Search results for " production"
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
coli expression often yields high levels of protein production, often in the form of inclusion bodies, which require extra steps involving their isolation and the subsequent extraction and refolding t…
Article
Best Practices for Selecting a Top-Quality Cell Line
“A high-quality cell line should be well-rounded among the critical chemistry, manufacture, and control (CMC) production cell line attributes,” agrees Jill Cai, vice-president of cell and protein scie…
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Genetic Vaccine Platforms Demonstrate Their Potential
…ear the viral vector before it has an opportunity to insert the nucleic acid into a cell for antigen production,” he observes.
There are a multitude of approaches for non-live vi…
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Managing Biomanufacturing Capacity Expectations
According to a new survey by BioPlan Associates, more than half of respondents (60%) expect facility constraints to create biopharmaceutical production capacity constraints by 2021 (1). BioPlan found …
Article
Ensuring the Quality of Biologicals
First, there is a need for flexibility within biological monographs because of the requirement to cover heterogeneous products manufactured by different production methods. Nevertheless, there is a ne…
Article
Labeling of Biosimilars
EMA is under pressure to exert even tighter standards on biosimilars being marketed in Europe.
Feb 01, 2015
By Sean Milmo
BioPharm International
The European Medicines Agency (EMA) has r…
Article
Pharma Investments Reflect Key Industry Trends
18-22
Numerous trends in the pharmaceutical industry, and particularly in the biopharmaceutical sector, are leading to the need for smaller-capacity production facilities, which in turn is affect…
Article
Design Considerations for a Commercial Cell and Gene Therapy Facility
Different from mAbs
Considering the differences between monoclonal antibody (mAb) production and cell/gene therapy production is also important when establishing a cell/gene therapy facility. Al…
Article
Understanding Validation and Technical Transfer, Part I
FDA’s 2008 draft process validation guidance document defined process validation as “the collection and evaluation of data, from the process design stage throughout production, which establishes scien…
Article
Quality by Design and Extractable and Leachable Testing
One can also set baseline CQA that require packaging and production components meet basic entry-level quality attributes. Examples include the gravimetric leachable criteria for nonvolatile residues, …