INSIGHTS ON CELL & GENE OUTSOURCING ISSUES

• Pluripotent Stem Cell Expansion And Scale-Up

  Upstream process development is complex for stem cell therapies, because these therapies involve many manipulations during cell differentiation or even cell engineering. Decisions made early in research will impact the entire product life cycle, so it is important to consider a good process design early on.

• Improving Lentiviral Vector Downstream Processing Workflows

  Lentiviral vectors (LVV) are a common vehicle to deliver genetic material in CAR T cell therapy and gene therapy applications. Production methods have been developed by adapting technologies from the bioprocessing sector. However, these downstream workflows are long, require substantial manual labor, and suffer from low yields of infectious virus. In this article we discuss process development pain points of a modern workflow and ways to address them.

• The Role Of CDMOs In Cell And Gene Therapy Process Development

  Even for experienced teams, it can be tricky to balance the efforts of reaching the first clinical trial using a manual, open method with building a more commercially suitable process. To accelerate their clinical and commercial programs, companies are choosing to work with contract development and manufacturing organizations (CDMOs). In this article, we highlight key areas where CDMOs can help companies get started in the world of CGT manufacturing. We also discuss when to engage with CDMOs to maximize commercial and clinical success.

• Smooth Transition: What Specialty Drug Manufacturers Should Know About Bridging The Gap From Clinical-To-Commercial Packaging

  As a steady stream of specialty drugs enter the marketplace, pharmaceutical companies are seeking new supply chain solutions to ensure that an uninterrupted supply of these breakthrough treatments reach patients. One solution for the challenges of packaging specialty products is low- or small-volume commercial packaging. This e-book examines the impact of specialty products and the packaging challenges associated with them. It also addresses the benefits of small-volume commercial packaging and offers recommendations about choosing a supply chain partner for this service.

• Biosimilars: Top 4 Differences When Managing Clinical Trial Supplies

  At first glance, planning a clinical supply chain for a biosimilar trial appears like getting ready for a traditional study. As in all clinical trials the supplies team is responsible for making sure the investigational biosimilar drug makes it to the right patient, at the right time and place. Yet these studies do present some unique challenges for clinical supply chain professionals. This eBook outlines the top 4 differences in managing clinical supplies for biosimilar trials. These challenges make biosimilar studies anything but routine for clinical supply teams.

• Radiance® Label-Free Monitoring Of AAV Transfection In HEK293 Cells Using Laser Force Cytology™

  There are several challenges related to the development and manufacturing of AAV-based processes, including characterization, quantification, and downstream purification. LumaCyte’s Radiance® instrument, which uses Laser Force Cytology™ (LFC) to measure the intrinsic biophysical and biochemical properties of single cells, has the potential to improve the characterization of cell-based AAV transfection and production, improving the efficiency and accuracy of both processes and shortening development time.

• Allogeneic T-Cell Therapies: Efficient Commercial Manufacturing Readiness Using “Manufacturing By Design” Methodology

  Contract development and manufacturing organizations need to play a critical role in the scale-up and industrialization of cellular therapies by providing customized  tools and processes. The Manufacturing by Design approach for addressing the industrialization of cell therapies allows for optimal production conditions.

• Scaling Up Your Viral Vector Therapy

  Early in the development of viral vector gene therapies, it’s critical to design a strategy that supports commercial needs based on clinical indication, patient population size and dosing requirements. This video reveals the most important factors to consider when scaling up.

• Viral Vector Services Regulatory Offering Menu

  The regulatory environment for Cell and Gene Therapies is evolving at a rapid pace. Many companies, especially new and emerging ones, often lack the internal resources, or expertise to support regulatory filings. Companies need a partner who continuously monitors the changing regulations and has the capabilities to support them with their regulatory needs. Patheon Viral Vector Services provides a comprehensive range of regulatory consulting services for the cell and gene therapy innovators.

• Fill/Finish Services For Viral Vectors

  We offer services for new and emerging, mid-size, and large biopharmaceutical companies and research institutions developing viral vectors and viral vaccines who need Fill / Finish capacity. Our solutions are flexible, comprehensive Fill / Finish services for viral vectors that comply with current regulatory and quality requirements.