Industry Insights
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MHRA’s Compliance Report
3/26/2013
On February 5, 2013, the MHRA put out an update bulletin on its “Compliance Report”. The Compliance Report from the MHRA began around 2009 when they moved to a risk based pharmacovigilance (PV) inspection process. By Bart Cobert
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Sex Matters… In Preclinical Drug Development?
1/18/2022
In safety pharmacology studies investigating short-term side effects on physiological functions, the scientist is obliged to “consider” sex in the study design of animal models. This article also shares the differences in anxiety and depression in human males and females.
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Is Your Facility Aging? How Can You Tell And What Should You Do?
6/22/2018
"Aging facilities" is a trendy catchphrase that has taken hold in the biopharmaceutical industry in the past few years. While most of us might think we understand intuitively what the words mean, perhaps we don’t.
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Less Than A Year Until EU MDR: Are All Your “Economic Operators” Compliant?
8/20/2020
Although the new requirements relating to economic operators under the EU MDR may still raise questions for manufacturers, the recent delay of the date of application by one year will give the industry additional time to get their regulatory matters in order.
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5 Tips For Orphan Drug Development In A Price-Sensitive Payer Environment
7/7/2017
Despite the complex maze of challenges developers must navigate to create a commercially successful orphan drug, there remains a lucrative path forward for developers committed to bringing novel, effective therapies to market.
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A Functional History Of Process Validation, Part 1 – A Weak Foundation
8/7/2020
This article is the first of a two-part series that describes the origins of process validation to explain the underlying concepts necessary to control the advanced bioprocess manufacturing technologies required to make the next generations of biopharmaceutical therapies.
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Cell & Gene Therapy Bioprocessing: Demand For Better Process Control, Expertise & CMOs
5/14/2021
Manufacturing capacity for both cell therapies and gene therapy viral vectors remains in short supply. From BioPlan Associates, Inc.'s new survey of biopharmaceutical manufacturing professionals, there is a current and worsening capacity crunch. The industry continues to demand innovative solutions from its suppliers in key areas that can be slow to develop.
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Analyzing The Process For Single-Use Prokaryotic Cell Cultivation
2/29/2024
Aseptic risk management plays a crucial role in bioproduct safety and efficacy. Discover a process for single-use production and automation control logic that ensures stable and efficient production.
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Fixing The Follow-On Insulin Regulatory Approval “Dead Zone”
9/4/2019
With all the attention on the costs of pharmaceutical products, there is an upcoming regulatory “dead zone” that will potentially delay market entry of certain insulin products, adversely impacting insulin prices for consumers and payors. A recent Senate bill has been proposed to address this regulatory anomaly. Industry players should monitor this bill and other efforts to address the insulin dead zone, given how critical this product is to so many people.
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An Introduction Process Analytical Technology
6/21/2017
The routine use of PAT in an integrated manner to design, measure, and control critical process quality and performance attributes through timely and appropriate measurements remains largely unrealized across the pharmaceutical industry.