Newsletter | July 8, 2024

07.08.24 -- Genderless? Gendered? Single-Use Standards?

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A ballooning clinical-stage ADC development community is putting stress on both manufacturing capacity and antibody engineering and conjugation talent. What does this burgeon mean for ADC manufacturing, process development, and, ultimately, clinical progress? Join Bioprocess Online Live on July 9th as we navigate the complexity of the ADC manufacturing environment. From linkers to payloads to conjugation, we’ll cover the lay of the land for developers. Registration is free thanks to the support of Cytiva.

FOCUS ON UPSTREAM MANUFACTURING

Genderless? Gendered? Single-Use Standards?

Mark Petrich, VP of Technical Operations, Krystal Biotech, and single-use consultant and guru Paul Priebe take audience questions on connectors and industry standards.

Control Stem Cell Growth And Differentiation With Small Molecules

Dive into the role of small molecules in stem cell research, regulating stem cell proliferation, and their function as determined by the specific key signaling pathways they interact with. 

Development And Optimization Of Suspension-Adapted 293T Cell Line

Learn how an adapted cell line can reduce costs and improve scalability in the production of lentiviral vectors for CGTs and examine its potential to produce GMP-grade lentiviral vectors.

A Flexible Approach To CMC For Fab And Fc-Fusion Development Programs

Characterizing Fab and Fc-Fusion proteins and developing robust manufacturing processes can help usher them to market and provide new treatment options for diseases that are challenging to treat.

The Advantages Of Single-Use Bioreactors

Reduce the time and risks involved in maintaining a traditional bioreactor with this single-use solution for biopharmaceutical manufacturers.

Continuous Monitoring And Control Of Glucose And Lactate

This experiment demonstrates that continuous real-time monitoring of glucose and lactate and dynamic glucose feed control to a low-level set-point leads to improved process and product parameters.

Accelerate Cell Expansion And Sustain Viability With A Serum-Free Medium

Explore the results of a study comparing Sf9 insect cell growth in three different mediums.

Optimizing Perfusion Parameters Using Quality By Design

In this study, the optimization of perfusion parameters to maximize CAR-T cell growth and quality within a single-use, automated stirred-tank bioreactor is systematically investigated.

Rapid Generation Of Bulk-Selected CHO Pools

Traditional cell line development is extremely time-consuming, taking up to six months and delaying the runway to clinical trials. However, innovative transposase technology offers a fast and robust alternative.

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Register by 17 July to Save up to 20%

The PDA/FDA Joint Regulatory Conference 2024, the only FDA co-sponsored pharmaceutical CGMP conference, is taking place 9 to 11 September in Washington, D.C. Now in its 33rd year, the conference will offer a comprehensive agenda with substantive technical sessions and practical case studies that provide insight into the effective application of Current Good Manufacturing Practice (CGMP).

UPSTREAM MANUFACTURING SOLUTIONS

Single-Use Manifold Kits: Streamline Upstream Processing - Entegris, Inc.

CHEF1 Expression Technology - AGC Biologics

Bench-Top Bioreactor For Solid Substrates And Enzymatic Bioprocesses - INFORS HT

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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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