08.09.24 -- Scale And Sustainability In Single-Use Systems

Examine the steps of cleaning validation for both low-volume and high-volume manufacturers and the important role these studies play.

Join us for an insightful webinar where we explore the transformative power of Digital Twin technology in modern facility management

Learn what questions to ask when developing a sterilization method and the critical tool that can help guide your decisions.

Learn how you can obtain comprehensive solutions for cleanroom projects that help you ensure regulatory compliance and operational efficiency.

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.

No two journeys through the drug pipeline are the same; the ability to leverage a variety of approaches for different products is what sets one lean biotech company apart.

Developers often aim to cut expenses during development. Discover the long-term outcomes of cost-effective measures like using RUO leukopaks compared to investing in high-quality GMP-grade vectors.

Learn about three key thermal analysis methods for fast and effective characterization and quality control: differential scanning calorimetry, thermogravimetric analysis, and sorption analysis.

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 lifecycle.

In Best Practices for Outsourcing Process Development, a panel of experts discussed four themes that may help drive the best outcomes when vetting process development service providers.

How do new mass photometers, featuring a new titer estimation tool, perform as a powerful analysis technique when used to evaluate the quality of AAV samples.

For biopharmas looking to outsource their early phase development, consider working with a CDMO partner that has the knowledge and experience to navigate microbial fermentation and complex process development.

Reduced the risk of contamination caused by repeated handling of the culture during transient protein production in suspension CHO cells.

Examine a platform process that is emerging as a simplified and reliable solution for ADC manufacturing, offering efficient process development, purification techniques, and optimization strategies.

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.

Optimize your technical transfer process using built-for-purpose, cloud-connected systems and obtain results that translate effectively to other facilities.

In the biopharmaceutical development world, Quality by Design cuts risk, streamlines processes, and speeds up regulatory approval.

Dr. Anne-Grethe Reichelt, International Sales and BD Manager at Bio-Me, discusses the current landscape of microbiome research, gaps in microbiome analysis, and the exciting possibilities ahead.

Review case studies and explore the complexities of oligonucleotide design, GMP standards for ADCs, and how developability can play a significant role in selecting ADC leads with high potential.

When choosing between protein expression formats such as transient versus stable pools, considerations include speed, cost, titre, and product quality.

mRNA therapeutics have the potential to address a variety of diseases, and understanding mRNA molecules and access faster analytical solutions are crucial elements for the rapid development of these therapies.

Delve into the importance of delivery success in gene editing and review the use of viral vectors and lipid nanoparticles as two approaches to improve this aspect.