INSIGHTS ON CELL & GENE MANUFACTURING
Robust Harvest Clarification For Adeno-Associated Viral Vectors Via Depth Filtration
This article demonstrates that depth filters clarify AAV vectors, helping to overcome the unique separation challenges presented by these important vectors for gene therapy.
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.
Risk Mitigation For Single-Use Cold Chain Distribution
In this recorded webinar, we will share risk mitigation study data showing the utility of low temperature suitable materials and packaging, employment of sensors for monitoring shipments, and better qualification and evaluation through simulated standards and real-world transit.
Rapid Design-Build Cleanroom Solutions: AES Fast-Lane Program
Speed-to-market is the number one driver in the pharma/bio industry today ... the faster our clients can build facilities, the quicker they can get treatments into the hands of the patients who need them the most. The AES Fast Lane program is an accelerated Design, Manufacture, and Installation program that fast tracks your cleanroom facility project in seven months.
Single-Use Fluoropolymer Bags For Efficient High-Density Cell Banking
The need for rapid development and scale-up of vaccines and therapeutics has never been greater. But conventional seed train processes used to amplify cells from cell cultures are inefficient and subject to risk. This white paper explains how single-use bags perform during freezing, storage, and thawing steps and why they present an efficient alternative to vials in a variety of upstream cell banking applications.
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.
Traditional Sensors And Single-Use Systems: Bridging The Connectivity Gap
The secure, leak-free connection of sensors to single-use assemblies is paramount in ensuring both the accuracy of the measurements taken and protection of the manufacture of expensive drug products.
Establishing Process Data Visibility In Contract Manufacturing Networks
This joint webinar with Accenture explores the key findings from Accenture’s ‘Dare to be Different’ industry survey including the challenges within today’s increasingly decentralized and complex supply chain and how sponsors and CDMOs plan to address them.
Business And Legal Risks In Life Science Outsourcing
Significant business and legal risks threaten emerging and global life science enterprises. Among those are the industry's extensive reliance on external partners for product development and CDMOs.