Search results for " efficacy"
Article
Manufacturers Struggle with Breakthrough Drug Development
Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), is excited about the emergence of many new drugs “with incredible efficacy for certain subgroups,” but acknowledged that…
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
The QTPP provides the basis of the desired quality characteristics of the drug product, taking into account safety and efficacy (i.e., purity, identity, strength, and quality). The QTPP should not be …
Article
Essentials in Quality Risk Management
… method, and associated process changes are understood and managed to ensure patient safety and drug efficacy. An effective QRM process can further ensure the high quality of the drug product to the …
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
…ngent impurity level targets than exist now because the technology is more mature and the safety and efficacy is well established. For example, early mAbs had levels of high molecular weight species …
Article
Introducing the VH3 ligand ELISA kit
Ensuring the safety and efficacy of antibody-based therapeutics is crucial in biotherapeutic manufacturing. Accurate testing for ligand leakage from affinity resins is a key part of this proce…
Article
Moving Biosimilars Forward in a Hesitant Market
The biosimilars landscape is growing as market factors, such as pricing pressure, advanced bioprocessing and analytical technologies, and upcoming patent expirations for innovator biologics dr…
Article
Right the First Time: Bioreactor Scale and Design Translation
Cell culture process transfer requires a good understanding of the physicochemical conditions within a bioreactor. This includes the hydrodynamic environment induced by the agitator and the …
Article
Getting your investigational drug regulatory ready
From the submission of an investigational new drug (IND) application, regulators will want to see a purposeful plan to assess drug safety, quality, and efficacy over time. In this article, we outline …
Article
Expanding the Emerging Therapeutic Horizon
Despite the successes that have already been achieved with emerging therapy development and manufacturing, companies are still facing numerous challenges. Aspects such as demand for accelerate…
Article
What’s in your media? How costly is variability of cell culture media to your manufacturing process?
When we discuss the sources of variability in cell culture media— it indicates that our customers are making a product and viewing fluctuations in efficacy or glycosylation pattern. It is important to…