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.

Join Alcami for a webinar to learn more about submitting samples through Alcami OnDemand, a customer portal that provides clients unprecedented and rapid access and visualization into ongoing projects. 

Using Alcami OnDemand to submit Analytical Testing projects is a simple process that will save you time and streamline project tracking. This webinar will detail the finer points of online sample submission. We will show you how to build a sample submission project in Alcami OnDemand and walk you through the following processes:

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.

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.

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.

Join Alcami for a webinar to learn more about Alcami OnDemand™.

Introducing a faster and easier way to submit your samples. Our Alcami OnDemand™ portal has been designed to streamline engagement, provide additional insight into our work efforts, and ultimately – unprecedented access, transparency, and visualization into your project work. 

Join Alcami for a webinar to learn more about elemental impurities and the updated regulatory requirements.

It’s official! The methods outlined in USP General Chapter <231> are retired. If you missed the January 1, 2018 deadline, we are here to help. Our in-house experts will share our approved testing plan that can be submitted to the FDA to help ensure you are moving to compliance, and will highlight experiences gained while working with the new regulations.

Join Alcami for a webinar to learn more about accelerating drug development through automation.

Drug development is based on making the right decisions at the right moment; where R&D focuses on providing that information as rapidly as possible. At Alcami, we use automation as a tool to provide the overall design space of the reaction sequence, form selection and crystallization from gram to multi-kilogram scale. The approach of combined Principle Component Analysis (PCA) and Design of Experiments (DoE) provides a broad overview, with a high diversity in conditions and optimal route for further development. The integrated process chemistry, analytics and pre-formulation allow for a parallel approach to the program that shortens timelines without the loss of information due to transfer between departments and/or companies. The seamless integration of these activities eliminates unnecessary repetition of what has worked before by secondary labs and keeps the research at Alcami focused on finding the best overall conditions to optimize quality and quantity.

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.