Fabs, or fragments of antibodies with antigen binding, offer advantages over monoclonal antibodies Several (mAbs) including binding to epitopes unattainable, tissue and tumor penetration, and Improved manufacturability.
Enabling Higher Post Protein A Novel Product Purity Using Chromatographic Clarification Approach (La Vague 49)
Antibody based therapeutics account for 40% of the Entire biotech drug market. In 2012 alone, the total generation antibody drug exceeded $ 50 Billion in sales value (1).Monoclonal antibodies are Becoming The leading driver of the therapeutic product pipeline. Together with the Increased number of drug candidates comes the challenge of adequate Ensuring That year, low cost, safe, and scalable manufacturing capacity exists and is reliable to address the ever Increasing complexity of These bio-therapeutics.
Practical Guide Rationalization of periodic qualifications of autoclaves, depyrogenation tunnels and vial washing machines for injectable formulations (La Vague 48)
This article is a summary of the workshop offered during the 2014 A3P Congress in Biarritz.
It is a regulatory expectation that equipment used for injectable formulations, autoclaves, vial washing machines and depyrogenation tunnels should be subject to periodic qualification. Through this practical guide, we provide information about the regulatory context associated with these activities, as well as qualification expectations for these three types of equipment.
The detection of mycoplasmas by qPCR: the challenges of installing this test as a replacement for the regulatory culture method described in different pharmacopoeias (USP, EP, JP…) (La Vague 49)
The contamination of cell cultures by mycoplasmas represents a major risk for the biopharmaceutical industry. Owing to their diversity, their small size, and the absence of a bacterial wall, these microorganisms cannot be detected by microscopy, are very difficult to eradicate and can compromise the quality of medicines.
For some years now, certain words have resounded regularly in our ears, including “LEAN”, continuous improvement and innovation...The reassurance to be found in the option of “continuing in the same way as before” means that these words are not always uttered without fear. It is admittedly more “comfortable” not to “change” too much and to advocate a certain “conservatism”.