Industry Insights
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How To Reduce Change Orders In Your Product's Tech Transfer
10/25/2021
After conducting the legwork of determining the best fit for a CDMO from capabilities and organizational fit perspective, the next step is working with that vendor on determining costs.
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A Checklist For Risk Assessment Of Nitrosamine Impurities In Oral Solid Dose Drugs
3/12/2021
Nitrosamine impurities such as N-nitrosodimethylamine (NDMA) are being identified in high-volume drug products such as valsartan, losartan, irbesartan, and ranitidine at levels well above the acceptable daily intake limits. The credit for identifying the higher NDMA levels goes to an independent pharmacy that tests every batch it dispenses, exposing limitations in drug substance and drug product post-approval change assessment and analysis requirements at pharmaceutical manufacturing organizations.
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Incorporate Real-Time Data Sharing Into Process Development
9/11/2020
It is important to consider solutions that could help your process development experts share their observations and collaborate on how to prevent issues later during the critical ― and more expensive ― stages of manufacture.
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Method-of-Treatment Patents: Increasing Value & Risk
12/27/2021
Patents on methods-of-treatment using pharmaceuticals are being asserted in broad ways against a variety of parties, with potential liabilities of hundreds of millions of dollars. Method patents can be obtained not only for new indications but also for other discoveries made after the initial approval, like dosing regimens.
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Cats In The Warehouse! 9 Real-Life Blunders To Avoid In Your Pharma Facility
12/13/2019
Our previous review of humorous and horrifying pharmaceutical facilities blunders Pigeons In The Plant: 10 Real-Life Pharma Facility Blunders (And How To Avoid Them) revealed our industry is flawed like any other. Here are some examples from the engineering side of the business.
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Powder Characterization For Selecting Material Of Construction
2/26/2010
For powder processors material of construction or surface finish choice is an important element of design, critical to achieving the fundamental compatibility between powders and process that underpins successful long term performance. By Tim Freeman, Freeman Technology
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4 (More) Critical Considerations For Drug Delivery Device Development
8/12/2019
The majority of biologic products today are launched as some form of combination product, stringently regulated by the FDA through 21 CFR Part 4. This article looks at important manufacturing, packaging, and other factors that developers of combination products must consider and why they need to be considered early in the device development program.
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Pharmacy Compounding Vs. Manufacturing For Clinical Studies: The Regulatory Perspective
12/18/2019
FDA requirements and compendial standards for pharmacy compounding and outsourcing continue to evolve, and the FDA has different requirements for products prepared through pharmacy compounding practices as compared to those manufactured for use in clinical studies.
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Innovating Drug Dosage Forms And Supporting Patient-Centric Goals
Learn how delivering HPAPI drugs in OSD form can help boost patient compliance and consider the formulation challenges inherent to HPAPI development and manufacturing.
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Dealing With Packaging Complexity
By Stephen McIndoe, VP Consulting, Be4ward
In this series of articles, I am going to discuss the topic of packaging complexity and outline tips on approaches you can take to manage it.