Search results for "validation"
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Haury, “Applications of Failure Modes and Effects Analysis to Biotechnology Manufacturing Processes” in Process Validation in Manufacturing of Biopharmaceuticals, A.S. Rathore and G. Sofer, Eds.) Tayl…
Article
Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
Smith also notes that the adoption of single-use manufacturing technology accelerates process validation and analytical testing for Novavax’s vaccines and may allow for ultimate regulatory approval of…
Article
Biopharma Outsourcing Activities Update
Outsourcing activity remains strong and unlikely to abate, especially in more traditional areas.
Over the past 11 years, BioPlan’s annual report and survey of biopharmaceutical manufacturing ha…
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Outsourcing Trends in Biopharmaceutical Manufacturing
Beyond typically outsourced activities like fill-finish, validation services, and assays, companies are increasingly relying on their suppliers to address more challenging processes. From expertly pac…
Article
Predicting Progress in Protein Aggregation
Techniques to enable the design and formulation of stable, protein-based therapeutics.
In silico analysis and the evaluation of formulability, aided by new analytical tools such as hydrogen deut…
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Early Communication with Regulators is Essential for SMEs
“Quality documentation continues to be a problem area for many SMEs, particularly relating to manufacturing process validation, the setting of specifications, and stability data,” says the SME Office …
Article
2014 Manufacturing Trends and Outlook
Survey respondents represented research, development, formulation, and process development functions, as well as quality control/assurance, validation, and laboratory management titles at branded and …
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Comparing Protein A Resins for Monoclonal Antibody Purification
In addition, more cost-efficient cleaning procedures are necessary to extend the lifetime of chromatography resins and to reduce the cost for cleaning and validation. A team from Chugai Pharmaceutical…
Article
Trends in Downstream Bioprocessing
…ials
• Lack of single-use (disposable) options
• Cost of membranes
• Cleaning and validation costs
• Time for operations.
In addition, while many firms would like to avoid the hig…
Article
Biosimilars Development and Supply: How Complex Can the Process Be?
A typical biologic development route includes: preclinical discovery and validation of target; clinical development; drug approval, launch, and commercialization. During preclinical and early clinical…