Stability studies

Stability studies
Product Description

Baccinex SA provides a wide range of services which includes stability studies. It offers stability testing according to ICH guidelines in order to support the development program of clients: QC laboratory performs stability studies regularly for development or commercial batches manufactured at Baccinex. Dedicated qualified chambers are installed to conduct stability studies in compliance with ICH requirements: - 20°C ± 5°C, 5°C ± 3°C, 25°C ± 5°C / 60% RH ± 5% RH, 40°C ± 2°C / 75% RH ± 5% RH.

Read more Show less

Baccinex SA

  • CH
  • 2015
    On CPHI since
  • 100 - 249
    Employees
Company types
Contract Service
Manufacturer/Innovator
View company profile

Baccinex SA

  • CH
  • 2015
    On CPHI since
  • 100 - 249
    Employees
Company types
Contract Service
Manufacturer/Innovator
View company profile

More Products from Baccinex SA (7)

  • Development

    Product Development

    Baccinex SA provides a wide range of services which includes development. Due to the large quantity of development batches manufactured at our site, Baccinex has a thorough knowledge in industrial scale-up and adaptation of new process in compliance with regulatory requirements (GMP…). We have the exp...
  • Logistics

    Product Logistics

    Baccinex SA provides a wide range of services which includes logistics. Supply of raw materials: Baccinex provides the majority of excipients and packaging articles needed for production, and the client is generally in charge of providing the API. Storage: In order to offer storage capacities to our client...
  • Lyophilisation

    Product Lyophilisation

    Baccinex SA provides a wide range of services which includes lyophilisation. It has developed a special expertise in the lyophilisation of proteins, peptides and small molecules. The Klee freeze-dryer installed in grade A environment is used for both clinical and commercial applications. Its capacity is 3....
  • Project management

    Product Project management

    Baccinex SA provides a wide range of services which includes project management. It is co-ordinated by the project co-ordinator who is the iterface between the clients and the internal departments. There are different phases like preliminary phase and realisation phase. Each request leads to a feasibility ...
  • Quality control

    Product Quality control

    Baccinex SA provides a wide range of services which includes quality control. It provides full quality control support at each step of projects: Raw materials and packaging articles are sampled and analysed at reception and released for use, specific In-process controls (IPC) per process can be performed: ...
  • Secondary packaging

    Product Secondary packaging

    Baccinex SA provides a wide range of services which includes secondary packaging. Main production activities following primary packaging are done manually which allows it to provide a wide range of packaging services to suit the needs of the clients. Automatic labelling is also possible. Baccinex is able t...
  • Aseptic filling

    Product Aseptic filling

    Baccinex is a Swiss based fill&finish CDMO specialized in development and manufacturing of sterile & lyophilized clinical material for pre-clinical, Phase I, II and III as well as commercial supply batches. Our expertise is forged by 15 years of sterile clinical and commercial material manufact...