cobra:bio

• Cloning (any gene from any source)
• Proprietary technology:
  • Antibiotic free maintenance technology (ORT^®)
• Qualified strains (examples):
  • DH1
  • DH1-ORT
  • DH5α
• Plasmid stability testing
• Vector development: plasmid and strain construction
• Sequencing

• 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
• 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)

• spectrometry (UV)
• restriction enzyme analysis
• free solution capillary electrophoresis
• RNA analysis by RP-HPLC & Syber Green
• host protein analysis by ELISA
• host DNA analysis by PCR/QPCR
• Agarose gel electrophoresis
• residual solvents by GC
• LAL
• Bioburden

(Out-sourced)

• DNA sequencing

 

• Master Cell Bank & Working Cell Bank production
• Pre-clinical & clinical 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
DNA Manufacture
Upstream:	1L Shake Flasks
	5L Stirred Bioreactor
	50L Stirred Tank Bioreactor
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