Newsletter | March 18, 2024

03.18.24 -- Relational Risk Analysis For The Bio/Pharma Industry

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In this presentation from the February 2024 OPCU event, Mabion, a biologics CDMO with end-to-end services focusing on recombinant proteins development and production, showcases their new installations in upstream development, bioreactors, and downstream development and fill finish. This state-of-the-art EU-GMP-certified facility is staffed by a team of 250 professionals and as of 2023 is focused solely on providing CDMO services to its clients. Watch now.

FEATURED EDITORIAL

Relational Risk Analysis For The Bio/Pharma Industry

Developing and manufacturing biopharmaceuticals depends on managing a wide variety of risks. This article presents an alternative risk analysis approach for efficiently modeling any risk.

Strategic Deals with CinRx's Gavin Samuels, M.D.

Gavin Samuels, M.D. found his work as an intensive care physician boring. He left the hospital and entered biopharma, then made a biz dev name for himself at places like Merck, Pfizer, Quark Pharma, and Teva. He shared insight from the journey, and his latest work at CinRx, on this episode of the Business of Biotech. 

INDUSTRY INSIGHTS

Quality Implications Of CO2 Sensing In Bioreactor Applications

Examine the technologies underpinning the current sensors being utilized in dissolved CO2 measurement devices and determine which sensors are appropriate for your application.

Fundamentals For Bispecific Antibody-Based Cell Line Development

BsAbs’ dual specificity opens a wide range of applications. Understand why consistent production of structurally complex molecules that exhibit high yield and purity requires keen expertise and experience.

What You Paste Matters

Explore the use of transposase/transposon systems in the biotech industry, particularly in the development of stable cell lines for protein manufacturing.

Bioreactor Scaling Made Simpler

Gain insight into how digital standardized tools can streamline your scaling processes and enable more accurate prediction and visualization of your scaling needs.

Process Validation: A Critical Step In A Biopharma Product's Life Cycle

Process validation is a critical step in the successful commercialization of a new biopharmaceutical. Learn about the challenges and the importance of applying it throughout the entire product life cycle.

A Novel Platform For icIEF Fractionation Of Antibody Charge Variants

Learn about an icIEF-based fractionation platform that can be used to collect protein variants and enable downstream analysis of the variants with techniques such as mass spectrometry.

Identification Of Downstream Host Cell Protein Impurities

This discussion on orthogonal methods, such as immunoaffinity chromatography and mass spectrometry, provides a deeper understanding of HCPs that impact patient safety and drug stability.

Overcome Complex Protein Challenges With Optimized Expression

Realizing the potential of next-generation molecules calls on appropriate expression technologies and development processes that can facilitate their path to market.

Manual vs. Automated Labware Washing

Compare manually washed labware and labware cleaned in automatic washing systems to see how the challenges of manual washing can impact your lab's efficacy and repeatability.

Process Improvements And Alternate Sources Of Chromatography Resins

Learn about different regulatory pathways manufacturers have taken for introducing biopharmaceutical process improvements and alternate sources of chromatography resins.

Key Considerations For Phase 2 Clinical Injectable Drug Manufacturing

Why are scalability and flexibility so important when choosing an early-stage manufacturing strategy, and how does that decision impact financial outcomes for a drug development program?

Develop And Commercialize Efficient And Effective PEGylation Processes

The future of conjugation and PEGylation in biologics is promising. Understand the key focus areas for PEGylated proteins.

In Focus: The C Of CDMO

Delve into the intricacies of a successful CDMO relationship and learn how a collaborative approach built on shared goals and open communication can maximize the potential of your cell therapy program.

Characterizing The Effector Functions Of Therapeutic Antibodies

Understanding the Fc region of your antibody is crucial for assessing the impact on immunology, safety, and efficacy. Explore how to determine the most efficient way to test functionality.

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Webinar: The Increasing Demand For Sterile Filtration Of High Concentration Drugs

Industry experts share the current trends and challenges associated with the manufacture of high-concentration drug products and provide an overview of their preferred approach to perform extensive filterability trials without the need to generate a high quantity of expensive product. Click here to learn more.

SOLUTIONS

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Plasmid Production: Utilizing An Integrated Project Teams Approach

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Takeone Flex Aseptic Sampling Solutions

Measure The Size And Concentration Of Nanoparticles In One Drop

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