Outsourced Pharma Editorial
-
Nothing To See Here! Just Big Pharma Investments In China
4/22/2024
WuXi AppTec assists U.S.-based biotechs to develop and supply drugs to U.S. patients. Western-based Pharma assists the development of China's industry, the China Communist Party (CCP) by extension, and patients there. Guess which is under assault? Chief Editor Louis Garguilo tries to figure it all out.
-
GMP Plant Uniform Lockers And Procedures: Best Practices
4/22/2024
As the use of GMP plant uniforms has gained acceptance, locker room layouts have arisen across companies and sites. This article examines alternatives and optimized approaches.
-
A Deeper Look At What's Driving Dependence On Biotech Contract Manufacturers
4/19/2024
Are you struggling to find CDMO capacity? Here are some of the drivers behind the contract manufacturing market's exponential growth.
-
Developing A Process Performance Qualification Master Plan For Gene Therapies
4/19/2024
This article provides considerations and a framework for a Process Performance Qualification Master Plan in the gene therapy industry. It is useful for sponsors with any level of experience.
-
CDMOs Pelted By Slings And Arrows
4/18/2024
Chief Editor Louis Garguilo thought he was precipitating a frontal assault by canvassing the Outsourced Pharma Editorial Advisory Board with questions such as: When outsourcing development and manufacturing, what are the challenges, and where are your pain points? But before anyone claims “one-sided,” please read on.
-
The EU’s Ban On TiO2 In Food May Impact Pharma. Here’s What You Should Know.
4/18/2024
Titanium dioxide (TiO2) is used as a food additive and OSD pharmaceutical excipient. In 2020, the European Food Safety Authority noted data gaps regarding particle size, which can affect its toxicological properties, so the European Commission banned it as a food additive. Here's how this could impact pharma.
-
What Time Is Best To Bring My CDMO On Board?
4/17/2024
The answer might be sooner than you think and entail more transparency than you're used to.
-
Cell & Gene Therapies: An Overview Of FDA Regulatory Considerations For 2024
4/17/2024
This article outlines key FDA regulatory developments from the past few months relevant to sponsors seeking approval of cell and gene therapies in the U.S.
-
Michigan No Longer A Safe Haven For Pharmaceutical Companies?
4/17/2024
A recent change to Michigan's product liability law could have national implications. Experts at Sidley Austin detail the changes in Michigan, and explain what it could mean for pharmaceutical companies marketing products in Michigan and beyond.
-
Innovating Bioequivalence: A Novel Approach To Developing Complex Generic Dosage Forms
4/16/2024
Achieving bioequivalence for complex generics is an intricate task. This article describes an approach using in vitro–in vivo correlation, PBMK modeling, and more.