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Article Biomanufacturing Outsourcing Globalization Continues
opened its Life Sciences Centre of Excellence in Shanghai, which offers biopharma process solutions (CMO work), technical, and validation support as well as training (5). Beyond China and India, L…

Article Modular Manufacturing Platforms for Biologics
Some of the oft-mentioned challenges associated with modular models deal with technical construction and the workforce planning and training required to get a facility fully operational. On-site const…

Article Continuous Manufacturing: A Changing Processing Paradigm
Apr 01, 2015 By Randi Hernandez BioPharm International Volume 28, Issue 4 Although continuous manufacturing is well established for bulk chemicals, complex automation and validation …

Article Technologies and Practices Must Evolve to Meet Demand
Barriers to implementation remain; almost half of the respondents cited a lack of knowledge or training; 39% noted a lack of clarity on regulatory guidance; more than 25% noted a lack of management bu…

Article Optimizing Resin Performance with Disposable Chromatography Solutions
Although the initial uptake of single-use chromatography solutions has been relatively slow, an increased need for higher-capacity resins and the demand for smaller batches has made disposable chrom…

Article New Era for Generic Drugs
Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes. Nov 1, 2014 By: Jill Wechsler BioPharm International Volume 11, Issue …

Article Setting Standards for Biotech Therapeutics in India
The government, through agencies such as the Department of Biotechnology, actively funds events that allow for training and sharing of best practices and lessons learned. Such activities are essential…

Article Pharma Investments Reflect Key Industry Trends
Roche is also spending $105 million on a new packaging and logistics training center in Switzerland. Sanofi: Sanofi is investing in emerging markets. The company is not only increasing insulin pro…

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 Biopharma Outsourcing Activities Update
Outsourcing activity remains strong and unlikely to abate, especially in more traditional areas.   Over the past 11 years, BioPlan’s annual report and survey of biopharmaceutical manufacturing ha…

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