Component Selection Equates to Successful Sterile Fill-Finish Manufacturing
Excerpted from Drug Development & Delivery's Special Feature Section titled, "Prefilled Syringes & Parenteral Manufacturing: Innovations,...
Introduction to Quality by Design
Since Joseph Juran’s concept of Quality by Design (QbD) was first adopted by the US Food and Drug Administration (FDA), the pharmaceutical...
Antibiotic Potency Testing: The Methods - Part 2
Using the Turbidimetric Method
In part one of this blog series, we discussed Antibiotic Potency Testing using the Diffusion...
In part one of this blog series, we discussed Antibiotic Potency Testing using the Diffusion...
WHITE PAPER: Extractables and Leachables Testing in the Pharmaceutical Industry
Alcami has recently authored a white paper on extractables and leachables testing in the pharmaceutical industry. Requirements from regulatory...
Elemental Impurities: The Risk-Based Approach
The U.S. Pharmacopeia (USP) intends to remove the existing wet chemistry heavy metals methods outlined in USP General Chapter by January 2018....
Editorial: A Practical Approach to Extractables & Leachables
Alcami recently authored an article featured in Drug Development & Delivery titled "A Practical Approach to Extractables &...
Serialization CDMO Checklist
Given that serialization execution is new to many in the industry, what should drug developers look for when reviewing a new contract...
PART I: HPAPI Market Forecasts and Manufacturing Challenges
In this two-part blog series, Alcami Senior Director of Global Manufacturing Science and Technology, Adam Kujath, discusses the main...



