The outsourcing market is growing rapidly due to industry trends such as increasing demand for advanced medicines to address unmet needs, global economic expansion, and the FDA’s growing use of accelerated approval pathways. Drug sponsors now have access to a larger-than-ever pool of contract service providers from which to vet a potential partner.
Due to a paradigm shift in the pharmaceutical industry, there is rising pressure to come up with faster, more cost-effective ways to produce drugs for the patients who need them.
White paper on the risks related to bioburden downstream processing and the solutions available to mitigate these risks. Topics covered include improvements in raw material quality, equipment design, chromatography resin properties, and ways of working.
It is the dead of winter in the northern hemisphere and the height of summer in the southern, with external temperature fluctuations exceeding 50 degrees. Flight delays have added precious days to the transport of your multi-million dollar shipment of blockbuster drug from South East Asia destined for Russia. In France, the roads are closed for days due to a monster snowstorm, with your irreplaceable shipment of investigational drugs stopped somewhere en route between Paris and the clinical trial site. Will all be lost, or can informed choices made before the shipment departs ensure product safety despite unforeseen circumstances?
Today’s chemical development labs are busy places that create fascinating new chemicals, new formulations and new products that boost the bottom line. But are these labs as efficient as they could be?
In 2008 Hollister did a thorough evaluation of available solutions to automate some key internal business processes including the tracking of product registrations and the management of CAPAs. Since Hollister has to track registrations for its products in many different countries, the Regulatory Affairs department needed an automated solution to track when a registration was coming due so they could submit a new packet to renew a registration. Additionally Hollister needed to upgrade its existing Corrective Actions and Preventative Actions (CAPA) management system that was built on a Lotus Notes platform that was going to be retired.
Electronic lab notebooks (ELNs) are one of the primary scientific informatics solutions for helping scientists design, execute, analyze and report on experiments—but selecting the right ELN can be a challenge.
The encapsulation of liquids and semi-solids provides solutions for convenient delivery through improved oral absorption of poorly water-soluble drugs.
You need to transport high-value, specialty or clinical trial products around the world. You know that shipment integrity is essential—that you can’t afford temperature excursions resulting from a shipment getting delayed in customs, that shipments gone awry can result in devastating losses for your organization.
Is your team ready to manufacture larger batch sizes to support if Phase III studies are on the horizon?
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