Newsletter | November 15, 2024

11.15.24 -- Inside J&J's Many-Indication mAb

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No matter how robust and consistent your assays are today, the time will come when a tech transfer, a scale-up, a supplier change, a partnership deal, or some other force of change requires an analytical methods transfer. You should be preparing for that day. Join Bioprocess Online Live on December 3rd for best practices to ensure the methods you're developing today are seamlessly transferrable tomorrow. Registration is free thanks to the support of BD Bioscience.

FOCUS ON PROCESS ENGINEERING

Inside J&J's Many-Indication mAb

Leona Ling, Ph.D.’s relationship with the investigational monoclonal antibody nipocalimab is defined by curiosity, perseverance, and commitment. She discovered the molecule while working for Momenta Pharmaceuticals, and she continues to shepherd it long after J&J's $6.5 billion bid for it in 2020.

Strategies For CMC Development In Biopharmaceutical Production

Discover how implementing a strategic approach to optimize the platform can establish a solid foundation for the efficient, reliable, and successful manufacturing of biopharmaceutical products.

Overcoming Efficiency And Quality Challenges In Gene Therapy Development

Review the importance of collaboration and innovation in addressing the challenges with scaling up gene therapy production, from adopting new cell lines to integrating AI in process optimization.

The Impact Of Tip-Based Systems And Jetting Technology

Discover how protein A resins with superior binding capacity and elution efficiency transform high throughput process development for mAb purification, optimizing results and reducing time to market.

Analytical Strategies To Address Common Development Challenges

Discover analytical strategies designed to address challenges occurring during development of new molecular formats such as chain assembly, multiple-MoAs, and diverse post-translational modifications.

Introduction To mRNA Manufacturing

The SARS-CoV-2 virus has changed the course of scientific research around mRNA. Learn about mRNA manufacturing, the structure of a mRNA molecule, RNase-free considerations, and more.

Validating Antibodies With Knock-Out Technologies

Watch to learn about how one company achieves antibody validation through knock-out (KO) technologies as well as the significance of gene KO technologies in the large-scale screening of antibodies.

Technology Transfer Considerations

Speed and flexibility are crucial in the development of a new drug, from the laboratory to clinical trials and ultimately to the market. Explore considerations for a successful technology transfer.

The Keys To Analytical Method Development, Qualification, And Validation

Review how following regulatory guidelines and partnering with a reliable contract biologic manufacturer ensures the highest standards are met in pharmaceutical research and quality control.

Building Better BioTherapeutics With Machine Learning, Synthetic Biology

Learn about high throughput biologic automation and GMP master cell banking services as well as variable selection services that search the SQL space to find promoters.

Streamlined Cell Therapy Development

Learn about the initial stages of product development — specifically, how to move from candidate selection to a Phase 1 Investigational New Drug (IND) application.

Transient Expression Technologies For Antibody Production

Review studies that showcase the potential of the CHOgro Expression System in early stage drug development, where high titer antibody production in suspension CHO cells is crucial.

Flexible Expression Technologies For Mammalian, Microbial Proteins

Drs. Joachim Klein and Rebecca Michael from Lonza Pharma & Biotech answer attendee questions from a recent webinar about Lonza’s options for expressing and manufacturing complex biologic drugs.

Hosts For Vaccine And Virus Expression: Insect Cell Expression Systems

Choosing the right host is key to creating scalable, robust, and reliable commercial processes. Explore common challenges associated with the insect cell culture/baculovirus expression vector systems platform.

Enhancing CMC Regulatory Efficiency In Gene Therapy

Ensure your business stays ahead in today’s complex regulatory environment by implementing robust regulatory affairs strategies that streamline compliance and product approvals.

How A Top Biotech Achieved Right-First-Time Batches

Gain insight into how a global leader in pharmaceutical manufacturing overcame significant challenges related to their ultrafiltration process.

Engaging Early In Process Development To Bring mRNA Sequences To Life

Examine why template sequence characteristics are relevant for cGMP manufacturing of high-quality mRNA and consider insights on how to develop a scalable, robust, and economically viable process.

Super Short Activated CAR-T Process

Experience the benefits of faster, more effective CAR-T cell production with this innovative three-day short-cycle process, designed to enhance patient treatment outcomes while reducing costs.

PROCESS ENGINEERING SOLUTIONS

Our Facility - VintaBio

Transfection Solution For Gram-Scale Protein Production: ExPERT VLx - MaxCyte, Inc.

Adherent HEK Cell SF Media: HEKima - Nucleus Biologics

FOCUS ON FACILITIES DESIGN

Commissioning & Qualifying: Facility Considerations For Tissue Engineering

This article provides an overview of the facility considerations for tissue engineering. It includes a comparison of a bulk biologics facility, which aids the discussion.

Labware Washing Techniques And The Sinner's Circle

Explore labware cleaning techniques, comparing manual and automated processes, and how balancing the four factors of the Sinner’s Circle ensures effective, repeatable laboratory outcomes.

Equipping A Flexible Facility: Find The Balance Between Cost And Innovation

An overview of the trend of multiproduct and flexible facilities, defining the different types of facilities, and how working with a partner is a strategic move for any company.

Design–Build Cleanroom Projects: A Proven Risk Mitigating Methodology

Learn about the rising demand for cleanrooms in the biopharmaceutical industry, factors driving cleanroom design, building in flexibility, the role of critical path assessments, and more.

Cleaning Proteins, RNA, And DNA From Laboratory Equipment

Learn about three of the best methods for cleaning proteins, RNA, and DNA from laboratory equipment.

Key Factors For Optimized Microbial Air Sampling

Learn about active air sampling and the characteristics of various microbiological sampling methods that are designed to optimize collection efficiency.

How To Prove A Sterility Assurance Level Of 10⁻⁶

Explore the Biological Indicator/Bioburden (BI/BB) method for achieving sterilization of products along with the prerequisite studies needed to develop the sterilization process.

FACILITIES DESIGN SOLUTIONS

Cell Culture 1 3D Facility Tour - Scorpius BioManufacturing

Create A Quick And Easy Closed Connection - CPC

Microbial Air Sampler: MiniCapt Mobile - Particle Measuring Systems

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