News & Analysis on Clinical Trial Services & Contract Research And Development
There are several key considerations to how companies should approach commercial-scale manufacturing that may aid the success of their biologic’s launch into European markets. In some cases, there is a need to identify a partner to support the product’s lifecycle. In this Q&A, four Catalent Biologics experts share how scale-up, regulatory expectations, demand forecasting and process validation all play a role in the success of a biologic when embarking upon the commercial manufacturing journey.
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The nature and scope of clinical research has changed significantly over the past decade. Studies are more complex, globalized and patient-centric than ever. Yet, the processes used to package and ship study drugs to trial sites are stuck in an earlier...
With clinical study activity increasing across the Asia-Pacific region, it is important for sponsors—both in APAC and globally—to understand the broader area landscape in order to develop a distribution strategy that avoids delays and minimizes cost and...
The pharmaceutical industry had to adapt quickly to the pandemic if it was to continue to supply important medicines, while also racing to develop vaccines and treatments.
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