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ON-DEMAND WEBINAR: Approach to HPAPI Suite Design in a Multi-Use Facility

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.

Topics: Webinars HPAPI API

ON-DEMAND WEBINAR: The Future State of Supply Chain Solutions

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.

Topics: Webinars Supply Chain

ON-DEMAND WEBINAR: Elemental Impurities - A Deep Dive into Potential Contamination Sources

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.

Topics: Webinars Elemental Impurities

ON-DEMAND WEBINAR: Get on Track with Serialization - Lessons Learned

Join Alcami for an on-demand webinar, discussing the challenges and complexities of serialization implementation.

As the pharmaceutical industry races to meet the Drug Supply Chain Security Act (DSCSA) November 27, 2017 deadline, the challenges and complexities of serialization implementation must be understood. 

Topics: Webinars Serialization Supply Chain

ON-DEMAND WEBINAR: Elemental Impurities - Everything You Need to Know

The introduction of new guidelines relating to elemental impurities in pharmaceuticals from the International Conference on Harmonization (ICH), U.S. Food and Drug Administration (FDA) and United States Pharmacopeia (USP) has created new and complex challenges for the pharmaceutical industry. These challenges include replacing the wet chemistry “heavy metals” limit test with new analytical technology, specifically, inductively coupled plasma (ICP) –based technologies and mandated conformance to new and specific limits for individual elements.  From a compliance perspective, the new guidance for elemental impurities (USP<232>and ICH Q3D) only applies to the drug product and the materials/processes involved.

Are you ready for this regulatory change?

Topics: Webinars Elemental Impurities

ON-DEMAND WEBINAR: Critical Drug Substance Considerations for Formulation Success in Drug Product Development

Join Alcami for a webinar discussing critical drug substance considerations for formulation success in drug product development.

Understanding the solid state properties of a drug candidate molecule is of critical importance for successful dosage form development. It takes close collaboration and communication between solid state characterization scientists, synthetic process chemists, analysts and engineers, and formulation development personnel to reduce risk, both in time and cost. 

Topics: Webinars

ON-DEMAND WEBINAR: Demonstrate Abuse-Deterrent Properties in Opioid Formulations

Prescription opioid abuse has reached epidemic levels in the United States, with nearly 20,000 deaths in 2014 (the most recent year for which statistics are available) from unintentional overdose of prescription opioids and nearly 36,000 deaths in which prescription opioids were either directly or indirectly implicated. This issue has become a major regulatory focus over the last several years and has resulted in the issuance of FDA guidances requiring abuse-deterrent properties for new opioid drug formulation NDA’s (final guidance April 2015) and generic ANDA’s (draft guidance May 2016). A major component of proving the abuse-deterrent properties for a new formulation is the execution of in vitro manipulation and extraction studies, which companies are increasingly turning to CRO’s to perform.

Topics: Webinars Abuse-Deterrence

WEBINAR: Critical Drug Substance Considerations for Formulation Success in Drug Product Development

 

Join Alcami for a webinar on Tuesday, December 20, discussing critical drug substance considerations for formulation success in drug product development.

Understanding the solid state properties of a drug candidate molecule is of critical importance for successful dosage form development. It takes close collaboration and communication between solid state characterization scientists, synthetic process chemists, analysts and engineers, and formulation development personnel to reduce risk, both in time and cost.

Topics: Webinars

WEBINAR: How to Submit a Sample Using Alcami’s Enhanced Online Sample Submission Process

 

Join Alcami for a webinar on Monday, November 7, discussing how to submit a sample using our enhanced online sample submission process.

As an industry leading and innovative organization, Alcami continues to evaluate and improve our processes to create the best client experience. In doing so, Alcami has enhanced the user experience and the ease of submitting samples for analysis.  

Topics: Webinars