Hasselt – MyCellHub welcomes Jacques Parlongue as CEO starting from today. Jacques brings his expertise and track record in managing successful international scale-ups, including growing ten-fold the company N-SIDE during his last assignment. MyCellHub is a modular data management and analysis (SaaS) platform that streamlines and automates complex workflows in the bio-manufacturing industry. It can count among its customers companies like eTheRNA immunotherapies, RD-Biotech, TRU Cleanroom Cleaning and EXO Biologics.
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.
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?
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.
You’re on a mission to bring the latest biotech wonder to the patient and work on the edge of what is biologically possible. But you are manually recording your processes with pen and paper? Discover what value an electronic batch record could bring you.
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.