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...
Annex 1 of GMP is a set of regulations guiding the manufacturing of sterile medicinal products, setting stringent regulations for biopharmaceutical processes. Within this set of regulations, PUPSIT stands out as a fundamental procedure to ensure t...
Addressing Challenges in Aseptic Filling Accurate and efficient filling of biopharmaceuticals in primary packagings, such as single-use bags and bottles, is crucial. Even the smallest deviations in the filling volume can have a huge impact on ...
The demand for disposable bags is influenced by key industry players who acknowledge the market's requirement for dependable safeguarding of crucial and high-value goods within the biopharmaceutical sector. This includes intermediates as well as f...
Cell viability is one of the cell product quality and regulatory parameter that determines therapeutic efficacy. For example, the FDA mandates a viability threshold of ≥ 80% for the release of CAR T cells. Nevertheless, in clinical trials and in ...
Improving Cryogenic Freezing of a Mammalian Cell Line A study was conducted aiming to optimize the cryogenic freezing process of CHO-K1 cell line using an innovative controlled rate liquid nitrogen freezer (RoSS.LN2F). The mammalian cells were fil...
The development and manufacturing of monoclonal antibodies represent fundamental processes in the production of several biologics, and require dedicated solutions to be carried out. As it is a highly complex procedure where much can go wrong, labo...
Handling monoclonal antibodies safely can be quite a challenge for biopharmaceutical manufacturers. mAb production is a sensitive process, prone to contamination risks that can easily lead to product alterations and product loss.1 To protect staff...
Monoclonal antibodies have kickstarted a new era in diagnostics, therapy, and research and continue to show great potential for use in medicine and science. In this article, we explore the steps that collectively lead to the creation of these b...
There are several challenges to overcome in order to make monoclonal antibody production a success. However, biopharma companies have to be prepared to face them all, as mAbs are an extremely requested product and heavily used in biotechnology: Se...
Monoclonal antibodies (mAbs) stand at the forefront of revolutionary medical advancements, playing an important role in diverse therapies and biopharmaceutical breakthroughs. The significance of these engineered proteins extends beyond traditio...
The growing request for monoclonal antibodies in scientific research and clinical applications also results in the need for professional aseptic filling solutions for mAb manufacturing. Be it in cancer therapy or the treatment of autoimmune dis...
Speed to market, flexibility, and process efficiency are more important than ever in biopharmaceutical production. Single-use systems support novel approaches to aseptic fluid management and aseptic liquid transfer. However, regarding the sustaina...
