07.26.24 -- Navigating ADC Manufacturing Complexity

Discover how building a product development program with a long-term vision and adopting a holistic PPQ and CPV strategy from the outset are now crucial.

ICH Q14 provides comprehensive guidance on analytical procedure development, offering an invaluable framework for ensuring the development of regulatorily compliant analytical procedures.

Discover how and analytical QbD approach ensures that analytical methods are not only effective but resilient to variations, ultimately enhancing the reliability and accuracy of the data generated.

As the landscape of CAR T-cell therapies evolves, these treatments are becoming more precise in targeting cancer cells and overcoming production challenges, and are poised to revolutionize oncology.

Explore how Prometheus Panta was used to assess multiple developability characteristics in Merck's mAb therapeutics and to gain deeper insight into the quality attributes of their candidates.

Venkata Indurthi, Ph.D., shares his knowledge and experience with manufacturing RNA, including insight into RNA delivery and the applications–present and future–that innovations in the field are enabling.

Learn about the problem of immunogenicity of mRNA, modified mRNA via in vitro transcription production, and choosing fit-for-purpose modified ribonucleotides.

Explore how ADC chemistry and manufacturing have evolved, the challenges this dynamic growth has created, and how CDMOs are adapting to these changes to meet customer needs, now and in the future.

Delve into the intricacies of creating robust cell lines for monoclonal antibody production, as well as process development principles key for achieving therapeutic success.

Examine a platform process emerging as a simplified and reliable solution for developing ADC manufacturing processes, enabling accelerated preclinical and clinical development.

To aid in the manufacturing of new vaccines, Pichia pastoris yeast, a promising protein expression system, could be the perfect solution.

A CDMO’s manufacturing science and technology (MSAT) plays a critical role in optimizing a biomanufacturing process to meet the needs of the modern healthcare landscape.

Delve into the intricate workflow employed for the discovery and characterization of monoclonal antibodies (mAbs) targeting the Delta spike protein.

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.

Researchers working with PNP's to provide efficient and targeted treatments are facing challenges with scaling-up manufacturing and production.

This poster reviews studies for three monoclonal antibody drug candidates utilizing a panel of small scale, fast, and predictive tests used to evaluate therapeutic antibodies’ developability.

Explore the benefits of the XS® Pichia 2.0, including speed, simple fermentation regimes, and robust, scalable processes that can be tuned according to the specific objectives of a program.

The unique challenges of a viral vector asset or molecule require high-throughput processes and analytical development solutions, coupled with extensive industry experience.

Depending on the protein or peptide of interest for your therapeutic and your manufacturing goals, there a number of different manufacturing approaches, each of which can be advantageous.

Explore five key areas in oligonucleotide chemistry where improvements will have a huge influence on your synthesis quality.

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

Gain insight into the importance of scalability for future clinical products made from extracellular vesicles, the quality of peer-reviewed extracellular vesicle/exosome science, and more.

Acquire a thorough understanding of environmental monitoring, covering the fundamentals of particle counting and cleanroom designs, regulatory expectations regarding market release, and more.

Modular cleanrooms are both intricately engineered, high-performance machines and durable, working facility structures. Learn how they are compatible with your manufacturing process now and in the future.

Disinfectant efficacy studies are crucial for safeguarding the sterility of your manufacturing facilities. In this whitepaper, experts review intricacies and how to design this important study.

Explore the importance of biological indicators and why they should be an integral part of any comprehensive sterilization program.

Process optimization is key to achieving effective pharmaceutical and cosmetic critical cleaning. Learn how manufacturers can improve cleaning efficiency and ensure product safety.

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.