Industry Insights
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Prefilled Syringes: Best Practices For Using X-Ray Analysis To Assess Container Closure Integrity
8/18/2021
The process of assessing integrity of the filled syringe is generally more complex than the process of assessing glass vials due to the presence of more sealing areas. This article looks at the broad requirement, together with a recent innovation for integrity testing based on X-rays.
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Are You Ready For The FDA’s “Data Effect” Tsunami? 8 Steps To Prepare
5/5/2021
The FDA is moving forward with its Data Modernization Action Plan, the next leg of the Technology Modernization Action Plan. As such, you'll need to prepare yourself for the influx of questions, audits, observations, warning letters, and more. Here's what you can do to position yourself for success.
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A Six-Step Process To Assess Risk And Benefit In ICH Q9 Decision Making
7/23/2018
Identifying the best risk control options can be a challenging process without the ability to view all the information needed for the investment.
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Rare Diseases: How To Leverage Social Media For Patient Analysis
7/15/2021
Due to insufficient sample sizes and a lack of granularity, traditional data analysis of rare diseases produces unreliable results. What can you do to learn more about patients with rare diseases? Leverage data from social media and other online sources! The internet offers a trove of public data waiting to be tapped into.
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The Future Of Regenerative Medicine: A Macro View On Emerging Applications
10/27/2020
Part three of a three-part series on the future of regenerative medicine explores how regenerative medicine will help to improve quality of life in line with continued rise in global average life expectancy.
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How To Pick The Right CDMO For Late-Phase Clinical Trials
This article examines some of the key criteria for selecting the right CDMO partner and includes a case study that shares some challenges involved in a late-phase technology transfer for a parenteral product.
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Continuous Manufacturing: Many Want It, But Here’s Why Few Have It
2/13/2024
In 2023, biomanufacturers showed an increasing interest in continuous manufacturing, but uptake, believe it or not, slowed down. Let’s explore the reasons why with data from BioPlan Associates.
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Do You Make These 3 Mistakes In Your CDMO Contract Negotiations?
4/7/2017
Potential partners often take positions during a contract negotiation that at best delay the project, and at worst, scuttle the partnership. Here are three examples of short-term thinking that are common in both the customer and contractor sides of the negotiation.
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A CTO’s Journey Into Continuous Biomanufacturing
8/24/2022
At a recent Evaluating BioPharma virtual event, moderator John Bonham-Carter asked Chris Hwang, chief technology officer at Transcenta Holding Ltd., about Chris’ journey and experiences with continuous bioprocessing thus far in his career.
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Single-Use Technologies: A Game Changer For Expanding mAb Production
3/4/2022
A biotech company that this author worked with had an expanding pipeline and needed to increase its manufacturing capacity, so single-use technologies were implemented from media prep through buff prep, to seed train and through the downstream process. The company saw a dramatic reduction of production costs.