02.19.24 -- To Thrive In A Highly Regulated Manufacturing Environment, Improve Your Flexibility

The presence of antidrug antibodies can affect the safety of biologic drugs. Read why regulatory agencies emphasize the need for extensive immunogenicity evaluation in biosimilar development.

Learn how controlling freezing rates by using specialized vials and employing optimized stoppering techniques can reduce the risk of vial breakage during lyophilization and ensure high product quality.

Establishing a chemistry, manufacturing, and controls strategy that proves a clinical program is tightly controlled and can address risk is critical to avoiding the pitfalls that stall many promising therapeutics.

Explore the field of magneto-optics, along with why the manufacturing of magneto-optic materials is crucial for experimental and practical laser applications and for detecting magnetic field strength.

The biopharmaceutical industry is trending toward building process characterization systems and processes early in a project’s life cycle, enabling success for later-stage development.

Determining the best single-use systems to implement in a given manufacturing operation requires a thorough understanding of both the process specifications and the capabilities of the component.

Hear from some of the experts who were instrumental in developing the accelerated mAb development program and work with biotech companies on a daily basis to accelerate their production timelines.

Learn about tools to optimize the IVT reaction for enhanced mRNA yield, along with how factors such as magnesium ion and nucleotide concentrations significantly impact that IVT reaction performance.

Investigate important considerations for working with three different stem cell types: mesenchymal stem/stromal cells, induced pluripotent stem cells, and neural stem cells.

Watch experts discuss the latest trends in antibody-drug conjugate (ADC) discovery and development and how next-generation pipelines are being shaped by payload and linker-chemistry innovations.

Learn how a recent expansion into Western Pennsylvania is aiming to enable more biopharmaceutical firms to translate cutting-edge science and research into practical applications.

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.

Examine the benefit of using fluoropolymer film bags for the handling and storage of high-value oligonucleotides-based payloads.

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.

Discover two new CLD platforms that offer cost efficiencies and provide options to de-risk the pathway to IND application, marking a significant advancement in the field of biologics development.