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BioPharm March eBook - Outsourcing Resources

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www.biopharminternational.com March 2018 BioPharm International eBook 35 Outsourcing Resources Market Investment I nter nat iona l Orga n i z at ion for Standardization-compliant clean- room for si ngle -use d isposable container manufac t ur ing at its Fermoy, Ireland, facility (9). The new Fermoy cleanroom will strengthen ABEC's custom single run single-use product offerings and will be operational in April 2018, according to the company. The first cleanroom, located in Bet hlehem, PA, has been f ully operational since 2015. Recent market investments include single-use process solutions and oncol- ogy pipeline growth. S a r t o r i u s S t e d i m B i o t e c h announced on Jan. 4, 2018 that it will be the equipment supplier in the United States for Abzena, a life-sciences group that provides services and technologies for the development and manufacture of biopharmaceuticals (10). Abzena has selected Sartorius Stedim to equip its integrated con- tract development and manufac- turing facilities in Bristol, PA, and San Diego, CA. The Bristol facility does development and GMP man- ufacture of antibody drug conju- gates, and the San Diego facility does development and GMP manu- facture of monoclonal antibodies and other recombinant proteins. Under the agreement, Sartorius Stedim will provide both facilities with end-to-end process solutions in single-use format. The company will equip Abzena's San Diego pro- cess development lab with industry technologies, including Ambr250, which enables fast scale-up to 500L initially and later to the 2000 -L sca le si ngle -use bioreac tor for Abzena's center of excellence in clinical manufacturing. "In addition to having selected Sartorius' industry leading single- use technologies for antibody and ADC production, the Abzena facili- ties will feature Umetrics process analytics software throughout the process, ensuring that all the data captured throughout our clients' molec ule development is trans- formed into process knowledge. [This ensures] that we can rapidly develop a robust and reliable pro- cess that can be easily scaled up to ensure a smooth technology trans- fer," said John Burt, Abzena's CEO, in a company press release. O n J a n . 4 , 2 018 , c o n t r a c t m a n u f a c t u r e r W u x i G r i f f i n announced the completion of a new 27,450 -ft 2 aseptic fill/finish facility in Wuxi, China (11). The facilit y is equipped w it h t hree filling suits and uses restricted access barrier systems and isola- tor production technology. According to the company, the facilit y is compliant with GMP standards and offers manufactur- ing services for monoclonal anti- bod ies, vacc i nes, recombi na nt proteins, biosimilars, and small- m o l e c u l e d r u g s . S m a l l - a n d medium-sized batch clinical trial manufacturing and commercial manufacturing are also available. " T h e r e a r e f e w d o m e s t i c C h i ne s e c ont r ac t m a nu f ac t u r- ers t hat a re inter nat iona l play- ers. There is a gap between the Chinese manufacturers capabili- ties and the reg ulator y require- m e nt s f r o m t h e We s t . W u x i G r i f f i n i s f i l l i n g t h i s g ap b y of fe r i ng we ste r n GM P compl i- ance f rom China," said Torg ny Lundgren, CEO of Wuxi Griffin, in a company press release. REFERENCES 1. Charles River Laboratories International, "Charles River Laboratories to Acquire MPI Research," Press Release, Feb. 13, 2018. 2. Charles River Laboratories International, "Charles River Laboratories Acquires KWS BioTest," Press Release, Jan. 11, 2018. 3. AGC Biologics, "AGC Bioscience, Biomeva, and CMC Biologics to Provide Services Under the Brand AGC Biologics," Press Release, Jan. 8, 2018. 4. AGC, "AGC to Expand Production Capacity at Its Subsidiary CMC Biologics Copenhagen, Denmark Facility," Press Release, Sep. 25, 2017. 5. AGC, "AGC to Expand Production Capacity at Its Subsidiary CMC Biologics Copenhagen, Denmark Facility," Press Release, Sep. 25, 2017. 6. Meissner Filtration Products, "Meissner Acquires an Aseptic Filling Company," Press Release, Jan. 12, 2018. 7. Samsung BioLogics, "Samsung BioLogics Announces the First Contract for its Plant 3 Facility," Press Release, Feb. 12, 2018. 8. Industrial Development Agency Ireland, "AbbVie Expands Oncology Capability at the Company's Site in Ballytivnan, Sligo," Press Release, Jan. 16, 2018. 9. ABEC, "ABEC Expands Manufacturing Capability of Single-Use Disposable Containers for Biopharmaceutical Manufacturing," Press Release, Feb. 13, 2018. 10. Sartorius Stedim Biotech, "Abzena Selects Sartorius Stedim Biotech to Equip its US-Based Development and Manufacturing Sites in San Diego and Bristol," Press Release, Jan. 4, 2018. 11. Wuxi Griffin, "Wuxi Griffin Manufacturing Facility in Wuxi, China," Press Release, Jan. 4, 2018. BP Ad Index Company Page WUXI APP TEC 2 EUROFINS LANCASTER LABORATORIES 5

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