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>. 

A microbial in-use (admixture) study is performed to evaluate the growth of low-level microorganisms inoculated into the diluted drug product and tested at several time points over the prescribed administration time. These studies are performed to determine if microbial growth will be supported and/or proliferate in the product during the holding period prior to patient administration in the event of inadvertent microbial contamination during product dilution. It is important to understand and comply with the timelines and deadlines surrounding these microbiological procedures. 

In this webinar, Alcami’s admixture studies expert, Brent Harlow, will guide you through the necessity of these studies and how to successfully perform them for FDA approval. 

By some estimates, the pre-approval cost of drug development is a staggering $2.5 billion per drug and takes an average of ten years from discovery to reach market. For novel therapeutics, the highest risk is during early phase development, and biologics are no different. However, biologics drug product manufacturers face some unique challenges because they are made from biological sources. Some of these challenges are batch-to-batch consistency, changing impurity profiles, and molecular instability.

Requirements from regulatory agencies have become increasingly rigorous with regards to the detection, identification, and quantitation of extractable and leachable compounds in pharmaceuticals, drug delivery systems, and biomedical devices. This heightened scrutiny is the result of several well‐documented incidents of contaminants leaching from containers and packaging, causing potential or real risk to humans. Therefore, regulatory agencies, such as the US Food and Drug Administration (FDA) and the European Medicines Evaluation Agency (EMEA), have increased regulations on potential extractables and leachables in drug product container and closure systems.

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.

As of July 2017, America’s opioid crisis has been declared a state of emergency. In order to help combat prescription opioid drug misuse and abuse, pharmaceutical drug companies are developing and commercializing drug products that have abuse- deterrent features. The FDA issued guidance in April 2015 for new drug applications (NDAs), and suggested guidance in March 2016 for generic abbreviated new drug applications (ANDAs) to aid in the formal evaluation of the abuse-deterrent nature of drug products. A crucial test for drug products that are abused intravenously are syringeability studies. Because most syringeability studies are performed exclusively in-vitro due to the hazardous nature of abuse-deterrent formulation excipients, accurate experimental design is crucial and carefully reviewed by the FDA.