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

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

Editorial: Analytical Testing: Market Drivers, Growing Demand & Client Needs

Alcami recently contributed to a special feature in Drug Development and Delivery magazine titled "Analytical Testing: Market Drivers, Growing Demand & Client Needs." The article includes Alcami, along with other analytical testing providers discussing a variety of topics including service offerings, identifying trends, and how each company specifically addressed clients’ needs during the past year. 

Topics: Thought Leadership

Editorial: Supply Chain Management and the Importance of Security of Supply

As published in Pharma's Almanac Q4 2016.

As global demands rise, supply chains are
becomingly increasingly complex. Of course, with
this increased complexity comes increased risk of
error and, more significantly, increased risk of supply
disruptions and drug shortages. In order to prepare
for the possibility of unforeseen events affecting
the supply chain, contingency plans are a priority.
Alcami’s innovative Protect Your Brand™ is a key
example of this type of security service, offered
through an outsourcing partner.

Topics: Thought Leadership