Viral Vector Development

Product Description

Cobra is an experienced manufacturer of cGMP viral vector products for gene therapies and vaccines offering - Platform Process Development and Scale Up - GMP Cell Banking & Viral Seed Stocks- GMP Manufacture- Viral Vector Analytical Development & Qualification- Stability Studies

COBRA BIOLOGICS

  • GB
  • 2015
    On CPhI since
Specifications
  • Selling Points
    Quality Service; Reputation
  • Supplied from
    United Kingdom

COBRA BIOLOGICS

  • GB
  • 2015
    On CPhI since

More Products from COBRA BIOLOGICS

  • Microbial Proteins

    Product Microbial Proteins

    We provide microbial strain development services from any gene to any source utilising proprietary or free to use cytoplasmic accumulation and periplasmic secretion systems; the combination of ORT®, our antibiotic-free maintenance system, and the bacteriophage-free T7 system enhances high-yield protein expression for therapeutic and biosimilar products.
  • Non-Clinical Material Production

    Product Non-Clinical Material Production

    Contract manufacturing / process development
  • Fill Finish

    Product Fill Finish

    Our state-of-the-art, flexible Fill Finish facility, acquired by Cobra from UniTech Pharma at the end of 2011, expands the current service offering to include the production of sterile drug products and freeze drying / lyophilisation for clinical trials and commercial supply. Small molecules, DNA, recombinant proteins and antibodies can be filled in either single-use syringes or injected vials, to meet rigorous sterility requirements in accordance with aseptic manufacturing procedures.

  • Platform Process Development & Scale Up

    Product Platform Process Development & Scale Up

    COBRA BIOLOGICS offers a wide range of services which includes platform process development & scale up.

    Development of fully closed systems; sterile processes for whole cell parenteral products

  • Traditional stainless steel systems for oral products
  • Development of robust and scalable manufacturing processes
  • Media development and optimisation (animal component free)
  • Optimisation of harvest parameters to improve both quality and productivity
  • Formulation
  • Development of sterile harvest concentration & cell washing systems
  • GMP Cell Banking

    Product GMP Cell Banking

    Cobra can provide cell banking of customer's mammalian and microbial products, as well as insect cells, yeast cells and virus products to support Phase I, II & III clinical to commercial scale supply as a stand-alone service. Working within cGMP Manufacturing regulations, we can maintain both Master & Working Cell Banks (MCB & WCB), as  well as Master & Working Viral Seed Stocks (MVSS & WVSS).

  • Stability Studies

    Product Stability Studies

    Cobra offers stability testing of customers’ DNA, protein, virus and cell products as a stand-alone service. Materials are tested according to ICH guidelines for Drug Substance & Drug Product, with the option of forced degradation and stability to support pre-formulation studies.

    As part of the Quality Assurance process (material shelf-life assessment), products are tested according to ICH guidelines. The effects of different levels of light, heat, humidity and oxygen levels, as well as a broad range of pH levels, are examined. These studies help to determine the effect of external factors on the active component within a customer’s product.
  • cGMP Manufacturing

    Product cGMP Manufacturing

    COBRA BIOLOGICS offers a wide range of services which includes GMP manufacturing for DNA, mammalian protein, microbial protein, viruses microbiota and fill finish.

    Features: it helps to ensure the release of quality products for customers' preclinical and clinical trials through to commercial supply. Processes are clearly defined and controlled to ensure compliance, clear records are maintained and any deviations are investigated and documented. It helps to ensure testing for all viral manufacturing programmes to ensure quality products for customers' preclinical and clinical trials through to commercial supply.

