Search results for " control" in Articles / App Notes
Article
Tools and Processes for Mature and Emerging Therapies
To control contamination threats during transfer and fill/finish steps for bulk, vial, and syringe filling, companies introduced improvements to existing technologies and processes such as restricted …
Article
Design Considerations for a Commercial Cell and Gene Therapy Facility
And then, finally, a digital solution encompassing electronic batch records, process monitoring, scheduling, and other key process attributes should be designed-in early to add efficiency and control …
Article
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Factors that need to be analyzed and controlled for biosimilar development. (Figures courtesy of the authors)
Monoclonal antibodies (mAbs) are at present the fastest growing subclass of biophar…
Article
State of the Biopharmaceutical Industry: Lessons from 2018 Survey Data
• When asked a new question about what broader pharmaceutical industry small-molecule experience could benefit the biopharmaceutical industry, the leading three responses were "Process control, real-t…
Article
FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
By Jill Wechsler
While cell- and gene-therapy products hold the promise of transforming the treatment of many diseases, difficulties in achieving consistent process control could sty…
Article
Biopharma Seeks Balance
While the business, economic, political, and regulatory perils may be difficult to predict, science and technology can give biopharma more control and predictability over drug development and manufact…
Article
Challenges in Cell Harvesting Prompt Enhancements
Coupled with head pressure applied to the bioreactor, a completely sealed system such as this allows the flow to be controlled at the outlet of the machine, which removes the need for pumps and flow-c…
Article
Automation Trend in Fill/Finish Reduces Contamination Risk
… sterilized filling components, fill/finish processes are heavily dependent on technique, equipment, controls, and having detailed procedures (1).
Handling sterile liquids in the pharmaceutical i…
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
Several published articles have evaluated the use of visual inspection procedures and the role of visible cleanliness in control of critical variables, as well as establishing visible residue limits o…
Article
Establishing Acceptance Criteria for Analytical Methods
Little, PhD
To control the consistency and quality of pharmaceutical products, analytical methods must be developed to measure critical quality attributes (CQAs) of drug substance/drug product. An…