Pharmaceutical Packaging Applications & Studies
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Five Year Trouble Free Manufacturing For Large Pharma Company
9/28/2011
Alkermes, through the merger with Elan Drug Technologies, to become Alkermes plc, has been developing and manufacturing commercial scale solid oral dosage products for over 40 years.
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Aptuit Blister Packaging Case Study
4/28/2011
A client, in need of global blister packaging, had received an exorbitant estimate from a Clinical Packaging and Logistics provider other than Aptuit.
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Informatics For Neglected Diseases Collaborations
4/20/2011
Many different public and private organizations from across the globe are collaborating on neglected diseases drug-discovery and development projects with the aim of identifying a cure for tropical infectious diseases.
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Case Study: Comprehensive Preclinical Development Program
4/9/2010
Aptuit was asked to conduct an extended package of preclinical studies within a short time frame. As the critical studies are dependent on the results of earlier work in the package (for example, initiation of the 28 day toxicology studies are dependent on the completion of bioanalytical method development, dose range finding, etc.) not only scheduling, but adherence to the schedule was the major risk to achievement of the overall aim, and on time filing to the regulator. By Aptuit, Inc.
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Case Study: Product Development Of An Inhaled Protein
4/9/2010
A small biotechnology company in the United States turned to Aptuit to support the development of their inhaled respiratory product. They had added confidence that their limited in-house capability would benefit from Aptuit’s substantial experience and capabilities in respiratory science projects, fulfilling their need for first-in-class capabilities in manufacturing, clinical packaging and logistics, bio-analytics and respiratory analytics. By Aptuit, Inc.
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Product Development Of An Inhaled Protein
4/9/2010
A small biotechnology company in the United States turned to Aptuit to support the development of their inhaled respiratory product. They had added confidence that their limited in-house capability would benefit from Aptuit’s substantial experience and capabilities in respiratory science projects, fulfilling their need for first-in-class capabilities in manufacturing, clinical packaging and logistics, bio-analytics and respiratory analytics. By Aptuit, Inc.
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Case Study: Controlled Drug Handling
4/9/2010
A midsize pharmaceutical company came to Aptuit to work through the complexities of exporting a controlled substance manufactured in the United States and an EU-sourced comparator for inclusion in a clinical trial across more than 12 EU participating countries. Aptuit’s client was dealing with an Investigative Medicinal Product (IMP) manufactured in the United States and an EU-sourced comparator. By Aptuit, Inc.
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Case Study: IND Preparation and Submission - Fast-Track Re-Submittal of pre-IND
6/27/2006
Prepare and submit an FDA guidance-compliant pre-IND package
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Stick Packaging Delivers Portability, Convenience
Stick packaging offers portability and convenience and can be used as an alternative to bottles and blister packaging. Read more about this packaging and a packager providing a way to ease product use.
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The Power Of Partnership: Supporting Rapid Global COVID-19 Manufacture
One company that developed a COVID-19 vaccine, shares the partnership that simplified tech transfer and helped them overcome challenges with analytical methods to meet their aggressive timelines.