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Transferring Energy to Hot Melt Extrusion
A greater understanding of molecular and cellular biology and technological advancements are revolutionizing the field of biologics.
The use of appropriate taste-masking and appearance technologies can facilitate patient compliance.
A comparison between polysorbates and HPβCD determines the better stabilizer for biologics formulation.
This study reviews changes in in-country testing (registration testing, import testing) requirements and analyzes current trends.
Guidance documents and interaction with FDA can help manufacturers stay in GMP compliance, says Siegfried Schmitt, VP Technical, at Parexel.
A Closer Look at mRNA in Oncology and Vaccines
May 11, 2024
Regeneron's Sven Moller-Tank, PhD, director of Viral Delivery Technologies, Regeneron Genetic Medicines, discusses the company's work in using bispecific antibodies for redirecting AAV target specificity.
May 10, 2024
At CPHI NA, Rachel Harris, AstraZeneca, spoke on her work at BioPhorum to enable industry consensus and action for sustainability with drug delivery devices.
May 09, 2024
Tara Dougal, content director, Pharma, Informa Markets, discusses successes and insights from this year’s CPHI North America and the agenda for the upcoming CPHI Milan.
Purna Thakker, founder and CEO of ADPT Solution, discusses common issues that companies face with FDA regulations at CPHI North America.
The company’s presentation at ASGCT includes preliminary data results for a child who received the gene therapy.
May 08, 2024
Experiments conducted by the downstream technology team at Spark Therapeutics involving metal ion-containing additives showed improved capsid clearance in AAV production.
The company is presenting preclinical data at the American Society of Gene & Cell Therapy annual meeting that supports the potential of the company’s CAP-002 gene therapy for correcting neurological phenotypes associated with genetic epilepsy due to syntaxin-binding protein 1 (STXBP1) mutations.
This study reviews changes in in-country testing (registration testing, import testing) requirements and analyzes current trends. In the context of international harmonization of good practices and standards as well as the improved information exchange between national regulatory authorities, in-country testing is considered outdated and redundant in many cases.
May 07, 2024
ProPharm and PBL have introduced a fully automated, enclosed cell factory manufacturing device.