Search results for " healthcare" in Articles / App Notes
Article
Innovation vs. Capacity: How CMOs Compete
In Europe, in particular, government efforts to hold the line on healthcare costs have triggered a move away from branded generics to commodity generics that are procured by government tenders. Tender…
Article
Biopharma Advances Demand Specialized Expertise
As the healthcare industry seeks ways to improve patient care and reduce costs, the delivery to the patient needs to adopt new technologies and this is why we have seen a rise of prefilled syringes an…
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Use of Multivariate Data Analysis in Bioprocessing
Singh
BioPharm International
The ever increasing demand of biotherapeutics, together with the pressure to contain healthcare costs have motivated biotech manufacturers to focus on process opti…
Article
Ensuring the Quality of Biologicals
…n Europe: EMA, national authorities, and the European Directorate for the Quality of Medicines & HealthCare.
The Ph. Eur. intends to undertake further refinement of the format and content of mono…
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Modular Manufacturing Platforms for Biologics
Jornitz notes that there has been recent interest in the use of pods for analytical, microbial, polymerase chain reaction, and assay development, as well as interest in the use of pods for broader hea…
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USP Publishes Monoclonal Antibody Guidelines
… drugs in the United States, it is unquestionable that the role of biologics has rapidly expanded in healthcare, raising questions and presenting crucial issues associated with their quality and effi…
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Tackling Analytical Method Development for ADCs
…equired for product release, according to Allan Davidson, analytical development manager for Piramal Healthcare. “While processes can be developed to provide a consistent and accurate drug load, most…
Article
FDA Approves First Biosimilar
Still no comprehensive naming policy
The naming of a biosimilar has been a hot topic and a point of contention for many manufacturers and healthcare providers alike. For now, FDA is using a “place…
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Improving PAT for Biologics
Siemens is also exploring synergies with the analytical techniques applied for the healthcare sector, such as blood gas analyzers, to biologics production. “Sharing technologies looks quite promising …
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High-Throughput Process Development in an Historical Environment
A workshop held by Ashley Hesslein from Bayer HealthCare kicked off the meeting. The topic was “Lessons Learned in Building HTPD Capabilities” and comprised of a panel discussion and short presentatio…