A history of regulatory expertise at Modality Solutions

A history of regulatory expertise at Modality Solutions

A history of regulatory expertise at Modality Solutions

Prior to the start of Modality Solutions, the co-founders collaborated with their biopharmaceutical manufacturing peers to develop the first detailed approach on addressing the early regulatory requirements for the cold chain industry. Through the Parental Drug Association (PDA), they collaborated to produce four different technical reports. These foundational documents were the first attempt to put forth a practical approach on how to meet global regulatory requirements.

In the pharmaceutical industry at the time, each company was testing its thermal packaging in a different way. A group led by the founders of Modality Solutions collaborated with ISTA to develop a new thermal profile (ISTA 7E), identified industry best practices and set the standard for a consistent approach to thermal packaging qualification. The previous thermal profile (ISTA  7D) was not based on measurable data nor have any meaningful statistical analysis conducted in its design was a stochastic model that tested the extremes but was a rather unnatural rotation through high and low temperatures.

Guide to regulatory Expertise

The team led by Gary Hutchinson, now the president of Modality Solutions, collected hundreds of thousands of data points in the cold chain and assembled a thermal profile that was, instead, underpinned by data and statistically sound. The data-driven model that was much closer to the actual thermal challenges that shippers would encounter. Through ISTA, our founders developed a standard approach that the industry (both pharmaceutical manufacturers & thermal packaging manufacturers) agreed to adopt.

  • PDA Technical Report No. 39 Revised 2021 (TR 39) Guidance for Temperature-Controlled Medicinal Products – Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment
  • PDA Technical Report No. 46 (TR 46) Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to the End User
  • PDA Technical Report No. 52 (TR 52) Guidance for Good Distribution Practices (GDPs) For the Pharmaceutical Supply Chain
  • PDA Technical Report No. 53 (TR 53) Guidance for Industry: Stability Testing to Support Distribution of New Drug Products
  • ISTA Standard 20 Revision 2 (STD-0020)
  • Testing Standard for Thermal Transport Packaging Used in Parcel Delivery System Shipment (STD-7E)

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