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For decades, the power and potential of outsourcing has been viewed as a way for pharmaceutical companies to gain access to specialized domain expertise across geographic regions and achieve cost savings amidst a highly complex and diverse regulatory environment. In the face of dwindling drug pipelines, complex regulations and block-busters crossing their patent exclusivity, mature products offer a revenue stream for companies to sustain their bottom lines in a hyper-competitive global market.

In this episode of Drug Digest, Chris Spivey, editorial director, and Meg Rivers, senior editor, dive into APIs, excipients, and formulation advances, specifically pairing the right APIs and excipients for optimizing formulations.

Cell and gene therapies continue to expand rapidly, with an anticipated exponential growth over the next five years. This rapid growth has left an urgent need for industry scientists to gather and share lessons learned concerning bioanalytical, biomarker and regulatory strategies. This series provides insight from PPD Laboratories’ experts into a variety of cell and gene therapy (CGT) modalities in the bioanalytical community, with detailed discussions that leverage their experience with technologies and modalities within this CGT sphere.

Leila Giarola, a scientist at Ashland Specialty Ingredients, presented the company’s poster Evaluation of a Novel Titanium-Free Film Coating Formulation with Whiter, Brighter and Glossier Finish at AAPS 2021 PharmSci 360.

Eshani Nandita, Ph.D., Global Biopharma Quant Technical Marketing Lead at Sciex, presented the company’s poster Ultra-Sensitive LC-MRM Analysis for Trastuzumab emtansine Quantification in Rat Plasma at AAPS 2021 PharmSci 360.

Tarun Mutukuri, Ph.D. from Purdue University presented Fluid Air’s poster Electrostatic Spray Drying to Produce Solid Protein Formulations at AAPS 2021 PharmSci 360.

Nanoform’s Eric Peter talks about what Nanoform showcased at AAPS 2021and what makes Nanoform’s particle engineering solutions unique.

Manish Ghimire, Ph.D., Product Development Manager at Colorcon, Inc., presented the company’s poster Impact of Opacifier Type in a Film Coating Formulation on Photostability of Tablet Ingredients at AAPS 2021 PharmSci 360.

Daniel To, Ph.D., Product Development Manager – Film Coatings, at Colorcon, Inc. presented the company’s poster Performance and Stability of an On-Dosage Authentication Technology Using Molecular Tags on the Coated a Model Active at AAPS 2021 PharmSci 360.

Element offers comprehensive solutions for the entire product lifecycle.

Learn how CDMOs have integrated and delivered innovation to advance customers from curiosity to cure.

Dr. Prasad Raje, CEO of LGM Pharma, explores the importance of investing in robust analytical testing services, how pharma companies can leverage contract analytical services to save on costs and reduce development times, and more.

Pharma companies find ways to maintain quality standards, despite pandemic-related restrictions.

Lessons learned from the pandemic can advance future biologic drug development and manufacturing.

The importance of characterizing excipients, supply chain security, and the role of novel excipients are explored.