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PDA New England Chapter Dinner Event and Facility Tour - Future Trends in Manufacturing

Mar 14 - Mar 14, 2018 |
Mar 14, 2018 |
MilliporeSigma | Burlington, MA
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Topic: "Future Trends in Manufacturing"
with Venkatesh Natarajan and Aaron Noyes

Tours of: MilliporeSigma's new, state of the art M Lab(TM) Collaboration Center in Burlington, MA

General Meeting format

Tours start at 4:15 pm
Sponsors can begin setting up at 4:45 pm
Registration/cocktails/social hour with sponsors: 5:30 - 6:30 pm
Dinner starts approximately 6:30 pm
Introductions and presentations begin at approx. 7:00 pm

Tour Information

Facility Tours 4:15-5:15pm, Wednesday, March 14th

Location: MilliporeSigma
400 Summit Drive
Burlington, MA 01803

Description: NEPDA is offering an opportunity to visit MilliporeSigma's new, state of the art M LabTM Collaboration Center in Burlington, MA. Inside the M LabTM you can see pilot and process development labs containing biomanufacturing equipment used in multiple unit operations including upstream single-use bioreactors and clarification tools as well as downstream chromatographic purification and tangential flow concentration systems. The M LabTM Collaboration Center is a place where visitors have the freedom to explore applications and run experiments in an innovative, non-GMP environment.

Tour space is limited!!
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Speakers

Can Non-Mammalian Hosts be the Future Expression System of Choice for Antibodies?
Venkatesh Natarajan from Biogen

Venkatesh Natarajan has 18 years of experience in the biotechnology industry. He obtained his PhD under the guidance of Prof. Steve Cramer at Rensselaer Polytechnic Institute, Troy, NY. His dissertation looked at optimizing ion exchange processes for protein purification. He is currently a Principal Process Engineer at Biogen, Cambridge, MA. His responsibilities in this role include developing process and cost models for all modalities - small molecules, oligonucleotides, gene therapy and antibodies. Prior to Biogen, Venkatesh was an Applications Engineer at Millipore for 14 years, where he developed applications for the various chromatography and filtration products.

Advances in CHO process engineering with increases in protein productivity have enabled the industry to reduce the cost of antibody manufacturing. High dose treatments for neurodegenerative diseases, coupled with a large patient population lead to such scale of operation that the contribution of the raw materials to the overall cost of manufacturing begin to gain in importance. Biogen partnered with MIT to take a holistic view of antibody manufacturing to identify technologies for step changes in productivity and cost reduction. Rationale of why CHO may not be the ideal host for future antibody production, cost modelling and process concerns along with a review of a comparative analysis between the eight alternative hosts will be discussed.

Manufacturing Process Development Challenges for Exosomes, a New Therapeutic Platform for the Delivery of Biomolecules
Aaron Noyes from Codiak BioSciences

Aaron Noyes is a Senior Scientist in Downstream Processing at Codiak BioSciences where he leads a team focused on developing scalable production processes for exosomes and robust technology to load varied payloads into exosomes. Prior to Codiak, Aaron worked for 12 years at Pfizer, Andover, MA where he developed purification processes and focused on scale-up of mAbs, recombinant proteins, ADCs, vaccines, cell therapies, and viral vectors. Earlier Aaron developed chromatography products and filtration applications at Millipore. Aaron received an ME in Biotech Engineering from Tufts and a PhD in Biochem Engineering at University College London focused on developing modular, high throughput tools for polysaccharide vaccines production.

Exosomes have emerged as a therapeutic platform that could allow for the development of highly potent and directed therapeutics. Codiak BioSciences has created a scalable exosome production platform based on chemically-defined, suspension cell culture with purification using advanced downstream unit operations. The potential of exosome-based therapeutics and the bioprocessing technologies for their future commercialization will be discussed in the context of the capabilities and limitations of the existing biomanufacturing platforms. Codiak BioSciences' development strategy will be described and supported by case studies from process development including examples of challenges specific to working with large macromolecular complexes.

Meeting Hosts

Kathleen Souza
R&D Manager Virology & Microbiological Sciences
MilliporeSigma

Stephanie Ferrante
Associate Director Technology Management
MilliporeSigma

Don McCarthy
Senior Application Specialist
MilliporeSigma

Registration

PDA Members: $75
PDA Student Members: $10
PDA Retired Members: $10
Unemployed Members: $10
Non-Members: $95

Not yet a member of PDA?
Join today and attend this meeting for free! Email Trevor Swan once you have completed your membership purchase to be registered at no charge for this event.

Register online by 12:00 Noon, Friday, Mar. 9th

Late registrations will be accepted after noon on March 9th on a
space-available basis.

Late Registration is $115 for all.

For late registration contact Events@ne-pda.org. Late registration payment will be accepted at the door. You can now pay for late registration with your credit card.

NEPDA Upcoming events

May 16th, 2018 Dinner Meeting
September 12th, 2018 Dinner Meeting
September 26th, ISPE show at Gillette Stadium in Foxboro
November 14th, 2018 Dinner Meeting

 

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