Industry Insights
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Ensuring A Successful Technology Transfer
Manufacturing at scale requires adherence to established, scale-dependent process parameters and close examination of product characteristics and quality attributes. Learn the key considerations when preparing to move products from small-scale to large-scale production.
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505(b)(2) CMC Basics: Aligning Chemistry, Manufacturing, And Controls With Clinical Trial Phases
8/8/2022
While the successful completion of clinical trials can invite and maintain funding, those trials are not meaningful without an appropriately designed, manufactured, and controlled drug product.
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The Critical Role Of Residue Removal In Cleanroom Biosafety Cabinets
3/28/2024
Learn about the significance of residue removal, how it is effectively performed in cleanrooms to ensure the compliance of biosafety cabinets, and the impact of proper residue removal.
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Defining Holistic Asset Criticality To Manage Risk In Biopharma
This article presents how risks to safety, quality and productivity can be managed through asset control strategies, which are created based on specific asset criticality and failure modes.
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Combination Device Regulatory Strategy: Success With The FDA
10/28/2021
Breakthrough combination products frequently emerge that provide patients with therapeutics comprised of two or more constituents. Read how having an adaptive regulatory strategy is key.
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3 Steps To Achieve Total Quality Management In Pharma Manufacturing
2/17/2023
How can your company capitalize on the latest quality management trends by adding Total Quality Management tools to their toolboxes?
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3D Printing In The Pharmaceutical Industry: Where Does It Currently Stand?
12/21/2018
In 2015, Aprecia Pharmaceuticals produced the first tablet manufactured through 3D printing to be approved by the FDA. Now, with applications in controlled release, short-run medicines, and even the potential for on-site printing at pharmacies, 3D printing technology has the ability to transform the pharmaceutical industry.
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Super Generics: Market Trends In Europe
3/12/2024
Super generics combine advanced formulations and delivery methods, and improved bioavailability, compared to traditional generics. This article shares market research trends in the market in Europe.
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Making FMEA More Robust With HACCP
8/27/2020
Risk priority number scores and criticality analysis are frequently used to quantify risks for users, designs, and processes. However, these traditional failure mode and effects analysis (FMEA) techniques often fail to fully document risks associated with contamination. To complement FMEA, consider borrowing a risk-management technique from the food industry.
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A Smart, Data-Driven Approach To Formulate Biotherapeutics For PFS
3/5/2024
Explore a unique model to predict injection force designed to decorrelate factors linked to formulation development and the ones linked to container and delivery device selection.