cobra:bio

• Adenovirus (Human ovine & primate)
• Herpes simplex virus
• Adeno-associated virus 
• Lentivirus
• Reovirus

• Cloning (any gene from any source)
• Cell lines: HEK 293, PER.C6, HEK 911, Vero, CSL503 
• Qualified viruses: adenovirus (human & ovine), baculovirus, HSV, lentivirus, & reovirus
• Vector development: plasmid and cell line construction
• Virus rescue
• Characterisation & plaque purification
• Genetic stability testing

• Development of robust and scaleable process strategies
• Media development and optimisation (animal component free)
• Adaptation to suspension-based growth
• Development of close processing systems
• Transfection efficiency optimisation
• Optimisation of harvest parameters to improve both quality and productivity
• Optimisation of multiplicity and point of infection (MOI & POI)
• Development of efficient extraction and primary recovery procedures
• Purification by low pressure chromatography
• Formulation

• Analytical development
• Analytical validation to ICH guidelines
• Cleaning validation
• Stability testing to ICH guidelines
• Raw material testing
• Assay Transfer
• Shipping Studies

Analytical methods include:

(In-house)

• Reverse phase chromatography
• PCR/QPCR
• SDS-PAGE
• Spectrophotometry (UV/visible)
• Fluorimetry
• Western blot
• Pico-green particle assays
• LAL
• Bioburden
• ELISA
• Development of cell based potency assays
• Plaque assays
• TC_ID50
• Restriction enzyme analysis
• Host cell DNA/Protein

(Out-sourced)

• RCA assay

 

• Master Cell Bank & Working Cell Bank production
• Master Viral Seed Stock & Working Viral Seed Stock
• Pre-clinical & clinical supply (BLA batches to be completed in 2009) 
• Validation of commercial processes
• Commercial supply

• 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

• Three Qualified Persons (QP)
• Fully compliant with European Clinical Trials Directive 2001/20/EC and FDA standards
• Authorised by UK MHRA for the GMP of Investigational Medicinal Products (IMPs)
• Support clients with their CMC filings, and will support clients at face-to-face agency meetings
• QP release
• Shipment to clinical trial sites
• Representation at MHRA and FDA meetings to support client programmes
• Process and facility validation advice services
• GXP consultancy for clients

Cobra recognises the importance of trust and transparency between you the client and your dedicated Cobra project manager in every project.

Maintaining clear lines of communication with regular client interaction significantly lessens risk and the chance of time delays.

We believe that a project’s success depends on the delivery of a quality final product from a multi-functional project team on schedule and within budget. Combining our scientific expertise with this project management style is the foundation for building client trust and the reason clients return for future projects.

It is this attitude matched with over 15 years of industry experience that ensures Cobra delivers quality in every aspect of the process, from project conception to product delivery.

Keele
Facility area	ft2	m2
Process development	4,200	390
Class 10,000 clean rooms	2,400	223
Class 100,000 clean rooms	1,500	139
QC	2,000	186
Stores	1,700	158
Plant	5,800	539
Total	24,000	2,583
Oxford
Facility area	ft2	m2
Process development	700	65
Class 1,000 clean rooms	54	10
Class 10,000 clean rooms	1,871	174
Class 100,000 clean rooms	2,469	229
QC	81	8
Stores	1,313	122
Plant	2,368	220
Total	16,000	1,722
Viral Manufacture
Upstream:	24 x 10 Layer Cell Factories
	200 Roller Bottle Capacity (850cm2/1700cm2)
	50L Disposable System (Capacity for larger systems)
	20L, 30L, 100L Working Volume Stirred Tank Bioreactor
	2 x 7L Bioreactors
	150 x T500cm2 T Flasks
	12 x 3L, 25 x 2L Shake Flasks
Downstream:	Modular/Disposable Systems:
	- Manual Chromatography Disposable Flow Path
	- Ultra Filtration/Diafiltration Tangential Flow Filtration Systems
	- Disposable Filtration Systems
	Hardware:
	- BPG Columns (up to 300mm diameter)
	- UV Flow cells (5mm path length)
	- AKTA Purifier / Explorer / Pilot / Process