banner

AAIPHARMA SERVICES - CAMBRIDGE MAJOR LABORATORIES

  • email
  • twitter
  • linkedin
  • facebook
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...

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...

Understanding Biologics: Your Top 7 Questions Answered
The biologics market represents the leading edge of novel therapeutics and is the fastest growing cross-section of the pharmaceutical...

Case Study: Implementing Serialization
The Food and Drug Administration (FDA) issued a draft guidance listing the enforcement of product identifiers under the Drug Supply Chain...

https://media.caboodleai.net/pda/companies/35bdc39a-d095-4279-aa98-1cde67492651.com.png

NC,
United States