The SmartPlatform Review Part 2

This is our final newsletter before CPhI Conferences Barcelona 2023 next week. We are wrapping up our tour of the SmartPlatform Portfolio and taking a look at "Chiral Purity Analysis." As always, we have the Media Center with webinars and papers from across SK pharmteco, along with our "Road Show" list of upcoming conferences.

The SK pharmteco SmartPlatform Portfolio?

The SmartPlatform Portfolio is a small molecule CDMO solution that seamlessly unifies the technologies for which SKPT is renowned. Each Platform represents decades of experience and, in many cases, unique technologies within the industry.

The Portfolio allows either the utilization of a single Platform as a standalone offering or in any configuration with other Platforms your project requires. You can be assured that you will receive the same service for your project - regardless of the number of Platforms needed. However, the real differentiator is why we call it the SmartPlatform Portfolio: the integrated technologies and, notably, the service that come into play when moving your project from conception to commercialization.

You Can Stand Behind SmartShield

SK?pharmteco?maintains R&D laboratories dedicated to high-containment chemistry and a dedicated facility for preparing and handling highly potent compounds...

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SmartForm is the Shape of Material Science

Our expertise and extensive testing capabilities in material physical attributes (PXRD, DSC, TGA, DVS, surface area, material flow properties and?rheometry, optical and hot stage scanning electron microscopy, FT-IR/NIR, Raman spectroscopy).?Our crystallization expertise allows?...

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Why SmartTest is the Answer to Analytical Services

Our experts behind SmartTest are the components that make?the platform extremely effective. SKPT has a strong record of regulatory training. We have trained over 230 FDA personnel at our location in California since 2014. In other words, we train the regulators. We can supply the support required for regulatory filings, patent/IP efforts, and create phase-appropriate development and validation, from concept to commercialization. Specialties...

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Chiral Purity Analysis – The Need to Know What Both Hands Are Doing

Background on Chiral Purity

Chirality refers to the phenomenon that occurs when a mirror image cannot be superimposed. It is sometimes called “optical rotation”. The origin is from the late 19th-century Greek word kheir (‘hand’) and is one of the easiest demonstrations of the concept. Although a person’s hands may appear virtually identical, if they were switched, the outcome would be very different. Amino acids and sugars are the chiral building blocks of larger molecules such as peptides, proteins, and nucleic acids. Therefore, those polymers, in turn, are chiral as well.1Molecules with chiral centers may have...

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Media Center

Center for Breakthrough Medicines Webinar: Driving Efficiencies in Cell and Gene Manufacturing with Digitalization and Program Management With cell and gene therapy development and manufacturing an increasingly complex endeavor compared to prior modalities, paper and audit-based collaboration models can add overhead and inefficiencies to already compressed timelines.

Experts will explore:

• Identifying key technology investments (e.g., MES, data lake, in-process analytics) as the foundation for automation and AI integration
• Understanding the critical role of in-suite camera and sensor systems in deviation management and root cause analysis
• Harnessing the power of real-time access through dashboards and video feeds to augment in-person suite access and enabling.

AMPAC Analytical White Paper:?Method Development & Impurity Control in Late-Phase API Manufacturing This is the companion paper of our recent webinar, still available below, presented by the Director of AMPAC Analytical, Shankar Sankaran. It is courtesy of?LCGC, and you can download it from their site. Check it out here.

AMPAC Analytical Webinar:?Method Development & Impurity Control in Late-Phase API Manufacturing

Yposkesi webinar:?Analytical Quality by Design Approach: A Challenge for Viral Vector Testing in Gene Therapy

SK pharmteco Company Meetings

SK pharmteco companies, including AMPAC Analytical, will be attending these upcoming shows and hope to see you there (click through the links for more details).

• European Society of Cell & Gene Therapy??October 24–27, 2023, at the Avenue du Port 86C, Brussels, Belgium. Yposkesi will be a gold sponsor.
• CPHI Barcelona October 24 - 26, 2023, at the Fira Barcelona Gran Via, Spain. A wide range of members from across SK pharmteco will be attending. Visit us at booth 3k70

Final Call! If you are attending, we also have a few openings remaining for an exclusive evening with members of the SK pharmteco team. The event will consist of dinner, networking, and Spanish culture. Click here to register now.

• TIDES Europe October 30-November 1, in Amsterdam, NL. Bill Dubay and Pedro Couto Rosado are attending.
• Bio Europe Live November 6–8, 2023, at the Trade Fair Center, Munich, Germany.
• Biomanufacturing World Summit??November 14–16, 2023, at the Hilton San Diego Bayfront, 1 Park Boulevard, San Diego, California.

Thank you for your previous interest in services and content from AMPAC Analytical. Should you have any questions, please get in touch with us.

Thank you for reading!