Our services
Cellular therapies
Cellular therapies and stem cells are exciting and innovative technologies, at the cutting edge of regenerative medicine research and practice. Angel offers development and manufacturing services for cell-based therapeutics, partnering with our clients to develop client-specific, custom protocols to meet each unique need.
The mammalian cell culture team at Angel has extensive experience in cell line selection, cloning, cell banking and cell fermentation process development with xenogeneic, allogeneic and autologous primary human stem cells and other cellular therapies to guarantee the success of your project.
Our development, production and quality departments work closely with our customers to ensure a smooth technical transfer of each process to Angel’s facilities and on to scale-up for cGMP manufacturing. Fermentation and culture processes are developed in our non-GMP cell culture suites, housing wave bioreactors or up to 10L fermenters.
Development services
Angel offers customer support in the following:
- developing bespoke processes according to customer needs including pre-GMP regulatory support (e.g. adaption to serum-free conditions);
- development of product-specific assays (viability, characterisation and potency);
- release assay pre-validation studies;
- stability testing (both cell bank and final product);
- shipping options to support delivery systems; and
- test article preparation for biosafety testing house.
Our areas of expertise include:
- cell line selection;
- cloning;
- cell fermentation;
- primary cell line establishment from tissue and blood (micro-dissection, enzymatic and mechanical);
- maintenance of wide variety of cells (differentiated, progenitor and stem cell); and
- process scale-up (multi-layered flasks, roller bottles, mammalian bioreators and wave bag systems).
Once a process has been demonstrated to be fully reproducible it is transferred from development to larger-scale cGMP manufacture. This helps maintain flexibility during the development process and offers the opportunity to optimise the process by (i) reviewing cost of goods and (ii) reducing time required within the cGMP facility for production.
cGMP manufacturing
Our areas of expertise include:
- stem cell isolation, purification and derivation from autologous and allogeneic sources;
- development of ex vivo stem cell expansion processes including differentiation and production to ensure that large numbers of homogenous cells are produced under reproducible conditions;
- classification of protein expression by immunocytochemistry to determine purity, phenotype and potency of cells in culture;
- sourcing and auditing of reliable contractors for more detailed phenotypic classification of cells, such as qPCR gene expression studies;
- cell viability assays for final product shelf-life studies;
- production of suspension or adherent master cell banks (MCB), working cell banks (WCB) and research cell banks (RCB) using multi-layered flasks, roller bottles, mammalian bioreactors and wave bag production;
- control rate freezing;
- isolation of target active compounds from bioreactor product, such as monoclonal antibodies;
- In-house biosafety testing (mycoplasma, endotoxin, etc.);
- Shipping validation studies, including both product viability and container closure; and
- Parametric release testing.
Cell/viral/phage bank storage
The facility accommodates two vapor phase liquid freezers dedicated to the segregated storage of cell banks. Bacterial and phage banks are stored in -80°C freezers with a backup liquid nitrogen system. Freezers are annually mapped and validated and continually monitored by the AV100 monitoring system. A planar controlled rate freezer model 560-16 is available for optimising temperature freezing profiles.
Final product
To expedite your move to the clinic, Angel provides bespoke fill and validated shipping solutions that are complementary to the clinical delivery system for the final product. Final product can be aseptically dispensed into appropriate containers, supported by appropriate final product testing data. Angel has experience in parametric release testing for products with a limited shelf life, supported by the utilisation of rapid quality control testing procedures.
Areas of expertise
Learn more
Our facilities
Angel's MHRA licensed facilities are located at Pentlands Science Park on the outskirts of Edinburgh.
