Search results for " production"
Article
Quality by design for biotechnology products—part 1
A PhRMA Working Group's advice on applying QbD to biotech.
By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta,…
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Identifying CQAs for a biotech therapeutic is the first and arguably the most difficult step in implementation of quality by design (QbD) for development and production of biopharmaceuticals (3, 4). …
Article
Preclinical Evaluation of Product Related Impurities and Variants
…in an ordered manner, biotherapeutics present a different level of intricacies with respect to their production, and it is impossible to produce an exact replica of the drug in different batches orig…
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Overview of a scale-up of a cell-based influenza virus production process using ReadyToProcess equipment
The white paper includes a brief discussion around modern vaccine processes, followed by a case study showing the scale-up of upstream and downstream processes for the production of a cell based live …
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Antibody Production in Microbial Hosts
However, clinical success of mAbs has tremendously increased their demand, and this in turn has fueled interest in other cost-effective alternative production systems such as microbial hosts. Further,…
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Impurity Testing of Biologic Drug Products
… significant changes in efficacy, but understanding of the phenomena has led to improved, metal-free production processes.”
In general, impurities come from two major sources, observes B…
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Concentrating Feed—an Applicable Approach to Improve Antibody Production
Recombinant protein production in the biopharmaceutical industry mostly relies on fed-batch mammalian cell culture (1, 2). Often in fed-batch processes, the feed volume can be more than 1000 L for a 5…
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Gene Therapies Push Viral Vector Production
“This makes it a popular starting point for gene therapy, although many serotypes continue to struggle with manufacturing challenges, such as low production yields and therefore high cost of goods,” T…
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Commercial Production of Gene Therapies Using Suspension or Adherent Cell Lines
At the same time, the production platform selected to manufacture clinical material must be scalable in order to enable the target capacity to be reached and promote cost-effectiveness. Adherent cell …
Article
Ensuring Sterility in Small-Scale Production
What considerations are important for the small-scale production lots?
A. This situation always raises some interesting discussions. The statistical assurances for sterility for normal commercia…