Biosimilar Manufacturing solution center
-
AI Performance Management In Biologic And Drug Development
3/7/2025
Life cycle maintenance is essential in AI-driven drug development. Regulators recommend continuous updates to AI models to monitor and adjust for data pattern changes.
-
Outsourcing RNA-LNP Production: A Key To Competitive Success
3/6/2025
Manufacturing RNA-containing LNPs demands specialized expertise. Explore some of the challenges of RNA-LNP drug manufacturing and the advantages of outsourcing RNA-LNP formulations.
-
Addressing Challenges In Automated Visual Inspection Of Lyophilized Vials
3/4/2025
Manual inspection is inefficient. Automated systems can struggle with the variability of lyo cake structures. Key technological advancements are coming to the forefront to address these issues.
-
How To Build Resilience Amid Dynamic Biopharma Vendor Relationships
3/4/2025
The key to effective vendor management lies in understanding how relationships derail in the first place. Here are some common reasons and tips on how to avoid them.
-
What FDA Draft Guidance Tells Us About In-Process Control Strategies
2/28/2025
The draft aims to modernize the regulations in 21 CFR 211.110 catching up to progress in the field including advanced manufacturing and analytical technologies.
-
Pharma 4.0 Adoption Needs Cooperation — Here's How To Build It
2/27/2025
A recent survey by the International Society for Pharmaceutical Engineering found that an inadequate company culture raised the greatest barrier to digital maturity.
-
Deciphering FDA's 7-Step Framework For AI-Driven Decision-Making
2/27/2025
The draft framework, published in January, aims to ensure that AI systems used in drug development are robust, reliable, and aligned with regulatory expectations.
-
Biologics Technology Transfer Guidebook
2/26/2025
Explore why technology transfer is a critical component in mammalian biologic drug development and manufacturing with the essential guide to biologics tech transfer that covers key strategies, best practices, and critical considerations.
-
How To Optimize Downstream Separation With Tagless Proteins
2/26/2025
The intein-based magnetic bead system enables effective affinity capture, tag removal, and buffer exchange, supporting direct analytical applications.
-
mRNA Vaccines And Therapeutics: Current Trends And Perspectives
2/25/2025
Delve into the advancements and transformative impact of mRNA vaccine technology on modern medicine and explore how this technology is revolutionizing healthcare for the future and beyond.