CMOs and CDMOs Adjust to Pandemic Response and Beyond
Investments, biologics, and the impact of COVID-19 will continue to shape the bio/pharmaceutical outsourcing industry for the near term.
Data Integrity Considerations for Vendor-Generated Data Associated with Analytical Testing
Sponsors should consider best practices for maintaining data generated during sample analysis and instrument maintenance.
Preparing for the Unexpected: E&L Studies in Biopharma
New challenges arise in extractable and leachable studies for cell and gene therapy products.
Picking the Perfect Method Development Partner
There are some key questions that should be asked by both the sponsor company and the outsourcing partner before undertaking a method development project.
Integrated Approach Facilitates Inhalation Drug Development
The choice of delivery platform for inhaled drug products is contingent on API-related factors, as well as the development stage of the product.
Packaging for Stability Studies: to Outsource or Not?
Developers might invest in small-scale equipment to produce packaging for stability studies in-house, or they might outsource production. Manufacturers should consider the benefits and risks to both approaches.
Pharma Services Sector Poised for Continued Growth and Consolidation
The CRO market will see greater consolidation by both financial buyers looking to consolidate smaller players and larger CRO players wanting to expand into value-added specialty service areas.