Search results for " equipment"
Article
Impurity Testing of Biologic Drug Products
Validation of the method will then serve to confirm the robustness of these elements and assess the variability introduced by different analysts and equipment.
Both the number of replicat…
Article
Bioburden Entry Points in Downstream Processing
If you work in bioprocessing, you are no doubt aware of the need to prevent bioburden entry and proliferation, and reduce the complexity of the equipment and processes involved. Anastasia Lolas, for…
Article
Reliability Rooms and the Move to Proactive Supply Chain Management
The RRs solve challenges and problems every day, ranging from missed deliveries from suppliers to accommodating changes in demand to equipment improvements.
One of the issues monitored has been…
Article
Roadmap Leads to Innovative Biomanufacturing Strategies
While this is not a new idea, particularly around single-use equipment and components and in data structures and automation, there is a greater recognition and agreement that these areas should be add…
Article
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Novartis scientists explained how each batch of patient tissue is handled in dedicated equipment, materials, and personnel in an enrichment process to obtain a highly pure T-cell population and to ens…
Article
Best Practices for Data Integrity
Best Practices for Data Integrity
Optimize practices and meet requirements using electronic data integrity systems.
By Jennifer Markarian
Maintainin…
Article
Contract Manufacturing Through the Years
Global bio/pharma companies have made more than $125 billion in capital expenditures for new plant and equipment in the past six years, much of it to support their biologics pipelines. Outsourcing of …
Article
The New World of Biopharmaceutical Manufacturing
Industry experts discuss the single-use revolution and changes to upstream and downstream processing equipment.
By Jennifer Markarian
…
Article
From Darwin to Recombinant Fc Multimers
R&D staff were then providing scientific support during equipment and process qualification, were involved in engineering batches to monitor manufacturing performance, and also contributed to the proc…
Poster
Case Study: Improve Process Economy by Cycling of Prepacked Chromatography Columns
As projects are scaling up to manufacturing scale, it becomes attractive to cycle equipment for specific campaigns for full capture of process economy gains. This customer case study evaluates proce…