Manufacturing

Our process is what defines us

Biologics and biosimilars tend to be labile and sensitive to changes in the manufacturing process. Changes to source materials, manufacturing processes, equipment, or facilities can result in significant unexpected changes to the intermediate and/or final product.

A well-defined manufacturing process with its associated process controls ensures a consistently acceptable biosimilar that meets specific requirements.1

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Fundamental principles of biosimilar manufacturing 1

Engineering a biosimilar

On the basis of a reference biologic’s critical quality attributes (CQAs), a biosimilar is engineered to be highly similar in terms of host cell proteins, product attributes, variants, drug release, strength, process impurities, and stability profile.1,3

Characterization and comparative studies

High similarity in analytical and pharmacokinetic/pharmacodynamic (PK/PD) data between the reference biologic and the biosimilar indicates a lower risk of clinical differences.1

Quality standards in manufacturing

Rigorous quality standards throughout the manufacturing process and extensive risk assessments help ensure product safety and efficacy.1

Biologics and biosimilars tend to be labile and sensitive to changes in the manufacturing process. Changes to source materials, manufacturing processes, equipment, or facilities can result in significant unexpected changes to the intermediate and/or final product.

A well-defined manufacturing process with its associated process controls ensures a consistently acceptable biosimilar that meets specific requirements.1

Manufacturing process critical control points are identified to detect process changes that may affect CQAs.1

Strategies to ensure biologic or biosimilar product quality and consistency throughout the manufacturing process include the following:2

  • Product characterization
  • Adherence to good manufacturing practice (GMP)
  • Validated manufacturing processes
  • Raw materials testing
  • In-process testing
  • Stability testing

References: 1. Health Canada Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs. Accessed May 24, 2018. Available at: https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/brgtherap/applic-demande/guides/seb-pbu/seb-pbu-2016-eng.pdf. 2. ICH. ICH Harmonised tripartite guideline. Specifications: Test procedures and acceptance criteria for biotechnological/biological products Q6B. 1999. Accessed May 24, 2018. Available at: http://www.ich.org/ fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q6B/Step4/ 3. ICH. ICH Harmonised tripartite guideline. Pharmaceutical Development Q8R (R2). 2009. Accessed May 24, 2018. Available at: https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/prodpharma/applic-demande/guide-ld/ich/qual/q8r2-step4etape-eng.pdf.

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