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Pharmaceutical Manufacturing and Packing Sourcer
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What was the strategic driver behind your research?
Julie Suman: Several complex challenges are facing injectables component partners, from increased safety and quality requirements to development of sensitive drug formulations, which necessitate the creation of more inert solutions with greater regulatory standards. Drug product manufacturers need flexibility to select components that meet their sterilisation requirements.
What is the regulatory case for extractables and leachables?
Injections and injectable suspensions have the highest degree of concern associated with the various routes of administration, as far back as the guidance document issued by the FDA in May 1999. Current expectations have increased with new methodology defined in the US Pharmacopeia and Product Quality Research Institute (PQRI) parenteral and ophthalmic guidelines. There is also a high likelihood of packaging component/dosage form interaction, hence the intense scrutiny in this area.
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Julie Suman, RPh, PhD, is the Founder of Next Breath, an Aptar Pharma business, and serves as its President. Julie holds a BS in pharmacy from Duquesne University, US, and a PhD in pharmaceutical sciences from the University of Maryland, Baltimore, US. She is co-editor of the Respiratory Drug Delivery Proceedings, an international symposium, and an Affiliate Assistant Professor in the Department of Pharmaceutics, School of Pharmacy, Virginia Commonwealth University, US. Julie is also a member of the Parental Drug Association Visible Particulate Taskforce. |
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News and Press Releases |
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ACG to Showcase its Range of Capsules and Engineering Solutions at Supply Side West, Las Vegas
ACG, the only supplier in the world offering end-to-end manufacturing solutions for the pharmaceutical and the nutraceutical industries, will be exhibiting its wide range of Engineering and Capsules solutions at this year’s Supply Side West, Las Vegas. At ACG’s booth, the visitors will be able to see the synergies created with coupling ACG’s Capsules and Engineering products, thereby leveraging the many benefits of integrated manufacturing.
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White Papers |
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Bringing more control to temperature-sensitive logistics
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Industry Events |
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Drug Delivery Partnerships 2019
28-30 January 2019, PGA National Resort & Spa in Palm Beach Gardens, FL
For 23 years, DDP has been the world’s largest drug delivery meeting place to accelerate drugs to market and lengthen lifecycles for long term profitability by finding new partners, new drug delivery technologies, and new formulation development strategies.
Year after year this event brings together top scientists and business development leaders from Biotech, Pharma, Generics, Specialty Pharma and Drug Delivery companies to share, discuss, and collaborate. If you work in drug delivery, commercialization/licensing, med device, formulation, biologics, biosimilars, and similar areas, you can’t miss this event!
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