Jill Wechsler is BioPharm International's Washington editor.
Attendees at the Bio-Process Systems Alliance annual summit discuss the benefits of single-use technology in biopharmaceutical manufacturing.
FDA seeks high quality applications and products to facilitate approvals and reduce safety and supply problems.
Stakeholders face challenges and benefits from a more secure pharmaceutical supply chain.
Supplier Audit Program Marks Progress
Regulators and industry organizations explain policies and standards to manufacturers and authorities in all regions.
New formulations and expanded vaccine production are encouraged.
New identifiers and tracking requirements aim to block illegitimate products.
Accelerated testing and production create challenges in documenting product quality.
FDA plans to issue a number of new guidances in 2014 that will address drug development and manufacturing practices.