What is a batch record?

Since every patient deserves drugs that are safe and efficacious, quality is key for any manufacturer of (bio)pharmaceuticals.

But how do you know that a drug was produced in a way that its quality is up to standards? Strict regulation was put in place, known as Good Manufacturing Practices (GMP), which requires that the production process is thoroughly documented. This is where the batch record comes into play. It is this record that allows manufacturer to answer questions that are critical to product quality, such as; Who did what, and when? Which materials were used? Which procedures were followed and were the results within specifications?

Read more

MyCellHub is awarded €200K Eurostars grant to advance streamlining of biomanufacturing processes

Developing an efficient cell therapy production platform

Cell therapy (CT), using cultured human cells, is a treatment option that holds great promise for curing a vast number of difficult-to-treat diseases, such as diabetes, Alzheimer’s and ALS, and also for skin reconstruction or promoting recovery from an infarct. While cell therapies are currently moving into clinical practice, the production of cells on a commercial scale poses a major economic and industrial challenge. The new Eurostars project Bioscale will focus on the SCINUS expansion system, for cost-efficient cell culture, to achieve standardised CT production, ultimately leading to improved quality consistency in CT development and a reduced cost of CT commercialisation.

Read more

Could gene therapy be the key to a fast coronavirus vaccine?

Could gene therapy be the key to a fast coronavirus vaccine?

It generally takes a decade to bring a new drug candidate from the initial research phase to final market approval. This is a painstakingly long process, and especially during fast moving pandemics as we currently witness with the novel coronavirus, one might wonder how this timeline could be shortened.

Read more