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Developing Bioprocesses for Clinical Manufacturing Success

November 16 @ 8:30 AM - 12:00 PM

Location: National Research Council of Canada, 4250 Wesbrook Mall, Vancouver, BC, V6T 1W5

Agenda:

8:30 am – 9 am: Registration and Refreshments

9 am – 9:30 am: Welcome and Opening Remarks 

9:30 am – 11:30 am: Presentation and Round Table

11:30 am – 12 pm: Lunch and Networking

Establishing a CMC strategy and development of a manufacturing process for a biologic can be a complex undertaking, with many aspects to consider and potential pitfalls along the journey. This round table event will involve a presentation followed by discussions to review the key steps involved in the development of manufacturing processes for early phase biologics, where the desire for speed to clinic needs to be weighed against critical decisions in order to ensure the manufacturing process will support near term requirements and serve as a platform for longer term goals.

FUJIFILM Diosynth Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Billingham and Redcar, UK, RTP, North Carolina and College Station, Texas.  FUJIFILM Diosynth has over twenty-five years of experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems. The company offers a comprehensive list of services from cell line development using its proprietary pAVEway™ microbial and Apollo™ cell line systems to process development, analytical development, clinical and FDA-approved commercial manufacturing. FUJIFILM Diosynth Biotechnologies is a partnership between FUJIFILM Corporation and Mitsubishi Corporation. 

For more information, go to: www.fujifilmdiosynth.com

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Presenter: Nigel Shipston Ph.D  ARCS, Director of Program Design, Fujifilm Diosynth Biotechnologies Inc.

Bio:

Nigel Shipston is a Director of Program Design at Fujifilm Diosynth Biotechnologies. He is responsible for evaluating customer needs and developing technical scopes of work in proposals for customer programs. He has 27 years of industrial experience and has been at Fujifilm for the past 11 years as a Senior Technical Project Leader and Director of Program Design. Prior to joining Fujifilm, he was Head of Process Development at Angel Biotechnology and held Operations Management, Team Leader and Senior Scientist positions at Oxford GlycoSciences and Abbott Laboratories. He has been responsible for leading process development and manufacturing teams involved in the expression and production of numerous recombinant proteins and commercially useful enzyme products using E. coli, P. pastoris and CHO expression systems and from natural sources, as well as co-developing novel glycoprotein characterization and proteomic strategies. He received his BS from Imperial College, London and PhD from the University of Kent, UK.

Presentation topic: ‘Developing Bioprocesses for Clinical Manufacturing Success: A CMO Perspective’

One on one meetings:

If you are interested in applying for a one-on-one meeting slot, please provide a non-confidential, one-page summary on your company and the specific technology which you would like to discuss with FujiFilm Diosynth Biotechnologies. Please forward your application to Cynthia.Shippam@nrc-cnrc.gc.ca and type ‘CMO Application’ followed by your company name in the subject line. Space is limited so make sure to send in your application early.

Meetings will be 30-45 minutes long and held at the event space on the afternoon of November 16th following the meeting, or during the morning of November 17th.  Please include in your application a few different time slots that would work for you.

Time Slots:

Nov. 16 (1-1:45, 2-2:45, 3-3:45 or 4-4:45) and Nov. 17 (9-9:45, 10-10:45 or 11-11:45)

 

For more information please contact:

Ryan Butt, Manager Events & Outreach

Phone: 604 669-9909 ext. 104 & Email: rbutt@lifesciencesbc.ca

Details

Date:
November 16
Time:
8:30 AM - 12:00 PM
Event Category:

Organizer

LifeSciences BC

Venue

National Research Council (NRC)
4250 Wesbrook
Vancouver, BC V6T 1W5 Canada
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