For companies that decide to outsource high-potency active pharmaceutical ingredients (HPAPI) manufacturing, it is critically important to understand what goes into the process of manufacturing highly potent compounds. This article outlines some of the key considerations for HPAPI manufacturing and CDMO selection.
This article emphasizes the importance of implementing a regular routine maintenance schedule for inductively coupled plasma mass spectrometry (ICP-MS) equipment, so problem areas associated with instrumental components that are most susceptible to sample blockage, drift, and signal instability can be avoided.
Testing for evidence of microbial contamination in bioprocessing has a long history — and can be expensive, slow, and burdensome. So suppliers, testing facilities, and regulators have been seeking improvements.
Looking forward, the U.S. pharmaceutical industry needs to be aware that despite the FDA’s year-long delay in enforcement, the Drug Supply Chain Security Act (DSCSA, with its specific compliance deadlines, is still law and that it is only draft guidance from the FDA that identifies an intent not to enforce the DSCSA for one year.
A busy practicing physician who might be asked by a friend or a patient for a first-impression opinion of the currently pending federal Right to Try legislation will find him/herself in a position roughly analogous to the hungry child being offered candy by a stranger: viscerally tempted, but intellectually very, very wary.
Due to globalization, restructuring of organizations, and the emergence of fast-paced technologies, companies need to endorse efficient and effective methods of performing validation. This is especially true when establishing a defendable environmental sampling plan (performance qualification phase), since there is a higher probability for the FDA or other regulatory agencies to scrutinize the documentation process during inspection when companies attempt to obtain licensure of their facility for the manufacture of their products1.
Many organizations with very robust QMSs routinely find themselves in a state of disarray and facing compliance issues when key members of the quality leadership team leave the organization.
Ever participated on one of those benchmarking exercises? You know what I mean: a (usually) fresh-faced consultant asks lots of questions and fills in a spreadsheet comparing what you do with your competitors. Well, beware.
Drug developers have found a powerful ally in their campaign to advance biosimilar adoption in the U.S. — the nation’s health insurance providers. Insurers are keen to drive down the price of reference biologics, and they view biosimilars as an important way to accomplish that goal.