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...
Filter manufacturers in the medical field – Which are the sterile membrane filters you can trust? Small particles or molecules are removed by membrane filtration in order to obtain absolutely sterile products. The sterile filtration in the pharm...
The logistics branches of biopharma companies experience a major paradigm shift. The supply chains for conventional small molecule drug products and biologics involve the acquisition of raw materials, the manufacturing process of pharmaceutical su...
Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on genes, tissues or cells. Accordingly, they can be classified into three main types, namely gene therapy tissue engineered- and somatic-cell therapy medicin...
Cell and gene therapy (CGT in short) is a new and promising type of immunotherapy for patients suffering from certain types of cancer and lymphoma/leukemia. It is among the treatments of Advanced Therapy Medicinal Products, in short ATMP. Any ex-v...
The concept of end-to-end solutions is transforming industries with a focus on seamless and efficient processes. For biopharmaceuticals this includes filling, freezing/thawing and transporting sensitive drug substances by using a single platform. ...
Name one biopharmaceutical manufacturing company which does not need containers for storage, transportation and transfer of hundreds of litres of liquids in 3D single-use bags. Is there even one? Biopharma totes are functional supporting devices t...
In recent years cell and gene therapies (CGT) have proven to be promising approaches to personalized medicine. Patients needing a cell and gene therapy as an advanced therapy medicinal product (ATMP) rely on their treatment being ready as soon ...
It's no secret that pharmaceutical substances are of high value in most cases. Even a small defect rate of biologics or ATMPs causes high financial losses. It is therefore of great importance to establish solid process logistics around freezing, t...
Biopharma solution provider Single Use Support announces an order from Genezen, a cell and gene therapy Contract Development and Manufacturing Organization (CDMO). The Indianapolis-based CDMO has ordered RoSS.FILL CGT to fill lentiviral vectors in...
The quick and efficient aseptic filling transfer of highly valuable and at the same time extremely sensitive drug substances is a critical process step. While in the past pharmaceutical and especially biopharmaceutical manufacturers have relied...
Infiltrating product solutions from life science companies or any other supplier into Biopharma environment is justifiably not so simple. It is the primary goal to avoid contamination and insterility in clean rooms. One of these approaches to infi...
In recent years, if not decades, gene therapies have proven to be key drivers of growth in the pharmaceutical industry. Production is often complex, challenging manufacturers with new hurdles: The fragile nature of medical drug products has fo...
