Newsletter | July 23, 2024

07.23.24 -- More Case Studies: Managing Change In Vaccine Production

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Webinar: Transforming Safety in CDMO Operations: A Customer Centric Model for Patients and Employees

Save the date for August 5th for Transforming Safety in CDMO Operations: A Customer Centric Model for Patients and Employees. This webinar will highlight the unique infrastructure FDB has built around safety operations and quality, with a focus on their new product introduction process with respect to risk assessment. Click here to learn more.

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More Case Studies: Managing Change In Vaccine Production

Part two of this series digs into real-world examples from Sanofi for getting the right stakeholders on board when altering a process or changing equipment.

Nanoscale Technology's Potential: A Fireside Chat With Industry Leaders

Nanoform CEO Edward Haeggstrom and Shawn Davies, head of drug delivery, biopharmaceuticals development, AstraZeneca, discuss the potential of nanoscale medicines and delivery devices.

Commercial Vs. Technical Priorities: The PM High-Wire Act

PMs must be technically adept enough to understand a project, but their main role is to ensure it delivers in terms of scope and budget.

Keys To A Successful cGMP Manufacturing Operation Delivering CGTs

Uncover the secrets behind successes in commercializing and producing commercial cell and gene therapies, including establishing standards of every day, manufacturing operational excellence.

Building The Next Therapeutic Modality With End-To-End Product Support

Extracellular vesicles hold immense potential for treating diseases, owing to their natural biocompatibility and ability to carry a diverse arsenal of therapeutic molecules.

Tackling Cell And Gene Therapy Manufacturing Challenges

Allogeneic therapies are gaining popularity due to diversity, scalability, and affordability. A partner with innovative solutions can help streamline the path from discovery to commercialization.

What To Expect From Your First CMO Remote Audit

Choosing the right manufacturing partner means going beyond just technical specs. Viewing the facility layouts and conditions is critical. Now is the time to familiarize yourself with remote auditing.

Mitigating Nitrosamine Risks In Pharmaceuticals

Nitrosamines can come from a range of sources, including raw materials, manufacturing processes, and even water sources. Detecting them requires sensitive analytical methods.

Reducing Commercial Manufacturing Risks

For any biotherapeutic in development today, a critical element in achieving commercialization is reducing manufacturing risk.

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Connect with researchers from around the world for a deep dive into solutions for optimizing bioprocessing, and immerse yourself at the forefront of innovation at CHI's Bioprocessing Summit. Leaders from top pharma, biotech, academic, and governmental institutions will convene on August 19-22 in Boston and online for cutting-edge presentations, live breakout groups, poster sessions, collaboration, networking, and more. Learn more at BioprocessingSummit.com.

OUTSOURCING SOLUTIONS

Capacity Update May 2024: Large Molecule Development - JOINN Biologics

Minimizing Uncertainty Throughout The Development Lifecycle - West Pharmaceutical Services, Inc.

Combining Scientific Knowledge And Advanced Technology - Mabion

Capacity Update May 2024: Cell & Gene Therapy - Theragent

Emulate Contract Research Services - Emulate

Codex HiCap RNA Polymerase - Aldevron

Plasmid Manufacturing - Ajinomoto Bio-Pharma Services

cGMP Manufacturing - Microbial System - EirGenix Inc.

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Complex protein-based therapies don’t play by the same process-engineering rules as small molecules and traditional biologics. They require developers to see the unforeseen and embrace new roles and responsibilities in sourcing raw materials and outsourced expertise. Successful developers can’t let this winding road slow their time to IND. Join Bioprocess Online Live on August 8th for an interactive discussion on early workflow considerations for complex protein-based therapeutics. Supported by Thermo Fisher Scientific.

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