The paper-based lab versus the digital lab. The largest barrier to innovation for any lab is performing tasks manually and recording experiment data in paper lab notebooks. Easy-to-use digital applications can increase productivity while reducing wasted time and inefficiencies associated with searching for relevant experiment data.
The diseases related to Gram-negative bacteria affect humans and animals and, in many cases, are difficult to treat, which is why is important to have effective and bacteria-specific antibiotics.
Current adventitious agent test methods feature numerous limitations. Assays based on polymerase chain reaction (PCR) offer the potential to lift these limitations and offer better overall detection of adventitious agents. This is an area that biologics manufacturers are actively exploring, and current research indicates that PCR-based testing is not only scientifically valid but also acceptable to regulators.
How to incorporate a new process into an existing facility is a basic question that begins every project. The client usually has a preconceived idea of where a new process will go and how much space is available, but if we stop here and do what we are told, preconceived notions may drive us to a point where we find that project needs haven’t been met.
The success of any biologic drug, for example, monoclonal antibodies (mAbs), recombinant proteins, or biosimilars, depends greatly on downstream purification. Among the challenges process scientists often face during this process is the formation and/or removal of aggregates of monomers.
The success of any biologic, such as monoclonal antibodies (mAbs), recombinant proteins, or biosimilars, depends greatly on downstream molecule purification. Process scientists often face multiple challenges during this process, including the formation of aggregates.
Any company pursuing a drug delivery system that involves a complex formulation must be prepared for the requirements around this type of drug development to achieve successful scale-up.
Even with forecasting and building out a sizeable buffer inventory, clinical sites may still not always have the appropriate kits on hand to dispense to patients. Why?
In the recent Economist Intelligence Unit survey on biopharma’s present and future, biopharma industry leaders expressed excitement and some uncertainty about the emerging markets of the Middle East and Africa. Respondents saw great opportunity in these regions, but also cited potential risks in relation to regulatory questions and stability issues. We spoke with Bert de Vet, Head of Commercial EMEA Process Solutions at MilliporeSigma, about his take on growth in the region and some of the ways companies entering these regions can mitigate risk.
In today’s pharmaceutical industry, the economic strains of keeping a company completely vertically integrated are no longer feasible. Smaller, virtual drug companies simply do not have the resources necessary to translate a molecule to a drug product.
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