Standards

Akron Biotech is deeply engaged in collaborative, industry-wide efforts to create standards for the regenerative medicine industry.

We are a key stakeholder in the Standards Coordinating Body’s (SCB), an organization that works closely with the National Institute of Standards and Technology (NIST) to coordinate and accelerate the development and diffusion of industry standards.

Ongoing SCB projects to which Akron contributes include:

  • Ancillary materials used in cellular therapy production
  • Cell collection standards for cell therapies
  • Characterization of fiber-based scaffolds
  • General guidance on cell counting
  • Rapid microbial testing methods
  • Requirements for cell therapy manufacturing equipment
  • Specification for printability of bioink
  • Transportation requirements of cell therapy products

For more information about the Standards Coordinating Body, please visit www.standardscoordinatingbody.org

We also contribute directly to the development of standards by the International Organization for Standardization (ISO). We are a major contributor to the ISO Technical Committee for Biotechnology (276), which covers the following topics in the realm of ancillary materials:

  • Terms and definitions
  • Biobanks and bioresources
  • Analytical methods
  • Bioprocessing
  • Cell transportation

Publications

Akron Biotech play a leading role in progressing industry discourse around quality, standards, manufacturing, and analytics for advanced therapies and regenerative medicines. Three publications that embody our collaborative approach to solving critical challenges include:

In June 2017, Claudia Zylberberg (Akron Biotech) and Steven Oh (FDA) co-chaired a workshop at the National Academy of Sciences (NAS) entitled “Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies.” The workshop brought together representatives of 24 leading US and international organizations to discuss challenges, opportunities, and best practices associated with defining and measuring the quality of cell and tissue products, and ancillary materials, in the research and development of regenerative therapies.

Key insights:

  • Difficulties characterizing cell-based products means that process analysis and control becomes more important than for traditional biopharmaceuticals
  • Quality attributes must be better understood and quantified, and continuously adhered to throughout process scale-up
  • Ancillary material quality plays an essential role in product reproducibility, particularly where there is significant inter-donor variability
  • SDOs play an essential role in moving the field forward, and must cooperate closely with regulatory authorities

Click here for access to the full workshop proceedings.

Full reference: National Academies of Sciences, Engineering, and Medicine. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. The National Academies Press. (2017). doi.org/10.17226/24913.

The product of conversations at the National Academy of Medicine (NAM) in October 2016, this paper argues that while there are an increasing number of products in the clinical pipeline and on the market, the industry has yet to coalesce around appropriate cell sourcing, manufacturing, and logistics models. However, the recent development of common platforms, functional assays, and robust logistics and supply chain management tools have undoubtedly advanced the translation of various products.

Zylberberg et al. (2017) discuss three major themes relevant to the future of the regenerative medicine industry: manufacturing, ancillary materials, and the regulatory environment. The paper represents a major contribution to industry discourse around the need for alternative manufacturing and supply chain models, the need for greater quality attribute analysis and oversight, and the need for greater standardization that simplifies how we understand and quantify product quality and promotes the development of better regulation.

Key insights:

  • Manufacturing supply chains may evolve into decentralized models, particularly for patient-specific autologous therapies
  • Decentralized manufacturing introduces specific oversight and compliance challenges that industry standards would offer great value in resolving
  • Therapies must be better understood for developers to justify a quantifiable set of critical quality attributes
  • New standards are needed around how quality is measured and how specifications are set
  • Regulation must be reactive rather than proscriptive to enable innovation
  • Standards can facilitate regulatory compliance, as well as support product manufacturability

Click here for online access to the full paper.

Full reference: Zylberberg, C. et al. Manufacturing Cell Therapies: The Paradigm Shift in Healthcare of this Century. NAM Perspect. (2017). doi:10.31478/201706c

A pivotal paper widely referenced by those discussing or implementing quality standards and qualification programs for ancillary materials, Solomon et al. (2016) offers the perspectives of 9 key opinion leaders towards the importance of working with suppliers to qualify each ancillary material for its source, purity, identity, safety, and suitability for a given application.

Key insights:

  • Vendors and suppliers should work together to quality suitable ancillary materials, sharing the burden of increasing compliance
  • The availability of different clinical-grade materials is currently limited, but is expanding over time
  • With a lack of legislation specific to ancillary materials, industry standards should be developed to guide best practice
  • A risk-based qualification framework should be deployed where no agreed standard exists

Full reference: Solomon, J. et al. Current perspectives on the use of ancillary materials for the manufacture of cellular therapies. Cytotherapy 18, 1–12 (2016).