Search results for " drug" in Articles / App Notes
Article
Speed and Flexibility Are Dual Goals for Biopharma Operations
What trends did the BioPharm International editorial team observe about manufacturing facilities and operations?
As demand for biologics drug manufacturing increases capacity, contract manufacture…
Article
Efforts Accelerate to Streamline Postapproval Change Process
By Jill Wechsler
Frequent revisions and updates in manufacturing processes and operations are routine after a drug comes to market to improve products and systems and ensure reliable supply of hig…
Article
Microbiological Testing: Time is of the Essence
Challener
Effective microbiological testing during biopharmaceutical drug development and manufacturing is crucial for ensuring sterility, determining antimicrobial effectiveness, detecting microbi…
Article
Ligand-Binding Assays and the Determination of Biosimilarity
…rmacokinetics (PK), and immunogenicity of the biosimilar are also comparable to those of the branded drug. Consequently, functional assays, such as ligand-binding assays (LBAs) and mechanism of actio…
Article
2014 Manufacturing Trends and Outlook
More than half of the respondents work for organizations that produce both small- and large-molecule drugs; 25% added a biopharmaceutical-manufacturing program in the past year.
The responses i…
Article
Maximum Output Starts with Optimized Upstream Processing
…development and large-scale manufacture, and forge partnerships to secure secondary sources in their drug supply chains, according to Kim. “Having a stable secondary source plays an essential role wh…
Article
Eliminating Residual Impurities Starts with a Strategic Plan
…minimize the impurities that may be present at the end of the production process (drug substance and drug product). While building a knowledge base on residual impurities requires investment, that in…
Article
Implications of Cell Culture Conditions on Protein Glycosylation
Protein therapeutics and cell-culture effects on protein quality
Biopharmaceutical drugs are proteins with polymeric structures, built up in a series of structural levels starting from the amino-ac…
Article
Best Practices in Qualification of Single-Use Systems
Figure 1 depicts a typical monoclonal antibody (mAb) drug manufacturing process. Single-use bioreactors are widely used in cell line expansion, and the use at production scale is increasing, notably i…
Article
Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
…Zeneca: We often use a modified version of the FMEA tool, similar to what is published in Parenteral Drug Association (PDA) Technical Report (TR) 44 and PDA TR 54 (for biopharmaceuticals) (3, 4). An …