Search results for " china"
Article
Understanding Validation and Technical Transfer, Part I
The International Council for Harmonization (ICH), an organization composed of regulatory authorities from the US, Europe, Japan, Canada, Switzerland, Brazil, China, and the Republic of Korea, and rep…
Article
Biopharmaceutical Market in Asia: Q&A with Günter Jagschies, Strategic Customer Relations Leader, Cytiva
India and China have a strongly growing and well-funded biopharmaceutical industry focusing primarily on biosimilar proteins with several hundred projects in the pipeline. India is also in a leading p…
Article
Industry Adoption of Single-Use Systems Remains Low
The facility in the plans is Cellular Biomedicine Group’s (CBMG) Shanghai, China, cell therapy manufacturing facility. CBMG is a clinical-stage biopharmaceutical company focused on immunotherapies for…
Article
From Darwin to Recombinant Fc Multimers
Perkins expected more mergers and acquisitions to be happening in the future, with China involved when “East meets West.”
The first session of the conference was Manufacturing Perspectives, chair…
Article
Biopharma in 2016: Higher Quality Drugs, Less Expensive Manufacturing
The year ahead is expected to be marked by increased biosimilar development, lower drug prices, and better quality drugs.
The global biopharmaceuticals market was valued at $162 billion in 2014 a…
Article
A Second Modular Biopharma Facility Opens: KUBio in Hangzhou
To bring advanced biosimilar products to the Chinese market quickly, Pfizer’s Global Biotechnology Center will make use of Cytiva’s KUBio advanced modular manufacturing solution. KUBio modules …
Article
A Q&A on Bioprocessing Trends and Technologies at INTERPHEX 2016
One sign of progress was the opening of a JHL Biotech flexible manufacturing facility in Wuhan, China on May 10, 2016, for the manufacture of biosimilars and monoclonal antibodies (mAbs). The facility…
Article
Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Also, if producing at commercial scale, which regulatory standard is needed? Is the product approved by FDA, the European Medicines Agency (EMA), the China FDA, Brazil’s National Health Surveillance A…
Article
Platform Approach Speeds Process Development
…r direct process transfer from Germany (dotted line, average and standard deviation for two runs) to China (solid line, average and standard deviation for nine runs).
The implementation of disp…
Article
Framing Biopharma Success in 2016
Corporate restructurings, regulatory initiatives, and biosimilars will shape biopharma development in 2016.
By Rita C. Peters
The US biopharmaceutical industry turned a new page in 2015 when…