Fill & Finish Resource Center

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Split Decisions: Tablet Scoring Under More Scrutiny
FDA provides more direction as questions arise about dosage consistency.

NIPTE, IPEC Work to Standardize Excipient Properties Database
Excipients, many of them naturally derived, are a source of variability in drug manufacturing, as differences in processing and other factors can lead to significant differences in the properties and performance of materials of the same grade, not only between different vendors but from the same vendor.

Optimizing Coating Parameters to Improve Tablet Performance by Means of Terahertz Pulsed Imaging (TPI)
Through TPI, coating thickness that can be correlated to both the mean dissolution time and the onset of dissolution. TeraView’s Alessia Portieri, PhD, details how.

Taking the Plunge to Harmonize Pharmaceutical Regulations
Within the past five years, more of world's regulatory agencies and pharmacopeias have gotten on the same wavelength.

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White Papers: In Depth Research

Best Practices from Baxter BioPharma: Optimizing Lyophilization and the Empirical Path to Cycle Development
Author: Baxter BioPharma
Posted: 11/10/2010
Using empirical, or science-based, freeze-drying approaches versus trial and error can help you navigate potential commercialization roadblocks.

Cartridge Filtration in the Production of Pharma Grade Water
Posted: 07/26/2010
Cartridge filtration can be a reliable, efficient means of producing bulk pharmaceutical grade water. This detailed paper from 3M illustrates its effective use for some of the most critical applications: the removal of particulates that might contaminate water systems, eliminating Pseudomonades and other microorganisms, reducing endotoxins, and protection of storage tanks during draw-down.

Increasing Tablet Press Productivity Using Segmented Turret Technology
Author: Fette America
Posted: 04/15/2010
Surveys of tablet press users reveal that machines with segmented turrets increase output and reduce set-up and cleaning time over conventional presses and previous turret technologies. This paper will discuss survey data from drug manufacturers using the technology and quantify some of the benefits over conventional press technologies.

Where and What to Test: From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product
Author: Microtest
Posted: 03/19/2009
This white paper focuses on what many consider the most critical part of a biological drug product’s manufacturing life cycle: going from the purified bulk drug substance (“PBDS”) to the sterile final drug product (“FDP”). Specifically, the white paper discusses establishing the testing “where and when” (and in some instances the “why”) for manufacturing formulation and fill/finish activities and how the approach is also applicable, for the most part, to small molecule drug products formulation and fill/finish.

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