Industry Insights
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The Promise Of Augmented Reality In Cell Therapy Manufacturing
5/18/2023
Augmented reality enables drug sponsors to provide remote assistance and direction to their manufacturing team during tech transfer, reducing costs, streamlining timelines, and improving the effectiveness of manufacturing processes.
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How Will Medicare’s International Pricing Index Model Affect Biosimilars?
12/18/2018
CMS has announced a new payment model that seeks to reduce out-of-pocket costs for patients. This payment model arises out of the Trump administration’s American Patients First Blueprint that was released earlier this spring. CMS is providing this notice of its proposed payment model via an Advance Notice of Proposed Rulemaking (ANPRM), meaning a formal proposed rule will be introduced in the near future. Comments close on this ANPRM on Dec. 31, 2018.
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Identifying Outliers In Process Data Using Visual And Analytical Techniques
1/12/2018
Properly identifying outliers can assist companies with the proper establishment of trending and excursion limits for complaint and nonconformance management and other aspects, which can trigger investigations or initiate the formal CAPA process.
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Navigating DSCSA Implementation: Key Requirements & 4 New FDA Guidances
7/5/2021
In the U.S., you're grappling with how to set up a fully interoperable electronic system for securing and tracing products across industry sectors per the Drug Supply Chain Security Act (DSCSA) by Nov. 2023. Here's how to navigate the key requirements, as well as the FDA's four new guidances on the subject released in June.
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What Will The USMCA Mean For MedTech?
1/29/2020
Analysts appear to agree that the USMCA represents an upgrade — albeit a modest one — over NAFTA for all parties included. This article has been updated with developments through January 2020.
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What To Do When Your CMO Has To Transfer Your Product To A New Facility
8/8/2017
You just received an official notification from your CMO: It is going to remediate the facility in which you have been making a commercial product for six years. Now, you look at your options. You can stay with your current CMO, or you can take this opportunity — forced though it may be — to determine if it is time for a change.
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Reduce Costly Scale-Up Problems
4/11/2024
Scaling a new drug formulation from development to manufacturing often presents challenges, but there are ways to minimize deviations and streamline your transition.
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Assessing The Impact Of New Equipment On Your CDMO’s GMP Operations
12/18/2018
To a drug sponsor, a CDMO’s new equipment could mean production may be able to start sooner than expected, or it might allow them to continue working with a CDMO rather than switching to another.
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Beware of Underestimating The Value Of A Pre-NDA Meeting
11/19/2020
This blog covers the benefits and how to prepare for a pre-FDA meeting, what should be in your pre-NDA briefing package, potential topics for discussion as well as who should attend the pre-NDA meeting.
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4 Steps Toward End-To-End Connected Manufacturing
7/25/2019
Breaking down the implementation of continuous manufacturing into the following four steps may provide some much-needed guidance as you prepare your network for the future of biomanufacturing.