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...
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...
Monoclonal antibodies are specialized proteins generated in laboratories, revolutionizing healthcare treatments. They target specific cells or pathogens, offering precise therapies for conditions like cancer and infectious diseases. In this articl...
Monoclonal antibody production is shaped by changing trends and continuous scientific progress. The increasing need for high-quality mAbs for more and more applications require manufacturers to permanently improve production processes. However, it...
Aseptic filling represents a fundamental process within pharmaceutical manufacturing, serving to preserve the potency and safety of biologics throughout the production process. With stringent standards issued by regulatory authorities like the FDA...
Aseptic filling machines stand as the cornerstone in the filling of drug substance, ensuring the impeccable handling and packaging of delicate drug substances. These machines aren't just assembly line fixtures; they're the heartbeat of pharmaceuti...
Aseptic filling, a critical process in pharmaceutical manufacturing, ensures the sterility of large-volume drug substances, safeguarding their efficacy and safety. Thus, this method plays an indispensable role in maintaining product integrity. In ...
As the demand for mRNA vaccines and therapeutics increases, the biotech industry needs solutions that enhance scalability and productivity. Single-use technology has emerged as a game-changer in this regard, making mRNA manufacturing more efficien...
Monoclonal antibodies: Improved quality and better results thanks to controlled freezing and thawing In a field as sensitive as biopharmaceutical development and production, controlled processes and procedures have always played a vital role an...
Before it even comes to vaccine manufacturing, the vaccine must first be developed. The obstacles are manifold and the fragility of supply chains or requirements in cold chain management are just two of the challenges in vaccine development. Al...
Advanced cell and gene therapies, such as autologous therapies, exhibit certain specific requirements. The scale of such therapies is very different from what we typically see in conventional biopharmaceutical manufacturing processes in commercial...
At the beginning of drug discovery you always deal with small volumes. Handling the cooling of drug substances in small quantities may seem straightforward, yet the intricacies involved are often more complex than anticipated. Traditionally, the u...
AAV production has become increasingly significant over the past ten years: The Adeno-associated virus vector-based gene therapy is currently the only in-vivo gene therapy approved in the US and Europe. With adeno-associated virus being a popular ...
