Developed by the FDA, the Biopharmaceutics Classification System helps companies when they file for bioequivalence of dosage forms based on in vitro dissolution testing.
Fluorescent western blotting is a technique where fluorescently tagged detection antibodies help directly determine the level of protein expression. It is a method that is becoming increasingly popular due to recent advances in digital imaging technology and fluorescent western blotting reagents. Not quite sure about this technique? Read about the reasons to start fluorescent western blotting.
Bio-developers are adopting more sophisticated processes, such as perfusion, to address low titer cell lines and reduce raw material costs. They’re also seeking more flexible R&D and PD capabilities.
In recent years there have been several potentially life-saving medications approved for cancer treatment, including targeted molecular entities and biologics such as Opdivo (nivolumab) and Keytruda (pembrolizumab). Oncology drugs remain a pharmaceutical priority and investments into cancer account for 30% of all pre-clinical and phase 1 clinical development expenditures. There is an impressive list of close to 800 drugs and vaccines currently in the industry-wide development pipeline, many with promising results in early-stage clinical trials. However by historical measures only 10% or fewer of these drugs will ever make it through FDA approval and become part of routine patient care.
Seeing is believing – this is an important aspect of Tissue Phenomics, where cellular structures in tissue slides taken from patients are investigated in real space. Observing directly what type of structures form and what kind of interactions take place is in general of much higher value than concluding indirectly from other type of data. I experienced this factor very clearly thirty years ago when people speculated about the atomic structure on the surfaces of matter from indirect measurement.
As healthcare continues its transition towards precision medicine, physicians are eager to maximize both the quantity and quality of data obtained from their patients’ tissue samples. In the current “one drug, one test” paradigm, physicians struggle to balance the number of tests required to make a treatment decision with the limited amount of tissue that is available.
Electronic Lab Notebooks are a key component of an electronic lab environment that helps scientists execute faster, more informed, high-quality science. It’s a vision scientists have talked about for decades.
The reality is that paper is more of a habit than a requirement. AstraZeneca discovered this when they aimed to introduce ELNs to improve the efficiency of their validated workflows for GMP API manufacture.
The method of western blotting was first introduced almost 40 years ago. Towbin et al. (1979) presented a method that demonstrated the electrophoretic transfer of ribosomal proteins from a polyacrylamide gel to a nitrocellulose sheet and the detection of those immobilized proteins using radioactively labeled or peroxidase-conjugated antibodies. Western blotting methods have since become a widely utilized method of identifying and quantitating proteins in most life science research labs, but the basic principle has remained fundamentally the same. What has changed is how proteins are detected on a membrane.
One area coming under increased regulatory scrutiny is change control: the ability to manage deviations to established policies and procedures in a way that is efficient, timely and compliant.
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