Search results for " modeling"
Article
Addressing the Complex Nature of Downstream Processing with QbD
Quality by design brings both challenges and benefits to the development of downstream processes.
By Susan Haigney
natali_mis/Stock.Adobe.com
Regulators have been en…
Article
2019 HTPD Conference Is Announced. What Happened Last Time?
The 5th international conference devoted to high-throughput process development (HTPD) and smart PD, will take place November 4-7, 2019 in Porto, Portugal.
HTPD 2019 will cover process devel…
Article
Nurturing Knowledge from Disparate Data Streams
Each possible parameter variant requires a data point for the modeling system used to determine the optimum operating conditions.
In addition, the data itself is becoming more complex. A nuclea…
Article
A Plastic Pipeline for Commercial Bioprocessing?
A Plastic Pipeline for Commercial Bioprocessing?
The maturation of single-use technologies presents commercial bioprocessing options for small-volume drug products.
By Rita C. Peters
…
Article
Optimizing Late-Stage and Commercial Cell-Culture Processes
• Modeling and leveraging platform knowledge; extensive platform knowledge is enabling more efficient process validation as one study can support multiple products. A platform culture process also ena…
Article
CoAs Help Secure the Supply Chain
CoAs Help Secure the Supply Chain
Certificates of analysis can be used to monitor the reliability of products and their suppliers.
By Susan J. Schniepp, distinguished fellow at…
Article
Understanding Validation and Technical Transfer, Part I
Understanding Validation and Technical Transfer, Part I
This is the first of a series of three articles about validation and technical transfer in the bio-pharmaceutical industry. Part 1 || Part 2 |…
Article
Development of Purification for Challenging Fc-Fusion Proteins
Development of Purification for Challenging Fc-Fusion Proteins
This study outlines methods for an alternative protein-polishing process for challenging proteins.
…
Article
Contract Manufacturing Through the Years
Contract Manufacturing Through the YearsHow has the bio/pharmaceutical contract manufacturing industry evolved over the years and what does the future hoHow has the bio/pharmaceutical contract ma…
Article
Reconciling Sensor Communication Gaps
With those changes, process modeling to ensure product quality and smooth operation becomes crucial. Quality by design and its enablers—process analytics and advanced control strategies—move to the fr…