Liquid Dose Featured Articles
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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.
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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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The Environmental Impact Of Biopharma Continuous Manufacturing: Part II
8/22/2022
Part 1 of this two-part series began to compare the environmental impact of biopharma continuous manufacturing with batch manufacturing. In this article, the author considers process efficiency, single-use technology, and facilities requirements.
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The Process Map To Ensure Biopharma Raw Materials Supply
8/16/2022
In new product introduction, there is often a lack of a basic data package for a product being scaled up for clinical or launch supplies. This can lead to several issues, e.g., capacity and lead time restrictions, oversupply, and more. A stepwise process can be used as a guideline for introducing a material to support new drug substance manufacture.
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Liposome Vs. Lipid Nanoparticle: What's The Difference?
8/10/2022
Here, we discuss the differences between nanoparticles and liposomes along with their applications in medicine.
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How To Navigate Drug Repurposing And Bridging Studies
6/17/2022
Rarely is a new drug the optimal version of that product, and drug companies often search for new uses, new users, or new dosage forms of an approved product after it hits the market in what is commonly known as “drug repurposing.” To receive FDA approval for a repurposed drug, companies must submit bridging studies that often include clinical trials.
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2022 Outsourcing Trends In Biopharmaceutical Manufacturing
6/15/2022
The continued focus on productivity and efficiency is moving manufacturers to increasingly consider outsourcing activities. Biomanufacturers are spending more, demanding better technologies, and expressing greater optimism. This article shares the trends in outsourced activities, percentages of activities outsourced, outsourcing destinations, and offshoring.