Freezing drug substances to ultra-cold temperatures is a standard step in biopharmaceutical manufacturing. Yet, beyond simply cooling, it’s the critical quality attributes (CQA), like product safety, consistency, and process efficiency, that trul...
Single-use bioprocessing has recently experienced tremendous growth in biopharmaceutical manufacturing market share and enjoyed technological advances ranging from material properties, to implementation of Industry 4.0. In contrast to traditional ...
ADCs (Antibody Drug Conjugates) are an incredibly promising treatment for cancer or autoimmune diseases - but they come with challenges in manufacturing and safe handling. Controlled freezing is an increasingly important topic in ADC production. ...
When CDMOs plan to expand their production capacities based on single-use technologies, it is tempting to either implement existing spare platform systems or simply "copy paste" used equipment - especially for greenfield facilities. However, it is...
Cell monolayers are an ideal method and widely used in the discovery of new drug compounds and the study of cell biology. Until now, there was no cryopreservation technology available to store cell banks pre-plated commercially. The conventional a...
The processes of cryogenic freezing and cryopreservation are considered essential in biotechnology for the conservation of biomaterials. Regenerative medicine and other disciplines in life sciences were allowed to make huge leaps in the treatment ...
CMO and CDMO are forced to collect a series of platform systems for biomanufacturing in different primary packagings: single-use bags, bottles and vials. The handling of different primary packagings results in a lack of standardized process sol...
With the emergence of many innovative approaches in the biopharmaceutical industry in recent years, life sciences companies have needed to put increasing efforts into pharmaceutical cold chain management. Many newly developed, highly sensitive ...
When dealing with the proper handling of some of the most innovative biologics – whether they are already on the market or still in the stage of clinical trials –, ultra-cold freezing and storing is a necessity. Since many pharmaceutical substanc...
Hybrid solution for drug freezing and thawing involve the use of both primary packagings, single-use bioprocess containers and bottles, the latter also known as rigid containers or PE containers. Biopharmaceutical manufacturers and CMOs typical...
Mastering the complex CAR T manufacturing process and the associated supply chain challenges in the cell and gene area are the major bottlenecks during the large-scale commercialization of highly promising CAR T cell products. This autologous ...
Gene therapy manufacturing continues to cause a stir in the biopharma industry. Gene therapies have become a highly promising field of groundbreaking next generation treatment approaches that use personalized therapies for rare diseases and allow ...
In many branches and sectors, Industry 4.0 has long gone from being a buzzword to reality: In Pharma 4.0 intelligent industrial applications and IoT enable players in the bioeconomy industry - an umbrella term for biomanufacturing and biotechnolog...
