cobra:bio

Protein

Cobra Biologics offers a broad range of integrated and stand-alone development and cGMP services for mammalian and microbial derived therapeutic proteins, monoclonal antibodies and FABs preclinical through to Phase III clinical supply.

Experience

CHO

CHO-S

Hybridomas

Myelomas

PER.C6

Cell Line Development

Molecular biology:

Cloning (any gene from any source)
Expression vector development

maxXpress Service:

Rapid mammalian protein production, UCOE

Qualified strains:

CHO
CHO-S
Hybridomas
Myelomas
PER.C6

Stability testing to ICH guidelines

Vector development: free to use and proprietary systems

Process Development & Scale Up

Development of robust and scaleable 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

Chromatographic purification

Formulation

Analytical Development & Validation

Assay transfer

Product Characterization

Protein characterization for IND submissions

Analytical reference standards

QC Release Testing

QC testing: Drug Substance and Drug Product

Cell based potency assays

Stability Studies: Drug Substance & Drug Product

To ICH guidelines
Forced degradation studies
Pre-formulation studies

cGMP Manufacturing

Master Cell Bank & Working Cell Bank production

Cell bank characterisation

Clinical to commercial scale supply

Fill / Finish

Aceptic production

Syringes and vials

Freeze-drying / lyophilisation

Clinical to commercial 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

Licensed for cGMP manufacture in Sweden and the UK

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

Cobra Biologics has carried out over 20 IgG pre-clinical supplies

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