Search results for " Korea"
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Monoclonal Antibodies Key to Unlocking the Biosimilars Market
South Korea has an approval process as well. In 2013, the Therapeutic Goods Administration in Australia issued guidance for biosimilar approvals.
“Many emerging market countries are actively dev…
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Establishment of New Modern Plasma Fractionation Facilities in Asia
In Korea, three companies are fractionating plasma: the Korean Green Cross, which operates two fractionation plants, the Korean Red Cross, and SK Plasma, which recently opened a new facility in Andong…
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The Future of Biopharma
In the second part of the article, Soon Jae Park, CEO of Alteogen, gives insights into challenges of establishing a biosimilars business in South Korea.
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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…
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Biopharmaceutical Market in Asia: Q&A with Günter Jagschies, Strategic Customer Relations Leader, Cytiva
This week, the Process Development Forum talks with Günter Jagschies, Strategic Customer Relations Leader, Cytiva, about the biopharmaceutical market in Asia.
The Asian market is most often s…
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Biosimilars: Making the Switch Comes with Challenges
Remsima, then marketed by Hospira in partnership with its developer Celltrion of Korea, won a national tender to supply it to all Danish hospital pharmacies that were able to switch patients to the pr…
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Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
For example, Chinese fire regulations demand a greater level of fire resistance than is typical globally, and in countries such as Korea and Japan earthquake-proofing measures may have to be implement…
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Biomanufacturing Outsourcing Globalization Continues
Top outsourcing destinations
Offshoring for biologics has been generally equated with emerging hubs in Asia, especially Singapore, China, India, or Korea. This trend is changing, as domestic CMOs …
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The Bullish Outlook for Biosimilars
Other markets, including emerging markets, such as Latin America and South Korea, have relied on both the European Medicines Agency (EMA) and the World Health Organization (WHO) for guideline developm…
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A Q&A With Parrish Galliher About Adopting Single-Use Systems
This week, Process Development Forum speaks with Parrish Galliher, Chief Technology Officer Upstream at Cytiva, about trends within the bioprocess area.
What’s one of the biggest t…