Project Management
Dedicated Project Manager
Multi-functional project teams
Detailed timeline planning and milestone tracking
Program managed by single point of contact
Regular process update through telecom or face-to-face meetings
Risk management
Cell Line Development
Molecular biology
Cloning (any gene from any source)
Expression vector development
Proprietary technology:
- Rapid mammalian protein production, UCOE
- Antibiotic-free Plasmid Maintenance System: ORT®
Stability testing
Vector development: free to use and proprietary systems
Cell lines: CSL 503, HEK 293, PER.C6, HEK 911, Vero, Sf9 & Hi5, CHO, CHO-S
Qualified viruses: adenovirus (human & ovine), baculovirus, HSV, lentivirus & reovirus
Vector development: plasmid and cell line construction (insect & mammalian host cells)
Virus rescue
Characterisation & plaque purification
Genetic stability testing
Strain Development
Cloning (any gene from any source)
Cytoplasmic accumulation and periplasmic secretion systems
E.coli Expression System:
- antibiotic free maintenance technology (ORT®)
- Bacteriophage-free T7 expression system
Qualified E.coli strains (examples):
Plasmid stability testing
Expression plasmid and host strain development
E.coli expression systems:
- Ptrc
- ParaBAD
- Lambda PL/PR
- T7
Bacteria
Listeria monocytogenes (recombinant, attenuated)
Serratia marcescens (non-recombinant, heat-killed at end of process)
Streptococcus pyogenes (non-recombinant, heat-killed at end of process)
Salmonella Typhimurium (recombinant attenuated)
Virus Products
Adenovirus
Baculovirus
Herpes simplex virus
|
Lentivirus
Reovirus |
Production Systems
CHO
NSO
GS-CHO hybridomas
Myelomas
|
E.coli
Bacillus subtilis
PER.C6 |
Process Development & Scale Up
Development of robust and scaleable manufacturing processes
Media development and optimisation (animal component free)
Optimisation of harvest parameters to improve both quality and productivity
Development of efficient extraction and primary recovery procedures (including inclusion body purification)
Chromatographic purification
Purification by low pressure chromatography
Formulation development
Fermentation & media development
Evaluation of productivity and optimisation of harvest point
Lysis optimisation (primary recovery)
Non-animal derived components
Proprietary technology:
- DNA process (Type II Drug Master File (DMF) with US FDA)
Production for pre-clinical efficacy testing and pivotal preclinical safety testing
Optimisation of multiplicity and point of infection (MOI & POI)
Sterile harvest & cell washing facilities
Analytical Development & Qualification
Assay transfer
Analytical development
Analytical validation to ICH guidelines
Product Characterization
Protein characterization for IND submissions
Analytical reference standards
QC Release Testing
- QC testing: Drug Substance and Drug Product
Cell based potency assays
Stability Studies: Drug Substance & Drug Product
- To ICH guidelines
- Forced degradation studies
- Pre-formulation studies
- Cleaning validation
Raw material testing
Shipping studies
cGMP Manufacturing
Master Cell Bank & Working Cell Bank
Master Viral Seed Stock & Working Viral Seed Stock
Production in stirred tank bioreactors/fermenters,SUBs, Wave bags, roller bottles, spinner flasks, shake flasks & cell factories
Phase I, II & III clinical to commercial scale supply
Fill / Finish
Aseptic production
Syringes and vials
Freeze-drying / lyophilisation
Clinical to commercial scale supply
Primary/Secondary Labelling
Primary labelling (or re-labelling) of drug product vials for human clinical centres
Secondary packaging and labelling of vials for dispatch to clinical centres
Tertiary and transport labelling & packaging as required
Guidance on regulatory requirements and details of primary and secondary labels
Fully traceable clinical labelling to batch records, under QA observation with QP review and issue of cGMP Certificate of Compliance.
Phase I and Phase II labelling supporting clinical trials worldwide
Regulatory documents review as required to support release to clinic
Quality Assurance & Regulatory Support
Three Qualified Persons (QP)
Fully compliant with European Clinical trials Directive 2001/20/EC and FDA standards
Licensed for cGMP manufacture in Sweden and the UK
Support customers with their CMC filings
Representation at MHRA and FDA meetings
QP release & shipment to clinical trial sites