Search results for " reliability"
Article
The Importance of Process Intensification and PAT for Achieving Real-Time Release
Given the reliability of platforms and the maturity of the industry’s understanding of quality, the most important business driver today is speed to market. One consequence of this emphasis on speed i…
Article
Updating Viral Clearance for New Biologic Modalities
Viral clearance processes and guidance must evolve along with newer biotherapeutic modalities.
By Feliza Mirasol
Ensuring viral clearance (i.e., removal) in downstream purification has becom…
Article
Reimagining Affordable Biosimilars
Advances in preclinical development play a crucial role in reducing cost for developing biosimilars.
By Anurag S. Rathore, Narendra Chirmule, and Himanshu Malani
Drug development is …
Article
Technology Innovations Improve Process Chromatography Performance
As technology matures, inefficiencies and process limitations in downstream process chromatography are improved.
By Feliza Mirasol
Selecting an appropriate separation technology fo…
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
Mechanistic Modeling of Chromatography: Opportunities and Challenges
What is mechanistic modeling in chromatography? Explore opportunities and challenges of an approach that can help make process development become faster, more scientific, and more reliable.
Cl…
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
Small donor networks are vulnerable to issues, such as unexpected drops in the number of donations, uneven reliability, and inadequate diversity to meet the specific needs of their clients. Sourcing c…
Article
Using Software in Process Validation
…uct comply with quality requirements that have already been predetermined and assure consistency and reliability (1). The regulations (21 Code of Federal Regulations [CFR] Parts 210 and 211) encompas…
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
Tools and Processes for Mature and Emerging Therapies
…mns, media, buffers, single-use systems, and ancillary equipment to promote process capabilities and reliability.
New technologies for aseptic processing—a frequent source of quality problems—wer…