INSIGHTS ON CELL & GENE OUTSOURCING ISSUES
Overcoming Challenges In AAV And LV Viral Vector Manufacturing
Learn more about the platform-based scalable suspension process for LVV production and how it is impacting CGTs advancing toward commercialization.
Establishing The Right-Sized Tech Ops Strategy In An Uncertain Market
A quantitative and qualitative tech ops strategy gives biotech companies a sound roadmap to guide them through the winding road of drug development and attract investors.
Overcoming Risk In Cell And Gene Production
To meet the speed to market demands of today requires process standardization and portability, improvements in raw material supply and sourcing and greater supply chain control.
CRISPR/Cas Nucleases Product Guide
Discover how manufacturing research grade Cas enzymes in an ISO 13485 certified facility enables a seamless transition to a cGMP product as you progress into the clinic.
Set Your Oversight Early, But Do Not Dictate All The Rules
As more and more sponsors partner with CDMOs to leverage their expertise and capabilities, utilizing the right framework to manage a partner is crucial for the relationship to function at its optimally.
From Capacity To Comparability: The Shifting Onus In Cell & Gene Therapy Outsourcing
As we continue progressing beyond the COVID (i.e., the seller’s) economy, both Haskett and Graskemper agree we’re steadily seeing biotechs taking on a much more empowered role in negotiating with and securing CDMO partners. But they also see several shifts in the CGT development landscape that could impact both biotechs and their outsourcing partners equally — for the better, or if we’re not careful, for the worse.
Moving From Clinical Stage To Commercial? 4 Steps For An Outsourcing Strategy
If you're a pre-commercial bio/pharma looking ahead to commercial stage, evaluating partnerships are faced with making key decisions around which capabilities to outsource, the degree of data access and ownership, and which external partners are the right fit. Here are four key actions to consider.
How Strategically Partnering With Academia Supports Biotech R&D Goals
For early-stage biotechs, partnering with leading academic institutions can help your firm cut costs and boost the returns on R&D investments while making key research and industry connections that can assist in the development, and ultimate commercialization, of your drug/therapy products.
A Step-By-Step Approach To Implementing Quality Infrastructure
Pharmaceutical and biotech companies can upgrade their data management platform without compromising study timelines by implementing a phased approach that gradually shifts to a better, more efficient system.
Shifting Strategy: Advanced Approaches To Plasmid Production
Explore the benefits of working with a CDMO that has extensive plasmid experience and integrated project teams across the production process.