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Javier Lozano, PM Group’s expert on Single Use Designs and standardisation, talked to BioProcess International about how given current supply issues caused by the COVID-019 pandemic, suppliers have been struggling to keep up with demand.

“It is widely accepted that standardisation of Single Use (SU) designs and assemblies would be beneficial to the industry, providing simpler, faster and lower cost solutions. However, as SU technology become more widely adopted within the biopharma industry, suppliers may struggle to keep up with demand. This has been particularly evident given the current supply issues caused by the COVID -19 pandemic. A widely adopted SU Standardisation approach is needed to alleviate SU supply issues. This would not only benefit the biopharma industry by helping to ensure production but ultimately, it would help patients as well.

Barriers to adoption

Although there have been attempts to influence widespread adoption of SU Standardisation through industry bodies such as BioPhorum, ASTM, and even individual suppliers, most have been unsuccessful in achieving the ultimate goal. This is due to the many barriers preventing substantial adoption, including:

  • Too difficult/complex to change validated production assemblies requiring significant resources
  • Inconsistent approaches to assembly design and procurement within company networks
  • Reluctance by SU suppliers to adopt industry-wide Standardisation effort – suppliers typically want to provide their own, differentiated components
  • End-users usually promote their own chosen platform, instead of taking a more holistic industry-wide approach.”

The whitepaper was co-authored by PM Group Technical Director, Austin Lock.

Read more in BioProcess International