The development process for biosimilars involves an extensive testing period in order to establish similarity to the reference biologic. To ensure that the drug doesn’t have unwanted side effects, there is a broad regulatory framework developers o...
Active Pharmaceutical Ingredients (APIs) are the backbone of pharmaceutical formulations, serving as the primary component responsible for the therapeutic effects of medications. However, many APIs are sensitive to environmental factors such as...
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...
Antibody storage stands as a linchpin in safeguarding their quality: It is to ensure the cold chain across scientific research and diagnostics as well as the efficacy and safety of their clinical applications. The integrity of these essential prot...
The monoclonal antibody production process is the igniting spark in the manufacturing of countless biologics. These specialized agents have reshaped treatment methodologies, diagnostic possibilities, and research approaches. However, producing mon...
Scaling up monoclonal antibody (mAb) production is the pressing challenge faced by many in biopharma today. The need to meet the surging demand for these crucial therapies drives an urgent search for practical, effective solutions. In this arti...
