Investigating Outsourcing
Broader industry shifts may lead outsourcing companies to prioritize integrated services.
Balancing AAVs Versus LLVs
Burgeoning CGT modalities bring promise and challenges.
A Look into Biologic Scale-Up Strategies
Scale-up strategies for cell culture will require a deep understanding of overall bioprocess workflows.
Streamlining Downstream Processes
Process automation technologies aid modernization and enable closed systems.
Challenges to Cell Expansion for Allogenic Cell Therapies
Sourcing of donor cells, access to fit-for-purpose reagents and manufacturing systems, and scalability are top issues.
Dealing with Data: How to Keep It Manageable
Advanced analytical tools generate more data in today’s labs than ever before.
The United States and the Global BioPharma Market
Context surrounding the Inflation Reduction Act is necessary for a comprehensive understanding of the global biopharma market.
Staffing Shortages: Major Hurdle for Bioprocess Contract Manufacturing Services in 2023
More than a third of CMOs are struggling to keep skilled technical and production staff.
Industry Challenges Medicare Price Negotiation Scheme
Manufacturer lawsuits prompt CMS to [slightly] modify pricing plan.
Supply Chain Securities
A proposed database includes key information about critical drugs, such as the country of origin and quantity, so supply chain weaknesses can be identified.
New Magic from mRNA
mRNA may be a modality whose chief advances are yet to come.
Sharing Critical Information for the Best Outcome
The more information shared, the smoother the approval process, says Susan J. Schniepp, distinguished fellow with Regulatory Compliance Associates.
