AT-Closed Vial® and Container Closure Integrity during Cryogenic Storage
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Together aligning the needs of cutting-edge biologics with cutting-edge processes
Challenges
The shift of the R&D focus from small molecule to biologic-based drugs shaped the current state of pharmaceutical industry: today biologics are dominant in the pipeline of big pharma and became standard of care in the field of diabetes, autoimmune diseases and oncology.
The biotech products are in further evolution and bring hope to new patient populations.
The manufacturing technologies for biopharmaceuticals overall haven’t aligned with this development pace: the processes are still labor-intensive and require significant validation effort.
Cancer Immunotherapies
Cancer immunotherapy targets and eliminates cancer cells by artificial stimulation boosting the body's immune system.
Numerous novel strategies, besides adoptive cell therapies, are in development and in clinical practice thanks to their ability to ensure durable clinical response : oncolytic viruses, monoclonal antibodies, cancer vaccines, checkpoint inhibitors.
The fill & finish step, conventionally associated with contamination risks, is particularly impacted, due to the high value of the product at this step.
Fast process development, manufacturing deployment and it’s further efficient scalability from Phase I to commercial is essential for cancer immunotherapies, to reduce time-to-market and bring the products to the patients.
Discover how our scalable fill & finish machines bring strength to the manufacturing roadmap of cancer immunotherapies globally, while cutting the validation cost.
Inspiring cases studies
Our technologies bring consistency and robustness to the fill and finish processes of cell and gene therapy players globally
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