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, 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

Embracing Formulation Expertise to Extend Exclusivity & Improve the Patient Experience

Screen_Shot_2016-09-22_at_3.04.09_PM.pngAs published in Pharma's Almanac Q3 2016.

Offering potential exclusivity and access to larger markets, reformulation efforts can prove extremely valuable to both pharmaceutical and biopharmaceutical manufacturers. With reliable CDMO support, this value can be developed in a cost-effective manner and with minimal inconvenience, while reducing the impact of patent loss.

With considerable room for growth in emerging markets, the surge in biopharmaceutical drug development and approvals, as well as merger and acquisition activities that are helping to further existing expertise, has left the pharmaceuticals market poised for growth. At an expected compounded annual growth rate (CAGR) of 4% to 7%, the market is predicted to reach $1.3 trillion in 2018, but challenges still exist as traditional pharmaceuticals are rapidly approaching or have already reached the patent cliff and biopharmaceuticals are beginning to experience competition from biosimilars. Faced w

Topics: Thought Leadership

Rigorous Integration in a Scalable Development and Manufacturing Enterprise to Support Continued Growth of Biopharmaceuticals

Screen_Shot_2016-09-22_at_3.08.36_PM.pngAs published in Pharma's Almanac Q2 2016.

The pharmaceutical and biopharmaceutical development and manufacturing market continue to experience significant expansion as the development of small molecule drugs and more complex large-molecule biologics rival for attention. Small and midsize pharma/biotech companies
are leading drug discovery and the engagement 
of contract development and manufacturing organizations (CDMOs) helps them to improve capabilities and enable companies to compete 
in this dynamic market.

Topics: Thought Leadership

Strengthening CDMOs to Meet Industry Needs For 2016 And Beyond


As published in Pharma's Almanac Q1 2016.

Outsourcing companies pursuing an integrated services model aim to facilitate drug development and commercialization for drug sponsors by enabling them to work with a single partner for activities that often require multiple, specialized vendors.

With a single qualified partner, pharma companies can have simplified access to integrated analytical, devel- opment, manufacturing and packaging services, as well as a broad range of dose form manufacturing and simi- lar services. Some contract development and manufac- turing organizations (CDMOs) offer both API and drug product manufacture, while others offer formulation development and clinical supply manufacture to com- plement their commercial production operations. Re- gardless, the aim is to provide a seamless supply chain solution.

Topics: Thought Leadership