West's Scientific Affairs Team

February 24, 2017

On the Horizon: Global Standardization for Biotechnology Applications

Research has been expanding understanding of biological systems at an exciting pace. In parallel, the biotechnology industry has been rapidly evolving as different biological entities (e.g., cellular and gene-based products) are increasingly harnessed as resources and therapeutics. To maximize the global utilization of biotechnology advances and drive further advancement of the industry, standards are needed.

 

Cell technologies in biological research 

 

The International Organization for Standardization (ISO) has convened a technical committee (TC 276) that will address this need by identifying and filling gaps in standardization for biotechnology applications. West has been invited to join TC 276 to contribute its expertise regarding packaging and delivery systems. TC 276 is organized into five working groups that are creating normative and informative standards in the following areas:

  1. Definitions of biotechnology terms used throughout the standards and the industry
  2. Biobanks and biorepositories
  3. Analytical methods and measurements in biotechnology applications
  4. Bioprocessing
  5. Data processing and integration

The initial standards developed will be broad and horizontal in nature, but will provide the basis for more specific, vertical standards that address the goal of world-wide consistency. One committee expert cleverly compares the suite of standards to a well-known fast food chain, in that both seek to ensure consistent quality independent of location. The first standards are expected to issue in 2018. Additional standards will issue continually as needs are identified and participation from concerned industry, governmental and academic parties increases.

West’s commitment to support ISO TC 276, as well as other industry groups (e.g., PQRI, PDA), is an example of its long-standing commitment to products that enable the safest delivery of drug products to patients.

More information about the international ISO TC 276 Committee can be found here.

The US Mirror Committee is administered by the National Institute of Standards and Technology (NIST), click here to learn how to get involved.