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Cangene's Research and Development facility is located in Winnipeg, Manitoba. This group is responsible for innovative developments and subsequent validation of therapeutic products. The R&D group focuses on early stage evaluation and development of new products as well as process scale-up, assay development and validation. |
The Research and Development group has experience in cloning proteins and antibodies in both bacterial and mammalian cell expression systems and have developed processes for hyperimmune and recombinant products.
Bioprocessing and Formulation Group
This group has a broad-ranging expertise in the
development of recombinant protein therapeutics in the pre-clinical,
clinical and NDS phases of a product's lifecycle. This extends
to the development and validation of purification processes,
characterization of proteins using state-of-the-art analytical
techniques as well as significant expertise in analytical
assay development and validation. In addition, the group
has developed a number of lyophilized and liquid formulations.
Product Development Group
The group has extensive knowledge and expertise
in cGMP and aseptic manufacturing, process validation, plasma
protein purification, plasma product safety and regulatory
issues in North America and Europe.
The group is comprised of scientists and technologists
that provide development support for two of Cangene’s
innovative business sectors:
Hyperimmune IgG Products/Process
- Process Validation
- Virus Validations
- Development of new processes and improvement to current
process
- Scale-up development
Contract Manufacturing
- Technical transfer
- Preparation of batch records
- Implementation of contract methods
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