Fast-tracks and breakthrough statuses are piling up at an unprecedented clip, and the President is promising the spoils of war to the first vaccine manufacturer to smash speed-to-market records (preferably prior to November 3). It's incumbent on biopharma execs—every one of them in the C-suite—to ensure protection of their intellectual property and patents.

It is important for life sciences companies to understand the regulations laid out in the U.S. Department of Transportation’s 49 CFR Parts 100-185 — and their impact on package design and testing requirements, training requirements, and packaging and handling hazardous materials in bulk and non-bulk forms.

While warp-speed manufacturing is a pandemic term, the concept is an important part of the FDA’s 21st century vision of “a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high-quality drugs without extensive oversight.” Reaching 21st century performance will require replacing many of the industry’s 20th century practices with new and innovative methods and capabilities.

Cell and gene therapy has proven to be the future of cancer treatment, however, challenges remain in getting cell therapies to the market and into routine use to be widely adopted.

This article is the second in a two-part series about demonstrating CGMP compliance during inspections by establishing a successful quality culture and related systems. Part 1 discussed the importance of “top-down” quality management and “bottom-up” communication of compliance risks and concerns. Here in Part 2, we turn our attention to the input data for an effective QMR.

Most FDA guidance on COVID has been associated with tools to combat the pandemic. This new guidance should be read by all drug and biologic manufacturers, whether or not they produce COVID-related products.

This article is the first in a two-part series on how to demonstrate a high level of current good manufacturing practice (CGMP) compliance during inspections by implementing a strong quality culture; driving the open, transparent communication of risks; and establishing effective quality risk management and quality management review.

On Sept. 2, 2020, the Federal Register announced the availability of a final FDA guidance, "Control of Nitrosamine Impurities in Human Drugs." This guidance is immediately effective and was not subject to the usual comment period “…because of the importance of providing timely information to manufacturers regarding risk assessments, testing, and other appropriate actions they should take."

Following last week’s editorial by chief editor, Louis Garguilo, Ray Sison, xCell Strategic Consulting, has prepared three case studies and a detailed analysis of the best-of-breed and one-stop-shop outsourcing models. Learn to define a strategy that best fits your product requirements and aligns with your corporate objectives.