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.

With less than three months until the methods outlined in USP General Chapter <231> are retired, there is still much to discuss.

We’ve presented everything you need to know, including potential contamination sources, but we know there are still questions left unanswered.

This webinar will feature an extended Q&A with our panel of experts to answer any questions you have regarding what lies ahead.

Join Alcami for a webinar to learn more about the design approach to highly potent active pharmaceutical ingredient (HPAPI) suite design in a multi-use facility.

As new drug targets naturally become more potent in the search for more effective therapeutics, there is a growing demand for capacity and capabilities in support. The development and manufacture of Highly Potent Active Pharmaceutical Ingredients (HPAPI) in a multi-use facility faces challenges of technical, procedural and a perception-based nature. Fundamentally, it all starts with the use of the right tool for the job.

Join Alcami for a webinar to learn more about the future state of supply chain solutions.

From quality issues and drug shortages, to warning letters and natural disasters, today’s risks are significant and supply disruptions can be catastrophic. Therefore, having a secondary supply chain “on-call” is a must. When developing this innovative dual sourcing strategy, validation of processes with a reliable and flexible supplier protects against supply interruption. Alcami has designed Protect Your Brand™, a first-to-market initiative, to aid in the protection of supply chains.

With less than six months until the retirement of the methods outlined in USP General Chapter <231> on January 1, 2018, there’s still plenty to discuss regarding this regulatory change. An often overlooked scenario when testing for elemental impurities is the possible contamination from everyday pharmaceutical machinery. It’s important to understand and implement policies that can assist in a successful right-first-time risk assessment that accurately reflects your process.