Search results for " low pH"
Article
The Importance of Partnering for Bioanalytical Studies
The Importance of Partnering for Bioanalytical Studies
Yakobchuk Olena/Stock.Adobe.com
Bioanalytical studies are an important aspect of biologic drug development that may necessitate…
Article
Improving Lentiviral Vector Downstream Processing Workflows
Lentiviral vectors (LVV) are a common vehicle to deliver genetic material in chimeric antigen receptor (CAR) T-cell therapy and gene therapy applications. Production methods have been developed by a…
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
The Evolving Role of Starting Materials in Cell and Gene Therapy
Accelerated approval pathways and growing demand for cell and gene therapies are putting pressure on providers of cellular starting m…
Article
Biosimilar Quality Requirements
This article reviews FDA’s recent efforts to streamline the biosimilar approval process and address quality concerns with the publication of new guidelines that suggest resources to aid in the biosi…
Article
Best Practices for Selecting a Top-Quality Cell Line
Irina Shi - Stock.Adobe.com
Leveraging automation and a step-by-step approach are keys to success.
By Cynthia A. Challener
Cell lines determine the performanc…
Article
Methods Accelerate Biosimilar Analysis
Methods Accelerate Biosimilar Analysis
Effective application of mass-spectrometry tools can optimize biosimilar analysis, reducing development time and cost.
By Mario DiPaola, …
Article
Advances in Engineering of Protein-Based APIs
Advances in Engineering of Protein-Based APIs
New platform technologies, advanced modeling tools, and addressing patient needs are important developments.
By Cynthia A. Challener
…
Article
Supply Chain Challenges for Single-Use Systems
Suppliers address the complexity of supplying disposable components to the global biopharmaceutical manufacturing industry.
By Jennifer Markarian
The implementation of sing…
Article
Biopharmaceutical Process Development: 2018 Lessons and 2019 Predictions
The biopharmaceutical industry continues to expand in new and exciting ways. What might be in store for 2019, and what important lessons should process developers take from 2018? Here, we look back …
Article
A Look at the Affinity Chromatography Landscape
A Look at the Affinity Chromatography Landscape
New ligands are being developed to meet the separation and purification needs of next-gen biologics.
By Cynthia A. Challener
…