BlogHeader.png

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