Search results for " European Medicines Agency"

Article Setting Standards for Biotech Therapeutics in India
The authors take a look at the past and future impact of the Indian Pharmacopoeia Commission. By: Anurag S. Rathore, PhD, Renu Jain, M. Kalaivani, Gunjan Narula, G. N. Singh BioPharm Inter…

Article EMA Confirms Standards for COVID-19 Treatment Evaluations
The European Medicines Agency (EMA) sent an open letter to European Ombudsman Emily O’Reilly, dated Sept. 30, 2020, detailing the agency’s transparency plans for COVID-19 treatments and affirming its …

Article Innovative Therapies Require Modern Manufacturing Systems
FDA, the European Medicines Agency, and other established authorities, moreover, are collaborating more to avoid duplication in drug facility inspections and in the registration of innovative medicine…

Article Quality by Design—Bridging the Gap between Concept and Implementation
The drive to embed quality-by-design (QbD) principles into the pharmaceutical regulatory framework of the European Union has reached a key point 10 years after the European Medicines Agency (EMA) firs…

Article Reimagining Affordable Biosimilars
Advances in preclinical development play a crucial role in reducing cost for developing biosimilars.  By Anurag S. Rathore, Narendra Chirmule, and Himanshu Malani  Drug development is …

Article Aseptic Processing: Keeping it Safe
By Randi Hernandez, BioPharm International Humans represent the greatest risk for microbial contamination in an aseptic process. Aseptic processing has garnered some increased scrutiny…

Article The Evolving Role of Starting Materials in Cell and Gene Therapy
The Evolving Role of Starting Materials in Cell and Gene Therapy Accelerated approval pathways and growing demand for cell and gene therapies are putting pressure on providers of cellular starting m…

Article A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU Legal experts in biopharmaceutical patent law shed some light on trends and recent news. By Agnes Shanley …

Article Ensuring Viral Safety of Viral Vaccines and Vectors
While FDA, the European Medicines Agency, and the World Health Organization guidelines differ, testing must demonstrate the absence of bacterial, fungal, and viral contamination. A broad array of in-v…

Article Host-Cell Protein Measurement and Control
The European Medicines Agency (EMA) guideline CPMP/BWP/382/97 states, “In summary, for HCP, whatever the product and production system, residual HCP have to be tested for on a routine basis”…“As such,…

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