Companies must understand how today’s new pharmaceutical landscape is causing a dramatic shift in how we plan for and execute drug development and manufacturing.
In as little as 14 weeks from receiving your small molecule API, you can have your Phase I drug product manufactured, labelled, packaged and delivered to the clinic. That’s 1 month faster than most standard timelines, and includes a one-month stability study.
Follow the paths of two companies as they learn how a science-led, risk-based development approach yields a more successful outcome in the long run.
Whether your goal is to increase patient compliance, improve clinical outcomes, or to extend a product’s lifecycle, modified-release dosage forms present a solution to myriad challenges.
Pharmaceutical suppliers are tasked with responding to ever-evolving changes in regulatory requirements, which impact everything within an organization—from operations to the way trials are conducted.
Today’s biologics pipeline is healthy, but near-term forecasts indicate growth so robust, the industry risks being ill-equipped to meet demand. Can biopharma count on contract manufacturers to rise to the demand challenge?
A majority of pharmaceutical gels are shear-thinning semisolids prepared by dispersing hydrophilic polymers into an aqueous vehicle. Proper mixing requires a good balance between agitation and shear.
To keep the risks in bioproduction as low as possible, an increase in calibration frequency is required. Read how the self-calibrating iTHERM TrustSens temperature sensor kept downtime to a minimum.
While traditional small molecule drug products usually consist of pure chemical substances that are easily analyzed after manufacture, biologics such as monoclonal antibodies (mAbs) are much more complex.
Choosing the right contract organization to handle the development and manufacturing of a drug product is of critical importance. Here are tips to ensure a successful outcome.
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