Viruses

DNA protein


An experienced manufacturer of cGMP virus products for gene therapies and vaccines. Our goal is to deliver our customers' virus programs in a cost effective and timely manner.
cells

We have made over 40 virus batches


Products

Adenovirus (Human ovine & primate)

Herpes simplex virus

Adeno-associated virus 

Lentivirus

Reovirus

Cell Line & Virus Vector Development

Cloning (any gene from any source)

Cell lines: HEK 293, PER.C6, HEK 911, Vero, CSL503, A549

Vector development: plasmid and cell line construction

Virus rescue

Characterisation & plaque purification

Genetic stability testing

Process Development & Scale Up

Development of robust and scaleable process strategies

Media development and optimisation (animal component free)

Adaptation to suspension-based growth

Development of close processing systems

Transfection efficiency optimisation

Optimisation of harvest parameters to improve both quality and productivity

Optimisation of multiplicity and point of infection (MOI & POI)

Development of efficient extraction and primary recovery procedures

Purification by low pressure chromatography

Formulation

Analytical Development & Qualification

Analytical method transfer, development, qualification & validation:
 
Reverse phase chromatography,Ion exchange chromatography, PCR, SDS-PAGE, ELISA, LAL, Bioburden, Spectrophotometry (UV/visible), Fluorimetry, Capillary electrophoresis; Mass spectrometry, Picogreen particle assays, Electron microscopy, Plaque assays, TCID50 assays

Development of cell based potency assays

Fill / Finish

Audited filling houses

Project managed

Detailed timeline planning

Milestone tracking

cGMP Manufacturing

Master Cell Bank and Working Cell Bank production

Master Viral Seed Stock and Working Viral Seed Stock production

Clinical manufacture, including disposable systems

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 clients 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

Over 30 GMP batches have been produced for clinical trials 

Cobra was one of the first CMOs to produce Adenovirus

   
 

 

News Alert

View privacy policy

Copyright © 2012 cobra biologics. All rights reserved.