Antibiotic Potency Testing: The Methods – Part 1

Using the Diffusion (Cylinder-Plate) Method 

Both the European Pharmacopoeia and the US Pharmacopeial Convention (USP) require testing of antibiotic potency using microbiological assays for some products. When the potency of an antibiotic is measured chemically, its concentration in solution is all that is determined. Conversely, a microbiological assay verifies the ability of the antibiotic to kill the target organisms, as well as the concentration at which the antibiotic will kill effectively.

A microbiological potency assay measures the effectiveness of an antibiotic by the degree of growth inhibition on susceptible strains of microorganisms at differing concentrations. One of the two methods defined in the pharmacopoeia to make this determination is the Diffusion (Cylinder-Plate) method.

Topics: Thought Leadership


Name: Christopher Williams
Alcami Site: Wilmington, NC

How long have you been with Alcami?
I have been with Alcami for six years.

What is your role?
I am the Manager of a Method Development and Method Validation group, which is part of the Development Services team at our Wilmington, NC location.

What is the most rewarding part of your job?
Having the opportunity to learn and help others around me learn every day.

Any interesting / cutting edge technologies or processes you (or your team) have been working on recently?
Recently we have embarked on a couple interesting/rewarding items:

Topics: Alcami Voices

Editorial: The Future of Pharma - Embracing a Changing Landscape

Stephan Kutzer, Alcami CEO & President, authored an article for manufacturing chemist's January 2017 issue titled "The Future of Pharma." The article discusses the future of the pharmaceutical industry, and embracing the changing landscape.

"If the pharmaceutical industry had to pick its favourite buzzwords from 2016, “innovation” would easily make the top five. Not necessarily because innovation exists in all corners of the industry, but because it is top of mind in nearly every area."

Topics: Thought Leadership

Need to Know: Details About Alcami's New St. Louis, MO Facility

You've probably heard by now that our St. Louis, MO site is relocating. The current Alcami St. Louis facility for laboratory operations will be transitioning to a new building being constructed at the following location:

4260 Forest Park Avenue
Suite 201
St. Louis, MO 63108

Read on to see what we have planned for our new state-of-the-art facility!

Topics: Company News

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 <231> by January 2018. Although the existing wet chemistry methods have been in effect for nearly 100 years, the methods are non-specific and frequently fail to detect or underestimate the presence of some toxic elements that are potentially present in pharmaceutical ingredients. The USP requires Plasma Spectrometry (ICP-MS or ICP-OES) as the technique to screen and/or accurately quantitate the presence of any elemental impurities of interest.  From a compliance perspective, the new guidance for elemental impurities (USP<232>and ICH Q3D) only applies to the drug product.  There are currently two strategies to meet the requirements for elemental impurities, with the first being a Risk-Based approach.

Topics: Regulatory Compliance

Alcami Donates Life-Saving LUCAS® 3 Chest Compression System to Germantown, WI Fire Department

Germantown, WI – January 31, 2017 – Alcami, a leading provider of custom development and manufacturing services for the pharmaceutical and biotechnology industries, today announces the donation of a Physio-Control LUCAS® 3 Chest Compression System, an electrically powered, portable life-saving medical device that facilitates the return of spontaneous circulation in cardiac arrest patients, to the Germantown Fire Department. Alcami operates a world-class Active Pharmaceutical Ingredient (API) manufacturing and development facility in Germantown, Wisconsin.

Topics: Company News

ON-DEMAND WEBINAR: Demonstrate Abuse-Deterrent Properties in Opioid Formulations

Prescription opioid abuse has reached epidemic levels in the United States, with nearly 20,000 deaths in 2014 (the most recent year for which statistics are available) from unintentional overdose of prescription opioids and nearly 36,000 deaths in which prescription opioids were either directly or indirectly implicated. This issue has become a major regulatory focus over the last several years and has resulted in the issuance of FDA guidances requiring abuse-deterrent properties for new opioid drug formulation NDA’s (final guidance April 2015) and generic ANDA’s (draft guidance May 2016). A major component of proving the abuse-deterrent properties for a new formulation is the execution of in vitro manipulation and extraction studies, which companies are increasingly turning to CRO’s to perform.

Topics: Webinars

Overview and Performance of the Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release (ER) and Long-Acting (LA) Opioid Analgesics

Several agencies within the U.S. Federal government are focused on reducing the prescription drug crisis the country is experiencing. How significant is the crisis?

Topics: Thought Leadership

Battling the Opioid Abuse Epidemic - Top 10 Important Guidances and Resources

Battling the opioid and overall prescription drug abuse epidemic has been a critical focus for many agencies within the U.S. government and industry. The following are a collection of important documents and resources that are important to this initiative.

Topics: Thought Leadership

The Effect of Abuse-Deterrent Formulations on Opioid Abuse

In 2011, the White House published “Epidemic: Responding to America's Prescription Drug Abuse Crisis,” which outlined a comprehensive strategy for responding to America’s prescription drug abuse crisis. This action was triggered by an alarming increase in drug overdose deaths in the United States from 1999 to 2010. During this time, overdose deaths from opioid pain relievers quadrupled, and have continued to increase.

Topics: Thought Leadership