cobra:bio

DNA

Cobra Biologics is a leading international cGMP manufacturer of plasmid DNA for preclinical and clinical supply. Our success comes from the experience and expertise gained as a solution provider.

Molecular Biology

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

Process Development & Scale Up

Fermentation & media development

Evaluation of productivity and optimisation of harvest point

Lysis optimisation (primary recovery)

Non-animal derived components

Production for pre-clinical efficacy testing and pivotal preclinical safety testing

Formulation

Analytical Development & Qualification

Assay transfer

Product characterization

QC release testing

QC testing of Drug Substance & Drug Product

Stability studies: Drug Substance and Drug Product

To ICH guidelines
Forced degradation studies

Cleaning validation

Raw material testing

Shipping studies

cGMP Manufacturing

Master Cell Bank & Working Cell Bank production

Pre-clinical & clinical supply

Fill / Finish

Aceptic production

Syringes and vials

Freeze-drying / lyophilisation

Clinical 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

Two Qualified Persons (QP)

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

Authorised by UK MHRA for the cGMP 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

Milestone tracking

Program managed by single point of contact

Regular process updates & risk management

DNA Services (370K) PDF

First client product Cobra manufactured was DNA in 1998

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