Bringing the Light to Photostability in Three Parts - Part 2

Part 2: Forced Degradation Studies to Support Photostability  

In Part One of this photostability blog series, a high level review on the background of photostability was presented.  In this second part, work leading up to the execution of a photostability study on Active Pharmaceutical Ingredient (API) and pharmaceutical products will be discussed. 

Prior to execution of a photostability study, the analytical test procedures (TP) must demonstrate the ability to detect degradants caused by photolysis (photodegradation).  Not all compounds are susceptible to photolysis; a molecule must absorb the UV or visible light energy to be susceptible to this phenomenon.  For example, if the absorption spectrum of a molecule has a maximum of ~254 nm and with minimal or no absorption above 300 nm, this molecule would not be susceptible to photodegradation during an ICH photostability study as the lowest wavelength of exposure is ~320 nm. 

Topics: Thought Leadership

Editorial: Formulation Development & Manufacturing — CDMOs Offer Speed, Advanced Technologies, & the Ability to Handle More Potent APIs

Alcami recently contributed to a special feature in Drug Development and Delivery magazine titled "Formulation Development & Manufacturing — CDMOs Offer Speed, Advanced Technologies, & the Ability to Handle More Potent APIs." The article includes Alcami, along with other CDMOs highlighting their capabilities in the areas of speed, quality, technology, and handling of complex APIs.

Topics: Thought Leadership

Bringing the Light to Photostability in Three Parts

Part 1: Basic Requirements – Setting the Stage

ICH Guidance Q1B was published in 1996 describing a harmonized approach to photostability studies.  Although it has been 20+ years since its publishing, questions still arise on how to execute a photostability study and how to interpret the results.  In this blog series, I will address common questions and detail how a photostability study is executed.  At Alcami, photostability is conducted at three laboratory sites: Wilmington, NC; Edison, NJ; and St. Louis, MO.

A photostability study is performed using either a full spectrum light source that produces a spectrum similar to D65/ID65 emission standard, or two separate light sources: one for near UV radiation with a spectral distribution from 320 nm to 400 nm with a maximum energy emission between 350 nm and 370 nm, and a second light source that is a cool white fluorescent lamp designed to produce an output similar to that specified in ISO 10977.  Regardless of which approach is taken, the objective is to expose samples to an integrated amount of NLT 200 Watt·hrs/m2 of near-ultraviolet energy and NLT 1.2 million lux·hours of visible light. 

Topics: Thought Leadership

Editorial: Alcami Featured in Pharma Horizon's January 2017 Issue

Syed Husain, Alcami CCO is featured in an article published in Pharma Horizon's January 2017 issue. The article, written by Cynthia Challener, Scientific Content Director at That's Nice, LLC discusses next-generation therapies: overcoming bioprocessing, characterization and logistics challenges. 

Topics: Thought Leadership

Executive Q&A: Keys to Cultural Integration

As published in Pharma's Almanac Q1 2017.

Catherine Hanley, Alcami Director of Marketing, discusses with Nigel Walker of That's Nice how to successfully integrate after a merger.

Why is cultural integration following a merger so important to the success of the newly formed entity?

The impact on employee morale and turnover can be painfully high during and after a merger, and repairing it can be nearly impossible. If cultural integration doesn't happen, companies see significant and costly consequences.


Topics: Thought Leadership

Editorial: Supporting the Pharma Industry Small Business Growth Engine

As published in Pharma's Almanac Q1 2017.

Small and medium-sized companies generate
greater than two-thirds of the clinical candidates
in the pharma and biotech industry drug pipeline.
They often, however, lack the knowledge and
resources required to take a new medicine from
the lab to the market and need support
from CDMOs that offer integrated, tailored,
customized solutions and personalized
technical support.

Topics: Thought Leadership

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 (Cylinder-Plate) method.

Antibiotic potency assays using microbiological methods are required by both the European and United States Pharmacopoeia for some antibiotic products. Physicochemical methods, such as immunological assays and High-Performance Liquid Chromatography (HPLC) have become commonplace for determining the concentration of API and for the concomitant determination of Assay and impurities. However, microbiological assays provide a true measure of how effectively an antibiotic kills or inhibits a target microorganism at a specified concentration.

Topics: Thought Leadership

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

Editorial: The Future of Pharma - Embracing a Changing Landscape

Stephan Kutzer, Ph.D, 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

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