Newsletter | August 5, 2024

08.05.24 -- Temperature & Containment Controls In ADC Manufacturing

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Webinar: Accelerating mAb Process Development in the Growing Therapeutics Market

Join us on August 20th as Thermo Fisher Scientific scientists explore the latest strategies and advancements in early stage mAb up- and downstream process development. They will share valuable insight on stable CHO cell line development for mAb production, media and feed screening strategies to meet clone specific nutritional needs, and techniques to enhance purification process development by high-throughput screening. Click here to learn more.

FOCUS ON UPSTREAM MANUFACTURING

Temperature & Containment Controls In ADC Manufacturing

During a Bioprocess Online Live discussion with leaders from a couple of biotechs with Phase 1 ADC assets in the clinic, an audience member asked questions about OEB (occupational exposure bands) and managing the elevated temperatures required of ADC conjugation. We couldn't address them on the call, but here are some resources that might be helpful.

Bispecific Antibodies Unleashed

Explore how leveraging expert CDMO partnerships can streamline the development process and enhance the efficacy of your bispecific antibody therapies.

Simulated Control Strategy For Product Diversion Management

Explore a manufacturing platform that integrates perfusion bioreactor technology; continuous product capture, low pH viral inactivation, and polishing steps; viral filtration, and formulation steps.

Striking A Balance Of Speed And Quality To Deliver Next-Gen Therapeutics

Successful delivery of a bispecific antibody therapeutic to patients necessitates a manufacturing strategy that can accommodate the unique size, structure, and complexity of these molecules to ensure quality.

Addressing The Challenge Of Scalability In Viral Vectors

Learn more about a wide range of solutions to facilitate the delivery of gene therapy by addressing the challenges related to viral vector manufacture and scale-up.

Enhanced T Cell Expansion While Maintaining Early Memory Cell Phenotype

Study the development and performance of this animal origin-free (AOF) T cell culture medium designed for T cell expansion through an experiment comparing it to other AOF or xeno-free basal offerings.

A New Approach To Addressing The Issue Of Genomic Stability In iPSCs

Watch to explore the various types of quality control necessary for iPSCs, and gain insight into the latest advancements in iPSC culture and quality control.

Determining The Power Numbers For A Single-Use Mixing System

In designing a mixing process for scale-up, the power number is a critical parameter. Explore the determined power numbers for a single-use mixer at various mixing speeds and fill levels.

Accelerate To IND: AAV Transient Transfection, Producer Cell Line Platforms

The streamlined AAV transient transfection platform de-risks your path to IND and reduces complexity and timeline for lengthy process and analytical development.

Harnessing mRNA As A Readout To Develop Robust BioPotency Assays

Discover a new potency bioassay using RT-qPCR to assess relative transcription activity, and learn more about the advantages and limitations of transcriptional assays versus reporter gene assays.

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AI and machine learning are the buzzwords of the decade, often accompanied by lofty promises — but what do they really mean for biopharma? How can these technologies be adopted to improve biomanufacturing processes, testing, and quality? Join Bioprocess Online Live for an exploration into the practical applications of AI/ML in biomanufacturing, its barriers to adoption, and how regulators can help standardize use across the industry. Registration is free thanks to the support of Atum Bio.

UPSTREAM MANUFACTURING SOLUTIONS

Cell Line Development Solutions - ATUM

High Performance, Reliable, And Flexible Bioreactors - Cytiva

Krakatoa Benchtop Media Maker - Nucleus Biologics

Quantum Flex Cell Expansion System - Terumo BCT

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Webinar: Streamlining Cell Culture Media Manufacturing

Join us August 15th with Thermo Fisher Scientific as we address effective ways to accelerate cell culture media manufacturing, including rapid, small-scale non-CGMP media prototyping and outsourcing options to ensure an uninterrupted supply of your cell culture media raw materials. We will share ways to improve quality, simplify technology transfer of proprietary media formulations, and mitigate logistical challenges associated with custom media scale-up processes. Click here to learn more.

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