About us

Vibalogics offers process development, cGMP manufacturing and fill/finish for companies developing therapeutic biological products with a specific focus on oncolytic viruses and viral vectors to be used as virotherapies.

Our services include:

  • Feasibility assessment

  • Technology transfer

  • Process development

  • cGMP manufacturing

  • Formulation/blending

  • Fill/Finish including lyophilization

  • QC analysis

  • Product release

    With a modern facility based in Germany and capacity to grow with our clients, the facility is capable of handling BSL-2 organisms for all activities.

    In addition to cGMP manufacturing, we develop, qualify and validate product-specific, EP and USP analytical methods for use as in-process controls or product release assays as part of a manufacturing project or as a stand-alone service.

    The primary goal of the company is to offer a full range of development and manufacturing services, underpinned by excellent quality and a transparent customer experience.

Products and services

VIRUS PRODUCTION (CELL & EGG BASED)

  • Cell banking and characterization

  • Virus seed stock generation and characterization

  • Feasibility studies and productivity optimization

  • Genetic stability studies

  • Assay development including infectious particle, genomic virus particle and total particle

  • Primary cell culture (CEFs) suitable for viruses such as MVA

  • Production of oncolytic viruses and gene vectors

  • Single-use, scalable technologies for cGMP manufacturing

  • cGMP virus production on SPF eggs

    cGMP FILL & FINISH

  • Liquid and lyophilized products up to BSL-2

  •  Development lyophilizer for non-GMP batches and formulation/ Lyo. cycle development

  • Manufacturing batch scale:

    o Manual filling of up to 1,500 vials

    o Automatic filling of up to 30,000 vials

    o Lyophilization of up to 3,000 vials

  • Semi-automatic visual inspection

  • Packaging and labelling

    QUALITY CONTROL

  • Development, establishment and cGMP performance of compendial and customer-specific tests

  • Stability testing according to ICH guidelines

Address
Vibalogics
Zeppelinstr. 2
27472 Cuxhaven
Germany

Phone: +49 4721 565400
Internet: www.vibalogics.com
E-mail: Send message

Contact person

John Shaw
Head of Business Development and Marketing
Phone: +44 7590 117729
E-mail: Send message

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