Custom Solutions

As Scientists Helping Scientists, STEMCELL Technologies leverages our many years of experience and broad range of product development and manufacturing expertise to develop tailor-made, customised solutions to support your unique cell separation and cell culture needs.

From custom packaging or formulation to meeting higher regulatory requirements, we will work with you to deliver a custom product specifically designed for your intended application.

STEMCELL Custom Solutions Capabilities

  • Custom cell separation cocktails or kits
  • Modified media formulations
  • Custom packaging (e.g. bags, bottles, vials)
  • Custom labeling (e.g. private label, OEM)
  • Higher compliant solutions to meet clinical or diagnostic requirements (e.g. custom manufacturing processes, use of single-use technology, use of dedicated equipment or facilities)
  • Extended or customized documentation (e.g. Certificates of Origin, BSE/TSE risk statements)
  • Additional QC testing (e.g. endotoxin testing, mycoplasma testing, stability studies)
  • Additional quality oversight
  • Regulatory support or custom product registration (e.g. CE Mark, Master Files)

Values

  • Streamlined project management-based approach with a strong emphasis on starting projects quickly and completing them on time.
  • Our multidisciplinary team of experts have the know-how and flexibility to address your unique needs in a collaborative manner.
  • Over 20 years of experience in the development and manufacture of cell culture and cell separation reagents.
  • ISO 13485-certified Quality Management System with a proven track record of unsurpassed product quality and the ability to flex our quality systems to meet your needs. For more information about our QMS, please review our Quality Statement.

Fast and Easy Custom Cell Separation

STEMCELL Technologies can rapidly respond to your custom cell separation needs. With over 20 years of cell separation expertise, an extensive range of antibodies, and a variety of cell isolation methods, STEMCELL will work with you to create a custom product that enables the isolation of your desired cell type.

Researchers working with rare cell types, non-standard species, and special applications can easily isolate cells of interest with one or more of the following customization options:

  • Tailor-made Cell Isolation Kits
    Choose your starting cell source, species, and your desired cell type or the cell surface antigens you would like to target and let STEMCELL design a kit for you.
  • Modification of Standard STEMCELL Cell Separation Kits
    Modify an existing STEMCELL kit to add or remove antibodies from the cocktail, change concentration, or switch components.
  • Customized Packaging
    Our packaging options include vials in a variety of volumes and formats, customized labelling, and bulk packaging.
  • Additional Quality Control Tests
    STEMCELL can perform a variety of QC testing, such as sterility and performance testing, on a custom basis.

Contact us at info@stemcell.com or contact your local Sales Representative and cell isolation expert, to discuss your specific cell separation needs.

Custom Cell Culture Media

STEMCELL Technologies is able to work with you on a case by case basis to meet your cell culture needs. In many cases, you will be referred to our Key Relationship Management Program to assist with designing your custom cell culture medium product.

To create a tailored cell culture solution, researchers can chose one or more of the following customization options:

  • Modification of Standard STEMCELL Cell Culture Medium
    Modify an existing STEMCELL medium to add or remove components (subject to review).
  • Customized Packaging
    Our packaging options are flexible and are available in a variety of volumes and formats, including vials, bottles, and bags.
  • Additional Quality Control Tests
    STEMCELL can perform a variety of additional testing, such as endotoxin and biocompatibility testing.

Contact us at info@stemcell.com or contact your local Sales Representative and cell culture expert, to discuss your specific cell culture needs.

Key Relationships Management Program

For more complex requests, such as higher regulatory compliant product manufacture, custom product development, or contract services, you will be referred to one of STEMCELL Technologies’ Key Relationships Managers for initial discussions regarding your custom requirements. These specialists are trained to provide information and feedback about STEMCELL’s services and capabilities, and to obtain a comprehensive overview of your requirements in order to design the best solution to meet your needs.

Early in the project design phase, the Key Relationships Manager will consult with a cross-functional team of experienced employees from various departments, including Research and Development, Manufacturing, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, and any other discipline deemed necessary to ensure accurate design of your project objectives. After execution of the appropriate contracts and confidentiality agreements, the project will move to the implementation phase where a dedicated team will be assigned to your project.

The Key Relationships Manager will guide you through this collaborative process, and will be your single point of contact. As the dedicated project manager, he or she will keep you informed and involved in the progress of the project from initiation to completion. The primary objective of the Key Relationships Manager is to ensure delivery of the project in a timely manner, on budget, and to the quality standards you require for your application.

Under the Key Relationships Management Program, STEMCELL may be able to support the use of our products as ancillary materials (as defined under USP <1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products) under an approved Investigational New Drug application, Clinical Trial Authorization, Clinical Trial Application, or equivalent regulatory filing.

Contact us at info@stemcell.com or contact your local Sales Representative to discuss your specific regulatory or product requirements.

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