Sensitech helps PharmaCell keep its cool
specialist Sensitech for the cold chain management of their cell
culture products, allowing it to ensure compliance with GMP
regulations.
Cold chains are important because if there is a breakdown in the supply and distribution chain at any time, temperature-sensitive products may lose their quality, freshness and integrity.
PharmaCell grows cells for third parties which can be used as human cells for product development, clinical testing or initial stages of commercialisation, so the company cannot afford to have its products jeopardised at any time during the delivery process from the lab to the clinic.
Since cell tissue or cells are extremely temperature-sensitive, the Maastricht-based firm decided to recruit the services of Sensitech to monitor, document and archive temperature information of their products.
"In Europe standards with regards to cold chain management are somewhat vaguer than they are in the US, where clear guidelines for good storage and shipping practices were published by the US Pharmacopeia (USP) last November," Sensitech spokeswoman Francis Stalder told In-PharmaTechnologist.com.
"We are promoting these USP standards and also make sure all our clients comply with GMP requirements."
For transports of muscle cell tissue between its Netherlands-based production facilities and the receiving hospitals in Europe, Asia and Africa, PharmaCell is using Sensitech's TempTale monitoring equipment to secure compliance.
This way the company believes it can reduce losses, facilitate the acceptance process, and ultimately strengthen its bottom line by allowing fast and accurate flow of data straight from the loading dock to the corporate office.
"As we are dealing with unique cell tissue and not with a generic product that can be replaced, it is critical that we monitor the cells throughout our supply chain as part of our quality management system," said Rene Lardenoije, president and CEO of PharmaCell.
"We simply cannot afford to lose the cells tissue due to temperature failures."
Among the services PharmaCell provides are cell banking and storage, process development, GMP cell culturing for cell therapy and production of recombinant proteins.
