Current market conditions such as regulations and mergers or acquisitions make improving compliance and manufacturing efficiency while driving to grow revenue and margins difficult.
CMOs can empower their sponsors or customers to conduct many of these activities on their own products or processes through better data transparency.
In May 2013 the U.S. Food and Drug Administration (FDA) released its draft guidance, “Contract Manufacturing Arrangement for Drugs: Quality Agreements,” with recommendations representing its “current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (CGMP). In particular, we describe how parties involved in the contract manufacturing of drugs can utilize Quality Agreements to delineate their responsibilities and assure drug quality, safety, and efficacy.”
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?
This BIOVIA customer uniquely combines the reach and resources of a major pharmaceutical company with the entrepreneurial spirit and agility associated with the world of biotech. The company focuses on a range of illnesses including cancer, cardiovascular disease, diabetes, hepatitis B, HIV/ AIDS, rheumatoid arthritis and psychiatric disorders. Their R&D organization prioritizes pipeline velocity and sales growth while continuing to manage costs.
Analytical laboratories have to provide sound results in a short time. Speed and reproducibility play a significant role here. Modern automation technology saves time, increases quality and reduces costs.
This article takes an in-depth look at how lipid-based drug delivery systems can be used as a bioavailability enhancing technology, as well as the softgel dosage form for their delivery.
Formulation techniques and technologies can easily become more habit than science, but a single technology does not work for all compounds. Each new drug is unique and deserves a fresh approach to formulation.
Targeted Oncology™, a print and digital resource that offers content and expert opinions on precision medicine in oncology, will launch the first Expert Perspective: Virtual Tumor Board on April 24