstration runs to confirm scalability of conditions identified at 2L. Mixing time, oxygen transfer rate (kLa), and shear sensitivity assessments included.
Fed-Batch Culture Optimisation
Development and refinement of feeding strategies to maximise viable cell density and product titre. Nutrient profiling and metabolite monitoring integrated throughout.
Perfusion & Continuous Culture
For processes requiring sustained culture with continuous product removal. Our team has experience in hollow-fibre perfusion and alternating tangential flow (ATF) set-up at pilot scale.
Containment Level 2 — Mammalian Suite
Dedicated CL2-certified mammalian workspace, physically separated from the microbial suite. Supports wildtype and recombinant cell lines under full biosafety protocols.
Supported Expression Systems
Cell lines we work with
FlexBIO supports a broad range of mammalian host cell systems. If your cell line is not listed below, contact us — our team's experience extends across a wide range of production hosts and we can advise on suitability before any commitment.
| Cell line | Primary applications | Notes | Status |
|---|---|---|---|
| CHO (Chinese Hamster Ovary) | Monoclonal antibodies, recombinant proteins, biopharmaceuticals | Industry-standard mammalian expression system; extensive FlexBIO experience with CHO-K1 and CHO-S variants | Available |
| HEK293 | Viral vectors (AAV, lentivirus), transient transfection, gene therapy products | Suitable for both stable and transient expression. Frequently used in gene therapy and advanced therapy medicinal products (ATMPs) | Available |
| Stem Cells | Regenerative medicine, cell therapy, disease modelling | Experience with mesenchymal stem cells (MSCs) and induced pluripotent stem cells (iPSCs); process conditions tailored to maintain potency | Available |
| Vero | Viral vaccine production, virus propagation | Adherent and suspension-adapted variants. Microcarrier-based scale-up experience available on request | Available |
| NS0 / Sp2/0 | Monoclonal antibody production | Murine myeloma lines for antibody manufacturing applications | Available |
| Suitable for | Inoculum prep, validation batches, short TRL studies | Production runs, high-titre protein expression, scale-up demonstration | Available |
| Other mammalian lines | Project-specific applications | Our team's experience extends beyond this list — contact us to discuss your specific host and product combination | Enquire |
Downstream Processing
Harvest, purification & product recovery
Effective downstream processing is co-designed alongside the upstream campaign from the outset at FlexBIO — not bolted on as an afterthought. Our DSP team has extensive experience with mammalian cell harvests and the clarification, filtration, and purification unit operations required for biopharmaceutical and advanced therapy products.
For in-house runs up to 15L, we provide an integrated end-to-end service. For clients with larger external streams, our DSP capabilities extend to 1kL IBC intake.
Harvest & Clarification
Batch and continuous centrifugation for mammalian cell removal. Depth filtration for clarification of culture supernatants prior to further processing.
Tangential Flow Filtration (TFF)
Ultrafiltration and diafiltration for product concentration and buffer exchange. Scalable TFF systems available at lab and pilot scale.
Chromatographic Purification
Protein A affinity, ion exchange, size exclusion, and hydrophobic interaction chromatography using the ÄKTA Avant 150 automated purification system.
Final Form & Formulation
Freeze-drying (lyophilisation) and spray drying for product preservation and final form development. Bulk fill and labelling available for demonstration batches.
Integrated DSP Strategy & Reporting
Structured DSP development reports aligned to CMC requirements. Mass balance, yield accounting, and step-recovery data included as standard for all research services contracts.
Process Analytics
The data your process
needs to progress
Comprehensive process analytics underpin every mammalian cell campaign at FlexBIO. Without data, you're guessing. We integrate online and offline analytical tools throughout every project, so you carry forward a detailed mechanistic understanding of your process into the next scale.
Real-time monitoring
Online Process Analytics
Continuous measurement of dissolved oxygen (DO), pH, temperature, CO₂ offgas, and optical density. Biomass probes and capacitance sensors available for live cell density tracking without sampling.
Product quantification
Titre Monitoring & Product Analytics
Protein A HPLC, ELISA, and SDS-PAGE for product titre quantification and purity assessment. Supports productivity tracking throughout the culture run and into DSP.
Cell health
Viability & Cell Count
Routine viable cell density (VCD) and cell viability assessment throughout the culture run. Trypan blue exclusion and automated cell counting available. Morphology monitoring on request.
Data delivery
CMC-Ready Data Packages
All analytical data delivered in agreed formats for inclusion in technical reports, regulatory dossiers (IND, IMPD), or investor data rooms. Milestone-structured reporting available for longer development programmes.
Metabolite profiling
Nutrient & Metabolite Analysis
Offline profiling of glucose, lactate, glutamine, glutamate, ammonia, and other key metabolites. Enables rational feeding strategy development and culture condition optimisation.
Characterisation
Process Understanding & DoE
Design of Experiments (DoE) approaches available for systematic process characterisation. Identification of critical process parameters (CPPs) and critical quality attributes (CQAs) for regulatory alignment.
How to work with us
Three ways to access
FlexBIO's mammalian capabilities
Choose the engagement model that fits your organisation's expertise level, timeline, and project scope. All models include IP protection and full confidentiality as standard.
Direct-Use Access
Your team works in our mammalian suite using our equipment, with FlexBIO technical staff on-site for supervision and support. Best for organisations with existing cell culture expertise who need pilot-scale infrastructure they don't own.
Best for: teams with in-house bioprocess expertise · Short-term equipment needs · Cost-sensitive programmes with SME discounts available
Short-Duration Service
Our bioprocess engineers operate the mammalian suite on your behalf for a defined, bounded scope of work over one to several days. Ideal for organisations without dedicated cell culture resource, or those needing rapid turnaround scale-up data.
Best for: biotech startups needing scale-up data for fundraising · Academic groups without pilot-scale equipment · Defined, single-stage experiments
Research Services Contract
A structured multi-stage engagement with defined work packages, milestone sign-off, and comprehensive technical reporting. Suitable for longer development programmes, CMC data generation, and regulatory-adjacent projects including ATMPs and gene therapy applications.
Best for: CMC development · IND/IMPD data generation · ATMP development · Longer-term scale-up partnerships
Ready to discuss your
mammalian cell process?
Every project starts with a free, confidential technical consultation. Bring us your process data and your goals — we'll tell you what's achievable and what the path looks like.
📧 scaleup@ibioic.com · Response within 2 working days · SME discounts available