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ON-DEMAND WEBINAR: Alcami Introduces Rapid Sterility

Rapid sterility is an alternative test method to the US Pharmacopeia (USP) General Chapter <71>, Ph.Eur. 2.6.1, and JP 4.06 sterility tests that allows for shorter incubation periods and faster results. Alcami is launching rapid sterility via the Milliflex® Rapid System, which uses adenosine triphosphate (ATP) bioluminescence for detection of microorganisms after five days. A fully comprehensive comparability study verifies adherence to USP/Ph.Eur. requirements for alternative microbiological methods and demonstrates that rapid sterility is a reliable alternative to the reference method.

In this webinar, Alcami’s rapid sterility expert, Stacey Ramsey, will introduce Alcami’s new rapid sterility platform and provide information for understanding implementation requirements. Stacey will also discuss the advantages of the rapid sterility platform as it compares to USP <71>. 

Topics: Webinars Rapid Sterility

Editorial: The Changing R&D Landscape

Dr. Imran Ahmed, Head of Formulation Development at Alcami, recently published an article in Pharma Tech Outlook. The article, The Changing R&D Landscape: Emerging Technology Needs and Value Proposition for Strategic Partnerships with Contract Development and Manufacturing Organizations (CDMOs), explains that as a result of pharmaceutical products becoming increasingly complex, new regulatory and manufacturing challenges are on the rise.

Excerpt from Ahmed: "The pharmaceutical product landscape is rapidly and fundamentally changing with profound impact on research and development strategy and technology needs. After a precipitous fall in new drug approvals during the last two decade of the 20th century, there has been a gradual recovery going into the second decade of the 21st century."

Topics: Thought Leadership Regulatory Compliance Editorials Development R&D

SCIENTIST SPOTLIGHT: September 2019

Name: Arne Van Mol

Alcami Site: Weert, Netherlands

What is your role? 
I am a process engineer at the Alcami site in Weert, Netherlands. My role is to scale up manufacturing activities in accordance with environmental, health and safety (EH&S) and current good manufacturing practice (CGMP) requirements.

How long have you been with Alcami?
My first experience with Alcami was during my internship in 2017. I had the pleasure of supporting the scale up of an active pharmaceutical ingredient (API) starting from a 2L reactor (150 grams of API) to a 400L reactor (36 kilograms of API).

I rejoined the Alcami team in November 2018 as a full-time employee.

What is the most rewarding part of your job? 
Working closely with R&D chemists in order to solve scale up obstacles and technical issues, such as emulsified phase separations or poor conversions, is the most satisfying part of the job.

Topics: Alcami Voices

Editorial: How to Find Your Secret Source

Alcami recently contributed to a special feature in The Medicine Maker magazine, titled "How to Find Your Secret Source."

Excerpt from Alcami: “I have a point of contention with the titles  ‘one-stop shop' or 'specialist supply chain’ because they imply that you can’t have both! If you have independent API and drug product, you can bring these together. Being that we were founded by merging two specialized organizations, we have experts in each area, which we then over arch with a structured offering to make sure they are properly integrated. A key thing our clients tell us – especially smaller clients who don’t want to manage a big supply chain – is that they like the internal efficiencies you can get with a one-stop shop."

Topics: Thought Leadership Supply Chain Editorials

Editorial: Considerations for Approval of Biosimilars

Alcami recently contributed to a special feature in the August / September issue of Chemicals Knowledge magazine, titled "Considerations for Approval of Biosimilars."

Biosimilars are sometimes incorrectly considered equivalent to a generic small molecule therapeutic, but for a biologic drug product, the clinical and regulatory pathways are quite different. Alcami Commercial Development Manager Cheryl Johnson explains the distinct differences in the FDA’s definition, development strategy, and regulatory approval pathways.

Topics: Thought Leadership Regulatory Compliance Biologics Editorials Parenteral Manufacturing

eBook: Analytical Testing in Drug Development

Alcami recently contributed to an eBook produced by Drug Development and Delivery. The eBook, titled "Analytical Testing in Drug Development," features four companies and explains how they each help the pharmaceutical and biotech industries comply with drug development regulatory requirements. 

Angela Moore, abuse-deterrence studies subject matter expert at Alcami, contributed to the eBook. Her article focuses on considerations for abuse-deterrent Category 1 studies as well as standard syringeability studies.

Topics: Thought Leadership Regulatory Compliance Abuse-Deterrence Editorials Development

WEBINAR: Alcami Introduces Rapid Sterility

Join Alcami on Wednesday, September 18, 2019 to learn more about rapid sterility. 

Rapid sterility is an alternative test method to the US Pharmacopeia (USP) General Chapter <71>, Ph.Eur. 2.6.1, and JP 4.06 sterility tests that allows for shorter incubation periods and faster results. Alcami is launching rapid sterility via the Milliflex® Rapid System, which uses adenosine triphosphate (ATP) bioluminescence for detection of microorganisms after 5 days. A fully comprehensive comparability study verifies adherence to USP/Ph.Eur. requirements for alternative microbiological methods and demonstrates that rapid sterility is a reliable alternative to the reference method.

In this webinar, Alcami’s rapid sterility expert, Stacey Ramsey, will introduce Alcami’s new rapid sterility platform and provide information for understanding implementation requirements. Stacey will also discuss the advantages of the rapid sterility platform as it compares to USP <71>. 

Topics: Webinars Microbiology Rapid Sterility