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SCIENTIST SPOTLIGHT: July 2018

Name: Frank Nijnens
Alcami Site: Weert, Netherlands

How long have you been with Alcami?
I joined the company in August 2006.

What is your role? 
Within my project team I fulfill the role of Analytical Project Leader. I am responsible for safeguarding the timely development and quality of the needed analytical package to support the development of process routes and to support pilot plant campaigns, appropriate for the cGMP status of the project.

What is the most rewarding part of your job?
The joy of my work is meeting and exceeding expectations and overcoming challenges by combining all expertise within our project team (analytical, solid state, and organic chemistry). Knowing the strengths of each individual helps in solving analytical challenges within a condensed period of time. The positive feedback from our clients is the best recognition you can get.

Topics: Alcami Voices

ON-DEMAND WEBINAR: Balancing HPAPI Control with the Chemistry and Efficiency Needs of a CDMO

Effective high containment API manufacturing has certain expectations and requirements; similarly, being a successful contract development and manufacturing organization (CDMO) has its own distinct challenges. When the demands of these two worlds meet, the ability to balance both offers a unique challenge.

Topics: Webinars API HPAPI

Considerations for Abuse-Deterrent Category One Syringeability Studies

The use of opioid medications for pain management continues to increase, generating an inevitable association with abuse and addiction. Government officials and pharmaceutical professionals alike are in need of risk mitigation approaches (Katz, 2008). The Abuse Deterrent Access Act of 2018 requires Medicare and Medicaid to report to Congress the availability of abuse-deterrent opioid pain treatments. The bill is meant to decrease the amount of barriers for their enrollees (Carter, 2018).

The U.S. Department of Health and Human Services (HHS) has estimated that in 2016, the most recent year for which complete data are available, over 42,249 Americans died from opioid overdoses, the most of any year on record. More than 2.1 million Americans had an opioid use disorder (addiction) in 2016, with economic costs from the epidemic estimated to be as high as $504 billion dollars (Johns Hopkins University Bloomberg School of Public Health, 2018).” Pharmaceutical companies have responded to this need through more stringent abuse-deterrent formulations and studies.

Topics: Thought Leadership Abuse-Deterrence

The Role of Full Time Equivalent (FTE) Programs

An FTE agreement is considered a comprehensive analytical service that allows pharmaceutical and biotech companies flexibility, freedom, and consistent control of outsourced laboratory needs.

Drug developers with an abundance of overflow lab testing or limited lab space and staffing are ideal candidates for what Alcami calls an Extended Workbench program. Additional support may also be critical if the US Food and Drug Administration (FDA) approves the acceleration of your drug product. The chart below is a summary of the FDA’s drug development descriptions for when a product has significant implication on a patients’ welfare (FDA, 2018).

Topics: Analytical Development Analytical Testing Development Drug Product

Alcami Renews Partnership with Wisconsin Department of Natural Resources to Revitalize State Trails

Durham, NC (USA) – July 18, 2018 – Alcami Corporation, a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biotechnology industries, today announced a renewed partnership with the Wisconsin Department of Natural Resources (DNR) to revitalize and repair the Hank Aaron State Trail in Milwaukee, Wisconsin, and the Pike Lake Hiking Trail in Hartford, Wisconsin. Volunteers from Alcami’s Germantown, Wisconsin Center of Excellence for active pharmaceutical ingredient (API) development, scale-up, and commercialization will work alongside Wisconsin DNR trail coordinators and park superintendents to renovate the popular state trails.

Topics: Company News Alcami in Action

eBook: Guide to Stability

Stability is an integral part of the drug development process. With every stability study, it is essential to focus on the quality attributes of the product— most importantly safety.

Throughout this guidebook, Alcami scientists will discuss stability testing procedures, the  “how” and “what” of degradation in the measurement of shelf life, the importance of storage conditions, and the necessity of following a medication’s recommended guidelines.

 


Topics: Resource Center Stability Analytical Testing

ON-DEMAND WEBINAR: Successful Application of the New Elemental Impurities Regulation

Join Alcami and the Division of Pharmacy Professional Development at UW-Madison for a webinar: Successful Application of the New Elemental Impurities Regulation.

The recent changes to the elemental impurities regulation guidelines increase the level of control necessary in testing for heavy metals in pharmaceutical and biotherapeutic products. The use of inductively coupled plasma (ICP) instrumentation is considered the ideal method to determine elemental impurities present in drug products and raw materials. This approach has been proven to be accurate, sensitive, linear, and satisfactory to include in filing reports.

Topics: Webinars Elemental Impurities Regulatory Compliance