Our Expertise
From host and vector strategy to manufacturing readiness
An integrated approach to cell line development, cell culture media development and upstream process development – linking cell biology, media, process conditions and scale-up to robust, manufacturable biologics processes.
Cell Line Development
Host, vector and selection-system strategy, clone screening and selection, stability and clonality – planned for the molecule and its CMC path.
Cell Culture Media Development
Media and feed optimisation, raw-material strategy and metabolic interpretation to lift growth, titre and consistency.
Upstream Process Development
Shake-flask and bioreactor development, fed-batch and perfusion, seeding and feeding strategies and process intensification.
Process Characterisation & Optimisation
QbD, DoE, critical process parameters, robustness and qualified scale-down models.
Scale-Up & Technology Transfer
Transfer strategy, CMC and process-transfer packages, site gap analysis, comparability and receiving-site readiness.
CMC & Development Strategy
CMC planning, IND/BLA documentation support, technical due diligence and investment readiness.
AI/ML & Bioprocess Data Analytics
Machine learning, multivariate analysis, PAT/Raman and predictive modelling to design smarter experiments.
Development Capability Building
Laboratory set-up, workflows, SOPs, qualification, biosafety/GMO compliance and technical team mentoring.
How clients typically work with Z2
CLD Strategy / Programme Review
Host/vector strategy, screening, clone selection, stability, troubleshooting and independent CLD programme review.
Learn MoreUpstream Development & Optimisation
Media/feed optimisation, bioreactor development, scale-up/down, robustness and upstream CMC process understanding.
Learn MoreTechnology Transfer
CLD/upstream knowledge transfer, comparability, gap assessment and receiving-site/CDMO readiness.
Learn MoreDue Diligence & CMC Regulatory Review
Independent technical assessment, CMC risk review and scientific support for IND/BLA and regulatory documentation.
Learn MoreLaboratory & Capability Establishment
CLD/bioprocess laboratory set-up, equipment, workflows, qualification, SOPs and operational readiness.
Learn MoreBiosafety, GMO & Compliance Readiness
Risk assessments, GMO/containment, COSHH/BioCOSHH, H&S and associated compliance documentation.
Learn MoreInvestment & Fundraising Support
Scientific support for grants, funding and investor materials, including technical due diligence and investment-readiness assessment.
Learn MoreTraining & Team Development
Industry-relevant training in cell culture, upstream PD, DoE/QbD, scale-up and AI/ML for bioprocess scientists.
Learn MoreYour questions, answered
Z2's focus is monoclonal antibodies and recombinant proteins, including complex formats such as bispecifics and fusion proteins. Experience also extends to mRNA therapeutics and emerging biotechnology platforms.
Z2 is a scientific consultancy. We design, review and troubleshoot programmes, build development strategies and capability, and support your team, CDMO or partner laboratory in executing the work.
Z2's direct focus is cell line and upstream development. Where a programme needs wider input, Z2 draws on a panel of experienced consultants covering downstream processing, analytical/bioanalytical and manufacturing interfaces.
Engagements range from a focused programme review or due-diligence assessment to ongoing development support. We agree the scope, deliverables and timelines with you at the start.
Let's talk about your programme
Whether you are designing a CLD programme, stuck on an upstream process, preparing for technology transfer, or assessing a biologics asset before you commit.
Call Anil