Liquid Dose Featured Articles
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Why It Is Never Too Early To Consider Tungsten Interactions
3/2/2023
A key challenge to sensitive biotechnological or biologic drugs, especially proteins, is the potential presence of tungsten and tungsten oxides from the syringe forming process.
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New EU Directive Marks Cybersecurity Regulatory Paradigm Shift For Bio/Pharma & Medical Devices
2/15/2023
The EU's new Directive 2022/2555 on the Security of Network and Information Systems (“NIS2”) mandates cybersecurity risk management measures and reporting requirements for all segments of our industry, including labs; CROs and CDMOs; and manufacturers of APIs, bio/pharmaceuticals, and medical devices.
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Engineering Advances In Needle Geometry To Accommodate Viscous Biologics
2/1/2023
Explore the challenges faced in administering highly viscous biologics to patients via subcutaneous injection and how new special thin-wall needles are able to tackle them.
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EMA's Revised GMP Annex 1 Addresses Common Global Challenges For Sterile Products
1/18/2023
The new EMA GMP Annex 1, “Manufacture of Sterile Medicinal Products," is in line with other international regulations, e.g., ICH and PIC/S. FDA involvement in its writing is a clear indication that the contents will be the FDA position in general terms. Fortunately, the annex contains many checklists to help you assess and remedy your systems.
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ICH Final Q13 Guideline For Continuous Manufacturing: What It Means
12/16/2022
The International Council for Harmonisation released the final draft of its Q13 guideline for continuous manufacturing. It's yet another signal that global regulators see tremendous potential in CM. Here are the key takeaways.
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Cleanroom Gowning Programs Compliant With EU GMP Annex 1
12/15/2022
Part 1 of this article series provided an overview of cleanroom gowning per the revised EU GMP Annex 1. This article focuses on establishing an aseptic personnel gowning program compliant with the Annex.
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4 Key Takeaways For Combination Products As We Move Into 2023
12/13/2022
The AFDO/RAPS Combination Product Summit brought together industry leaders along with representatives of the FDA's Office of Combination Products. Of the four key takeaways covered in this article, one of them is an update on upcoming FDA guidances on this segment of the industry.
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Vaccines: An Overview Of This Life Saving Innovation
12/1/2022
Pharmaceutical manufacturing is highly regulated. Learn about what a vaccine is, how it works, the approval process, and how some vaccines can be fast-tracked through the entire process.
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Vaccines: Cleaning Regulations For Production
12/1/2022
Learn about the critical cleaning and disinfection steps as well as the associated regulations manufacturers follow in their facilities to ensure product safety and the highest standards of product quality.
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Pharma Process Validation: Initial Conclusions Are Often Deceptive
9/26/2022
As a pharmaceutical consultant, this author has observed many pharma process validation outcomes. In this article, he provides insights into two recent process validation problems that could have been avoided with an enhanced developmental approach and a greater understanding of the impact of CMAs and CPPs.