Search results for " healthcare"
Poster
Fast Trak Services: a collaborative project to accelerate downstream biosimilar process development
Biosimilars represent an innovative solution that can benefit both patients and healthcare systems by reducing the burden of rising treatment costs. To improve the availability, price and access of…
Article
Drug Quality Key to Innovation and Access
By Jill Wechsler
Amidst multiple challenges to the structure and governance of the US healthcare system, bio/pharmaceutical manufacturers will face a host of issues in bringing safe and effective …
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…
Article
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…
Article
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…
Article
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…
Article
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…