cobra:bio

Project Management

Dedicated Project Manager

Dedicated multi-functional project teams

Detailed timeline planning and milestone tracking

Program managed by single point of contact

Regular process update through telecom or face-to-face meetings

Risk management

Cell Line Development

Molecular biology

Cloning (any gene from any source)

Expression vector development

Proprietary technology:

Rapid mammalian protein production, UCOE

Qualified strains:

Sf9 & Hi5 (Baculovirus)
CHO
Drosophila S2
GS-CHO hybridomas
Myelomas
PER.C6

Stability testing

Vector development: free to use and proprietary systems

Cell lines: CSL 503, HEK 293, PER.C6, HEK 911, Vero Sf9 & Hi5

Qualified viruses: adenovirus (human & ovine), baculovirus, HSV, lentivirus & reovirus

Vector development: plasmid and cell line construction (insect & mammalian host cells)

Virus rescue

Characterisation & plaque purification

Genetic stability testing

Bacteria

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)

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

Virus Products

Adenovirus

Baculovirus

Herpes simplex virus

Lentivirus

Reovirus

Production Systems

CHO

Baculovirus

Drosophila S2

NSO

Escherichia coli

Bacillus subtilis

Pichia pastoris

Strain Development

Cloning (any gene from any source)

Cytoplasmic accumulation and periplasmic secretion systems

E.coli Expression System:

antibiotic free maintenance technology (ORT^®)
Bacteriophage-free T7 expression system

Qualified E.coli strains (examples):

DH1
DH1-ORT
BL21
B834

Plasmid stability testing

Expression plasmid and host strain development

E.coli expression systems:

P_trc
P_araBAD
Lambda P_L/P_R
T7

Process Development & Scale Up

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 (including inclusion body purification)

Chromatographic purification

Purification by low pressure chromatography

Formulation development

Fermentation & media development

Evaluation of productivity and optimisation of harvest point

Lysis optimisation (primary recovery)

Non-animal derived components

Proprietary technology:

DNA process (Type II Drug Master File (DMF) with US FDA)

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

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

Sterile harvest & cell washing facilities

Analytical Development & Qualification

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)

reverse phase chromatography ion exchange chromatography size exclusion chromatography western blot activity assays/cell based potency PCR/QPCR SDS-PAGE horizontal & vertical SDS-PAGE IEF spectrometry- (UV/IR/visible) fluorimetry capillary electrophoresis peptide mapping LAL bioburden ELISA residual host DNA/Protein	restriction enzyme analysis free solution capillary electrophoresis RNA analysis by RP-HPLC & Syber Green Host protein analysis by ELISA Host DNA analysis by PCR/QPCR Agarose gel electrophoresis Residual solvents by GC Pico-green particle assays Development of cell based potency assays Plaque assays TCID₅₀ Host cell DNA/Protein Identity by microbiological characterisation of the strain Purity (monosepsis) Strength by determination of viability Activity/infectivity assays
(Out-sourced)
Mass spectrometry Amino acid analysis Amino acid sequencing DNA sequencing RCA Assay

cGMP Manufacturing

Master Cell Bank & Working Cell Bank

Master Viral Seed Stock & Working Viral Seed Stock

Production in stirred tank bioreactors/fermenters,wave bag, roller bottles, spinner flasks, shake flasks & cell factories

Phase I, II & III clinical supplies

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 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

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