cobra:bio

• 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)

• 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 recover procedures including inclusion body purification
• Formulation development
• Sterile harvest & cell washing facilities

• 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)

• Identity by microbiological characterisation of the strain
• Purity (monosepsis)
• Strength by determination of viability
• Western blot
• LAL
• Activity/infectivity assays

• Master Cell Bank & Working Cell Bank
• Phase I , II & III bulk API

• 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

• Two in-house Qualified Persons (QP)
• Fully compliant with European Clinical Trials Directive 2001/20/EC
• 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 of final products to clinical sites
• Shipping 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
	Capacity
Fermentation development	4x 7L Microbial, 2x7L Mammalian, 20L Wave bag
cGMP manufacture	2x 100 roller bottles
	1x 20L, 1 x 50L, 1 x 200L stirred tank, 50L Wave bag
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
	Capacity
Fermentation development	2x 7L, 1 x 20L stirred tank
cGMP manufacture	1x 20L, 2x 30L, 1x 100L stirred tank/perfusion
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