  • Gene Therapy

    Product Gene Therapy

    Cobra Biologics provides a full range of services from gene cloning to cGMP manufacturing for pre-clinical through to Phase III clinical trials. Services Overview: -Viral Vectors - DNA Types High Quality (HQ) plasmid suitable for AAV and Lentivirus production GMP DNA manufacturing for Gene Therapy GMP DNA for production of viral vectors - cGMP Cell Banking - Process Development Services - Analytical Development & Qualification - GMP Services - ill Finish- Quality Assurance and Regulatory Support
  • Microbiota / Live biotherapeutics

    Product Microbiota / Live biotherapeutics

    Cobra provides expert process development and scale up of customers’ microbiota products, manufacturing to cGMP standards for pre-clinical, clinical and commercial scale.
  • Aseptic Pharmaceuticals Manufacture

    Product Aseptic Pharmaceuticals Manufacture

    Our comprehensive service offering includes the capability for producing sterile drug products, utilising full disposable systems and meeting rigorous sterility requirements in accordance with aseptic manufacturing procedures.
     
    With batch sizes from 1 to 100 litres, Cobra can manufacture for clinical trials through to commercial scale supply, with parenteral products filled in single-use syringes or injected vials.
  • Pre-Filled Syringes

    Product Pre-Filled Syringes

    Pre-sterilised, pre-filled, single-use syringes ranging from 0.5ml to 10ml can be filled at a rate of up to 4,000 syringe units per hour.
  • COBRA BIOLOGICS resources

    • News Cobra Biologics to manufacture plasmids for COVID-19 vaccine trial

      Scancell’s DNA vaccine could provide long-lasting immunity against COVID-19 by generating protection against this and new strains of coronavirus.
    • News Cobra Biologics completes production of master cell banks for epilepsy gene therapy drug candidate

      This milestone secures future production of CombiGene's CG01 drug candidate to treat drug-resistant focal epilepsy.
    • News Cobra Biologics delivers final plasmids for CombiGene's epilepsy project

      Further milestone paves the way for production of novel gene therapy drug candidate designed to treat drug-resistant focal epilepsy.
    • News Cobra Biologics Receives the Queen’s Award for Enterprise in International Trade

      The UK’s most prestigious business award granted in recognition of outstanding achievement in the export of services for gene and immunotherapy products. Cobra Biologics ("Cobra")  today announced that it has been awarded the Queen’s Award 2018 for Enterprise, in the International Trade category. The prestigious award is in recognition of Cobra’s commercial success in providing services to its global customer base. Now in their 53rd year, the Queen’s Awards have a long history of recognising exceptional UK businesses and Cobra will be attending a reception at Buckingham Palace followed by a presentation of the Award by a representative of Her Majesty The Queen at Cobra’s UK facility later in the year.
    • News Cobra Biologics and Symbiosis Awarded £1.9m ($2.5m USD) Innovate UK Grant

      Cobra Biologics, an international contract development and manufacturing organisation (CDMO) of biologics and pharmaceuticals, and Symbiosis Pharmaceutical Services, a contract manufacturing organisation (CMO) specialising in sterile Fill Finish, today announced that they have been awarded a 16-month collaborative grant of £1.9m from Innovate UK. The grant will position the partner companies as globally recognised centres of excellence in the field and firmly establish commercial viral vector manufacturing capabilities within the UK. The joint investment project, costing £4.8m in total, aims to develop world leading capabilities for clinical and commercial production of gene and immunotherapy viral vectors for both drug substance and drug product manufacturing.
    • News Jan 18 Cobra Biologics awarded £2.6m ($3.4m USD) from Innovate UK

      Cobra Biologics (Cobra) announced that it has been awarded £2.6 million ($3.4 million) capital infrastructure investment by Innovate UK. The award has been made under Innovate UK’s Industrial Strategy boost for UK medicines with £70 million of funding to help develop new treatments. The investment will go towards a £5 million development project, which forms part of a wider £15 million company expansion announced by Cobra in 2017, to advance world leading capabilities for clinical and commercial production of viral vectors and DNA, vital for gene therapy and immune-oncology programmes.
    • News Cobra Biologics Embarks On £15m (165m SEK) Gene Therapy Manufacturing Operations Expansion

      Over the next two years Cobra will invest up to £15m (165m SEK) on a phased expansion plan, supporting the company’s R&D expertise in developing rapid and cost effective viral vector and DNA plasmid production platforms.

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