ATMP process technologies
Our experts can help you through every step of your journey to develop your ATMP. Working together, we can identify and overcome product development barriers, helping you create customised, integrated solutions to rapidly progress your cell and gene therapies. Our experienced teams employ innovative approaches to make your ATMP processes more cost-efficient, scalable, safe, and robust. With our quality by design (QbD) expertise, these can be seamlessly transferred to any GMP facility.
With our quality by design (QbD) expertise, our experienced teams can suggest innovative ways to make your ATMP processes more cost-efficient, scalable, safe, and robust.
Viral vectors
Together, we can generate innovative bioprocessing and characterisation solutions for the development, analysis and production of viral vectors.
We have worked with experts in the field to develop a platform for the large scale manufacturing of Adeno Associated Virus (AAV) to benefit your therapy manufacturing.
Benefit from our expertise in:
Viral vector bioprocessing and characterisation solutions
Increased efficiency and quality of your viral vectors production processes.
Establishing your manufacturing process in GMP manufacturing facilities.
Production of high-yield and high-purity viral vector batches (AAV and Lentivirus)
Providing clinical grade product for therapy development.
Viral vector upstream, downstream, and analytical methods
Establish GMP compliant AAV characterisation and purity testing for adherent or suspension-based formats.
Solution-focused capabilities
When collaborating with us you can call upon a multi-disciplinary team of experts, including specialists in:
Production of viral vectors
Virologists, cell engineers, upstream bioprocess engineers (with a focus on adherent and suspension-based systems), GMP specialists, and omics experts.
Purification of viral vectors
Physical and analytical chemists, biochemists, and downstream bioprocess engineers.
Product and impurity characterisation
Molecular biologists, cell biologists, applied spectroscopists, data scientists, and biostatisticians.
Stem cell expansion and differentiation
A robust scale-up strategy for stem cell manufacture is an important step in the journey towards market-ready stem cell products.
Our scientists have developed robust, scalable manufacturing processes for pluripotent stem cell production (PSC) including knowledge of high-throughput and high-content metabolomics, secretomics and transcriptomics analyses, to enable your PSC development.
Benefit from our expertise in PSC production processes, analytics and product characterisation:
Drivers of lineage bias
Identify and optimise induced pluripotent cells (iPS) cell differentiation.
Data analytics
Multivariate data analyses of biomarker datasets to provide you with the optimal pathway.
iPSC-derived therapy manufacturing process analysis
Develop solutions and mitigations to ensure GMP compliant processes and products.
Closed and controlled upstream and downstream processing
Greater control of PSC processes, including the use of our proprietary confluency algorithm.
Starting material characterisation
Develop and optimise assays, e.g., flow cytometry, gene expression arrays and karyotyping to define the quality of your starting material.
High content analytics for process and product characterisation
Tandem flow cytometry and gene expression panels to optimise PSC expansion and differentiation process development.
Process Analytical Technology (PAT)
Integrated in-line PAT e.g., RAMAN technology for optimal control of your PSC processes.
Non-destructive assays for proteomics and metabolomics
Effective monitoring and control of expansion and differentiation, e.g., spent media analysis.
Cell engineering platform for technology assessment and ATMPs development
Our Cell Engineering Programme generates an end-to-end scalable, non-viral cell engineering platform for allogeneic immunotherapies focusing on four key areas: gene delivery, gene editing, bioprocessing and analytics.
We can help you find the right innovative cell engineering technology to speed up the development of your ATMPs.
Benefit from our expertise in:
Gene Delivery
Understand how to use innovative technologies such as nanoparticles, mechanical, biochemical and physical methods.
Gene Editing
Application of novel tools for gene editing that enable safer and more cost-efficient allogeneic immunotherapies.
Bioprocessing
Translate gene-engineered ATMPs from small-scale proof-of-concept studies to larger scale clinical stage processes.
Analytics
Refined molecular and functional characterisation of engineered cells using a range of analytical methods, including ddPCR, flow cytometry, cytokine panels.
Bioprocess control and automation
Adequate control of bioprocesses is essential for the safe and effective manufacture of advanced therapies. The complexity of ATMP manufacture demands a QbD approach, where production processes are devised using a risk-based framework. It is vital to assess the Critical Process Parameters (CPP) of products during their manufacturing process to guarantee the final ATMPs will be safe, efficacious and meet GMP standards.
Our team of QbD and automation experts can adapt your processes so that product quality is monitored in real time, with datasets collected and analysed appropriately, to predicted and prevent quality issues. Our centralised adaptive control platform can be applied for stem cells or viral vector process automation.
Benefit from our expertise in:
Device integration
Inter-connectivity between production control devices through customised integration of equipment, giving enhanced process control.
Data handling and transfer
Employing the latest data capture and transfer protocols.
Process Analytical Technologies (PAT)
Monitor and adjust your manufacturing process real-time to ensure optimal final product yield and quality.
Semi-automated assays
Reduced assay variability and human error through user-friendly interfaces and automated processes such as qPCR.
Data evaluation and standardisation
Standardised data capture and processes, for compliant use in GMP production.
Digital, data and analytics
Application of new technologies, software and data-processing solutions can transform ATMP manufacture processes. Our data scientists, biostatisticians and Process Analytical Technology (PAT) experts can ensure you use these tools effectively, maximising data integrity, analysis and interpretation of results.
Benefit from our expertise in:
Data integrity
Improved maintenance and traceability of raw and processed data.
Data analytics
Pathway and multivariate data analyses of your large omics and biomarker datasets.
Biostatistics
Benefit from interpretation of quantitative analyses through our knowledge of experimental design, data quality, and method validation.
Modelling and simulations
Constructing mechanistic models, chemometric and machine learning algorithms and simulations for rapid process understanding and development.
Cloud based computing
Hosting process/analytical databases, enable computationally expensive calculations and facilitate trend analysis and data mining.
Process Analytical Technologies (PAT) (Raman spectroscopy, metabolomics and proteomics)
Advanced product characterisation, process understanding and real-time adaptive control strategies for ATMP manufacture at scale.
Bespoke app-based applications
Automated data analysis and reporting through bespoke use of applications as RT-qPCR genomic viral titre analysis, cell confluence analysis and environmental monitoring.
GMP translation
Transferring an ATMP process from the laboratory to a GMP facility presents unique challenges relating to variability in processes using human cells or viral vectors.
With our extensive experience we can ensure you develop processes appropriate for pharmaceutical quality systems, optimised set-up, automation, and risk management strategies necessary to meet GMP standards.
Our GMP-like laboratories are ideal for testing of processes and their set up prior to transitioning to a full GMP environment for clinical production.
Benefit from our expertise in:
Process evaluation
Reduce your timelines for the establishment of GMP manufacture of ATMPs by using paper-based analysis and assessment of your development process.
Closed and contained processes
Use our extensive knowledge of GMP ATMP processes to optimise where and how to close your processes, reducing the risk of contamination to enhance product quality and regulatory compliance.
Materials optimisation
We can help you plan your materials movement and scheduling to enhance productivity
Working on a cell or gene therapy innovation challenge?
Contact us today to find out how we can support you.