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Sourcing Inquiry Logo Medipolis GMP Ltd.

Medipolis GMP Ltd.

Regions
Europe
Countries
Finland
Size
n.e.
Specialty
Human Medicines, Biopharmaceuticals
Service category
Contract manufacturing, filling and packaging, Pharmaceutical process development and validation, …
Service category
Contract manufacturing, filling and packaging, Pharmaceutical process development and validation, Quality management services, Training and education, Partnering/collaboration for drug dossiers, patents, drug candidates, medical technology, Sourcing of APIs, Excipients, Intermediates, bulk drugs
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Key services

Services

Manufacturing

Upstream and fermentation. Medipolis GMP disposes of facilities for the cGMP production of therapeutic recombinant proteins and other biologics. Medipolis GMP’s fermentors capacity is ranging from 15 liters to 750 liters. We have expertise especially in following production systems:

* E.coli
* Bacillus subtilis
* Pichia pastoris

Downstream processing. We offer tailor-made solutions to meet the specific needs of our custormers product purification. For intra- or extracellular product downstream processing, we offer:

* Homogenisation (high pressure cell disruption)
* Tangential flow filtration
* Centrifugation
* Chromatography
* Freeze-drying

Regulatory Support and other Quality Assurance Services

Analytical quality control services. An appropriate quality system and analytical methods are critical components in the development and production of biopharmaceuticals. Our Quality Assurance (QA) and Quality Control (QC) teams provide material characterisation, testing and analytical method development services together with extensive GMP manufacturing support to guarantee compliance with current rugulations. The staff is highly qualified and regulary trained according to GMP guidelines.

GMP compliance is ensured by:

* A production licence granted by the National Agency of Medicine
* Regular inspections by the Finnish regulatory authorities
* Experience with national regulatory authorities, the FDA and EU
GLP/GMP documentation
* Equipment and process validation
* Validation of analytical methods according to appropriate guidelines
* Internal audits of manufacturing and laboratory facilities and operations

Other Services:

GMP documentation services
* Technical support
GMP Training
* Consulting. Our staff can visit your company and give advice and assist you to develop and set up your own fermentation process

Approvals, Certificates, Authorisations

  • FDA and EU cGMP
  • GLP

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