EDITOR'S DESK

  • IP & Patent Protection At The Perilous Pace Of Biopharma

    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.

Gene Therapy Development Crosses A Digital Divide

Mainframe to digital: NeuBase Therapeutics Chairman, CEO, & Founder Dietrich A. Stephan, Ph.D. says we’ve reached a digitally-enabled inflection point in disease therapy development, and that we're making rapid progress aided by big data and machine learning.

Does RNAi Have A Future Beyond Liver Disease?

On the heels of his company's RNA interference IP buying spree, Arrowhead Pharmaceuticals CEO Dr. Christopher Anzalone seeks to prove the merits of RNAi in diseases beyond the liver.

So You Want To Be A Chief Medical Officer?

BioProcess Online caught up with Dr. Loretta Itri, veteran CMO at Immunomedics, fresh on the heels of her 18th drug approval. The ensuing conversation on her mastery of the multifaceted role serves as a blueprint for aspiring chief medical officers.

The Organizational Nuance Of An Immuno-Oncology Startup

How Jeff Wolf pieced Heat Biologics together before immuno-oncology was en vogue, and how the foundation he built is supporting the company’s growth today.

GUEST COLUMNISTS

  • Hazmat Regulations: What Life Sciences Companies Need To Know

    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.

  • Can We Eradicate Tech Transfer And Other 20th Century Pharma Manufacturing Practices?

    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.

  • Operationalizing Cell & Gene Therapy: Challenges And Solutions

    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.

  • How To Generate The Right Input Data For An Effective Quality Management Review System

    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.

  • FDA Releases Guidance On Normal GMP Operations During COVID-19

    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.

  • Closing The Perception-Vs.-Reality Gap In CGMP Quality Culture And Compliance

    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.

  • Unpacking FDA’s New Guidance On Controlling Nitrosamine Impurities In Drugs

    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."

  • One-Stop Shop Or Best of Breed? 3 CDMO Selection Case Studies

    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.

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One of the most important decisions you'll face in the early stages of your biopharma journey is whether or not to entrust a CDMO with the development of your molecule. We've aggregated a collection of recent articles on the topic—all of them authored by veteran independent consultants and biopharma leaders—to offer you sound advice and insight. From ensuring a corporate culture match to writing a bullet-proof contract to meshing quality data systems, this ebook is required reading for new and emerging biopharma companies considering a CDMO relationship.

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