Commercial Manufacturing
In the commercial manufacturing stage, the ATMP is produced to support routine patient treatment following regulatory approval. Manufacturing activities are conducted under Good Manufacturing Practice (GMP) to ensure consistent product quality, safety, and regulatory compliance. Robust manufacturing processes, quality controls, and supply chain systems are essential to provide a reliable supply of the therapy and ensure that patients receive the product as intended.
Dastex Group GmbH
Dastex Group ensures contamination-free processes—with expert knowledge, innovative products and sustainable solutions for GMP cleanrooms. As leading provider in Europe, supporting you personally, practically and as a partner—from cleanroom clothing to cleaning solutions.
VR as a training tool Evaluation
To better understand the potential of virtual reality as a training tool, SCALE conducted an independent evaluation of FourPlus Immersive VR training platform. Participants from both industry and academia tested laboratory and cleanroom training modules!
Arthro Diagnostics
Biomarkörer som avslöjar ledens aktuella hälsotillstånd och ger veterinärer värdefull hjälp att fatta rätt behandlingsbeslut.
Getinge
Getinge is a global medtech company providing advanced manufacturing, cleanroom, and aseptic processing solutions that support the development and production of ATMPs, including cell and gene therapies.
Good Manufacturing Practice (GMP) for ATMPs – Practical Application
This training course is designed for individuals who will be involved in the manufacturing or handling of Advanced Therapy Medicinal Products (ATMPs) within a GMP-regulated environment. The course provides practical examples of how Good Manufacturing Practice (GMP) is applied to ATMPs and covers topics including aseptic processing, hand hygiene, cleanroom environments, gowning procedures, good documentation practices, as well as aseptic operations and cleaning in cleanrooms. The training is based on current EU GMP requirements and relevant ATMP-specific guidelines. A basic understanding of GMP, or experience working in a GMP-regulated environment, is advantageous.
AstraZeneca
AstraZeneca is global pharma company with strong connection to Sweden through both big research and manufacturing sites. Their development of ATMPs includes CAR-T and TCR-T treatments, as well as drug delivery platforms. Their research as well as product development is spread out globally with over 80 000 employees over the world.
GMP Basics ATMP Edition
This training will give you an introduction to GMP requirements for both manufacturing of investigational ATMP and ATMP intended for the market.