How Alkermes Built Oral Solid Dose Expertise Without Compromising Quality
Mike Hale shares how Techceuticals helped Alkermes train its team for its expanding oral solid dose portfolio.
The biggest thing that I took away from the courses here and all of the instructors that really, really impressed me was their focus on product quality and process quality and building that into how you manufacture your oral solid dose products.
Alkermes is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience and has a diverse portfolio of proprietary products approved for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder. With a strong commitment to improving patients' lives, Alkermes has a rich history of scientific innovation and a diverse portfolio of products. Mike Hale serves as the Senior Director of Manufacturing Operations at Alkermes' Wilmington, Ohio facility.
The Challenge
As Alkermes' portfolio evolved to focus more on oral solid dose manufacturing, they faced the challenge of ensuring their team had the necessary expertise and training. While already experts in sterile manufacturing, the shift required cross-functional training for their QA, engineering, manufacturing, and support functions to achieve a consistent level of expertise in oral solid-dose production. The goal was to adapt to their expanding oral solid-dose portfolio while maintaining their high standards of product quality.
The Solution
Alkermes partnered with Techceuticals to provide comprehensive training for their team. Techceuticals offered a unique combination of diverse equipment availability and strong relationships with various providers of oral solid-dose manufacturing equipment. This allowed Alkermes' team to gain hands-on experience with a wide range of technologies without bias towards a single vendor. The training focused on fundamental concepts and principles required to produce high-quality tablets, regardless of the specific equipment used.
The Results
Through training with Techceuticals, Alkermes' team gained invaluable knowledge and skills in oral solid-dose manufacturing. The emphasis on product and process quality from the instructors resonated deeply with Mike Hale and his team. This focus is crucial in pharmaceutical development, where materials are scarce and making medicine right the first time is paramount. The training also highlighted the importance of equipment upkeep and maintenance to ensure consistent quality output.
The biggest thing that I took away from the courses here and all of the instructors that really, really impressed me was their focus on product quality and process quality and building that into how you manufacture your oral solid dose products. Materials, especially when you're developing medicines, are very scarce. There's not a lot of that time or material on hand in order to make those key batches for your clinical supply, especially. And so product quality is paramount in order to be able to make that medicine right the first time. Getting training from folks like we've gotten here at Techceuticals is key. Focusing on the upkeep and maintenance and care of the equipment to make sure that when we need to use it, it's able to be used and able to put out a quality product.
