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Making the Grade: The Importance of Using the Correct Excipient Grade in Drug Products
With an ever-growing market driving technological advances, there is always work to be done in drug manufacturing.
Advanced oral dosage forms allow for modulation of controlled- and sustained-release profiles.
Packaging and packaging line innovations are addressing the industry’s growing use of biologics.
What are the lessons gleaned from a product’s E&L lifetime?
There are considerations companies may want to consider before seeking out a service provider.
The Biosimilars Landscape
May 04, 2024
A new draft guidance issued by FDA covers human- and animal-derived materials used in the manufacture of advanced therapy medicinal products.
May 03, 2024
Cormica’s first US Acquisition is intended to support to organic growth of TPM laboratories.
The loan is intended to support Ennogen’s growth as it looks to international acquisitions.
In this exclusive Drug Digest video interview, Chris Spivey, Director, Industry Relations and Strategic Partnerships, talks with industry experts about various aspects of drug product stability testing.
Technological advances are helping advance biologics development and manufacturing and reduce bottlenecks.
May 02, 2024
The report covers the major achievements of the office during 2023, including notable drug approvals, publications, guidances, workshops, webinars, and meetings.
Guidance documents and interaction with FDA can help manufacturers stay in GMP compliance, says Siegfried Schmitt, VP Technical, at Parexel.
In the new draft guidance, FDA provides recommendations on cell safety testing of human-sourced allogeneic cells for sponsor companies.
May 01, 2024
The CDMO plans to expand and upgrade its Philadelphia, Ohio, and Milan facilities to meet the continued growth in demand for high potency handling capabilities.
Josh Hirshenhorn (Sales Representative, Rees Scientific) explains current challenges faced by pharmaceutical and biotech companies and how Rees' continuous monitoring systems offer solutions.