cobra:bio

Cells

Providing a full range of services from
gene cloning to cGMP manufacture for
pivotal pre-clinical to clinical trials,
Cobra delivers results to the highest
standards of excellence.

Hosts

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)

Process Development & Scale Up

Development of fully closed, sterile processes for whole cell products

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

Formulation

Sterile harvest & cell washing facilities

Analytical Development & Qualification

Analytical method transfer, development, qualification & validation

Analytical methods include: Identity by microbiological characterisation of the strain, purity (monosepsis), strength by determination of viability, development of cell based potency assays

cGMP Manufacturing

Master Cell Bank & Working Cell Bank production

Pre-clinical and clinical supply

Fill / Finish

Audited filling houses

Project managed

Detailed timeline planning & milestone tracking

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

Two Qualified Persons (QP)

Fully compliant with European Clinical trials Directive 2001/20/EC and FDA standards

Authorised by UK MHRA for the GMP production of Investigational Medicinal Products (IMPs)

Support customers with their CMC filings

Representation at MHRA and FDA meetings

QP release

Shipment to clinical trial sites

Project Management

Dedicated Project Manager

Cross-functional project teams

Detailed timeline planning and milestone tracking

Program managed by single point of contact

Regular process updates

Risk management

Live Cell Services (52K) PDF

"We look forward to continuing our relationship with Cobra as we move forward with the development of live vaccines for the treatment of cancer. Our initial clinical work demonstrated the real world utility of our concepts, and Cobra's ability to execute their production as potential cancer immunotherapeutic agents."

John Rothman
Vice President
Clinical Development

Cobra changed its name from Therexys to Cobra Therapeutics in 1998

News Alert

View privacy policy