Search results for " bioprocesses" in Articles / App Notes
Article
Applying GMPs to the BioPharma Supply Chain
Defining best biopharmaceutical practices is necessary to ensure the safety of the supply chain.
Manufacturing biopharmaceuticals carries great responsibility. The drugs produced must be availab…
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
An approach for establishing the CQAs of a mAb product by evaluating impact and uncertainty during risk assessment.
A critical quality attribute (CQA) has been defined as “a physical, chemical, …
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Concentrating Feed—an Applicable Approach to Improve Antibody Production
In this study, the authors evaluated different approaches to prepare highly concentrated feed media for fed-batch Chinese hamster ovary cell culture. By raising the pH or by adding surfactants, the fe…
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Global Expansion Shapes Drug Oversight
Regulators and industry organizations explain policies and standards to manufacturers and authorities in all regions.
Few FDA officials discuss pharmaceutical regulation these days without …
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Biopharma Takes a Nervous Glance Over Its Shoulder
Changes are needed to maintain US biopharma innovation leadership.
The US biopharmaceutical industry’s status as the global leader in innovative biopharmaceutical R&D is not guaranteed. Both…
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Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
New approaches to vaccine production are targeting rapid supply for pandemic situations and broadly effective therapeutic treatments.
Following the 2009 outbreak of the H1N1 pandem…
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Q&A with Industry Leaders: Rita Peters
This week, Process Development Forum's new Q&A feature interviews Rita Peters, Editor of BioPharm International Magazine, about second quarter trends in drug development.
Q: What trends have yo…
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Brazil Emerges as Global Biopharm Collaborator
Brazil is the first Latin American country to emerge as a global biopharmaceutical collaborator.
The pharmaceutical market in Brazil has been growing steadily and strongly in the past five ye…
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Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
As the European Union takes a closer look at its biosimilars guidelines, some key issues are proving difficult to resolve.
The European Union is strengthening its pioneering role in the regulati…
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Comparing Protein A Resins for Monoclonal Antibody Purification
A prototype Protein A resin is evaluated for purification performance, reusability, and cost performance.
With greater economic pressure on monoclonal antibody (mAb) production for therapeutic …