How do digital workflows enable review by exception?

GMP or Good Manufacturing Practices require to carefully document processes and workflows executions. Any production and control record needs to be reviewed so that failures or deviations can be detected before the product is released. These documents can be hundreds of pages long filled with technical data. Reviewing for manufacturing mistakes, illegible entries, missing signatures or other oversights is therefore not an easy task. It is key to prevent the ensuing errors that go hand in hand with repetitive manual tasks which require great attention to detail. Additionally, efficiently passing on these documents for reviews and corrections between operators, Quality Control and Quality Assurance can be both a document control and a logistical challenge.

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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?

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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.

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MyCellHub raises € 1.1 million to help biotech companies manage production data

MyCellHub, an innovative data management and analytics platform for the production of biopharmaceuticals such as cell and immune therapies raises €1,1 million by Noshaq, The Faktory, Gemma Frisius Fund and The CoFoundry. The investment will help the KU Leuven spin-off to accelerate the launch of the platform. The MyCellHub ‘software as a service’ platform is an app that uses interactive work instructions to assist operators in sterile production environments and which automates data collection and reporting tasks. This provides significant efficiency gains, especially as more than 90% of bio-manufacturers still report their processes on paper.

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