Highlighted Sessions

High Potency API (HPAPI) Best Practices—Controlling Quality

Tuesday, April 30, 4:00pm–4:45pm

Andrew Leyhane, senior research scientist II, AMRI, discusses best practices for the quality control of HPAPIs.
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Extrusion Applications in Manufacturing Pharmaceutical Oral Drug Products

Wednesday, May 1, 10:30am–11:15am

This presentation will discuss basic principles of the extruder design and twin screw extrusion process, as well as the versatility of twin screw extrusion and its successful applications in manufacturing solid dosage forms. Important product and process development considerations for both hot melt extrusion and continuous granulation will also be covered.
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How Targeted Workforce Development Programs Can Support Derisking the Direct Materials Supply Chain

Wednesday, May 1, 10:30am–11:15am

Topics include derisking the direct materials supply chain, looking at an end-to-end approach to ensure assurance of supply, R&D/new molecular entity declaration through commercial launch, developing biopharma talent to ensure their support of the derisking model, and more.
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Geographically Integrated CMC Supply China–Speed Your Drug to Market

Wednesday, May 1, 11:45am–12:30pm

In this presentation, the benefits of geographically integrated chemistry, manufacturing, and control (CMC) services, as implemented in China, will be discussed. Case studies from both early phase and late phase projects will be presented to demonstrate its potential to enable further growth in the CDMO business.
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NEWS FROM CPhI NORTH AMERICA EXHIBITORS

Buffer Delivery Component for BioContinuum Platform

MilliporeSigma's BioContinuum Buffer Delivery Platform offers streamlined buffer management and delivers "contiGuous" bioprocessing.
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Catalent to Acquire Paragon Bioservices for $1.2 Billion

Catalent's acquisition of Paragon Bioservices will provide expertise in expanding gene therapy market.
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Hovione Technology Acquires Rights to New Blister-Based Inhaler

Hovione Technology has acquired global rights to a dry powder inhaler for pulmonary drug delivery, the Papillon DPI invented by Dr. Klaus-Dieter Beller.
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WuXi Biologics Completes First Routine FDA Inspection, Announces Partnership Plans

The company passed a seven-day FDA surveillance GMP inspection and announced two upcoming manufacturing partnerships.
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CPhI NORTH AMERICA 2019 EXHIBITOR PREVIEW

Patheon Thermo Fisher Scientific provides end-to-end development and manufacturing solutions to customers of all sizes through Patheon and Fisher Clinical Services, which deliver pharma services and clinical trials services. / read more /

USP USP's Ingredient Verification Program for Excipients includes a complete evaluation of your quality system. / read more /

NEW PRODUCTS AND SERVICES

Elizabeth Companies Elizabeth is the premier global supplier of compression tooling, rotary tablet presses, spare parts, blister feeding solutions, and services to the tableting industries. / read more /

Parenteral Drug Association The Parenteral Drug Association (PDA) is committed to developing scientifically sound, practical technical information and expertise to advance pharmaceutical/biopharmaceutical manufacturing science and regulation so members can better serve patients. / read more /

Sartorius Stedim Biotech As a total solutions provider, Sartorius Stedim Biotech offers a portfolio covering nearly all steps of biopharmaceutical manufacture. / read more /

Supplements Solid Dosage 2019 Supplement Issue Check out this month’s special issue, Solid Dosage Drug Development and Manufacturing, for articles on tableting, controlled release, powder handling, and more! The issue also includes our CPhI North America 2019 Planning Guide. View Online