Search results for " facility"
Article
Evolving demands of process development services
…ing this a step further, having drug product formulation and manufacturing within the same or nearby facility, especially, in the case of oligos, peptides, and conjugates, having an injectable formul…
Article
Cytiva Invests $500 Million Over 5 Years to Expand Global Capacity
The manufacturing capacity of Cytiva's MabSelect and Capto chromatography product platforms has also doubled as part of a $70-million-per-year (2017–2022) investment in capacity gains and a facility m…
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
Flawed sample handling during cell collection and transfer to the manufacturing facility, however, carries a greater risk than minor process losses. Contamination risk, whether from outside sources or…
Article
New Therapies Present Scaling Challenges
Cells must first be collected from the patient, transported from patient to a manufacturing facility where the cells are processed, and then shipped back to the patient for administration. The entire …
Article
Monitoring and Control of Inline Dilution Processes
“Automated buffer preparation methods can lead to a more efficient use of existing resources, including labor and consumable savings, and smaller facility footprints. Eventually, by getting more out f…
Article
Science Focus Fuels Successful Process Development for Startups
“We built a GMP facility to manufacture the products entirely in-house, so process development was a fundamental activity for us,” she adds.
In-house or outsource?
The decision to build its ow…
Article
The Outlook for CMO Outsourcing in 2019
By Eric Langer and Ronald A. Rader
Biopharmaceutical industry-related indicators and trends are supporting continued incremental increases in outsourcing of pre- and commercial AP…
Article
Leveraging Data for Better Biopharmaceutical Process Control
…ontinuous biopharmaceutical processes, but the industry’s existing plants have a totally different facility design. A strong business case will be needed for taking this approach before much more can…
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
The Sidebar describes a VRL case study for a biopharmaceutical facility.
Sidebar: visible residue limit case study
A large biopharmaceutical manufacturer was desi…
Article
Technical and Process Economical Aspects of Using Capto™ Q and ReadyToProcess™Adsorber Q in mAb Polishing
By minimizing the need for cleaning operations, thereby reducing the changeover time between campaigns, ReadyToProcess Adsorber membranes allow for more batches to be produced per year, improving faci…