Leaders in Pharmaceutical Business Intelligence (LPBI) Group

10:30 am – 11:30 am, 3/26/2015 – LIVE Better Business Track: It’s Not Your Grandfather’s Manufacturing @ MassBio Annual Meeting 2015, Cambridge, MA, Sonesta Hotel, 3/26 – 3/27, 2015

Reporter: Aviva Lev-Ari, PhD, RN

Dr. Aviva Lev-Ari will be in attendance on March 26, 2015, 8:00AM to March 27, 2015, 2:00PM

Leaders in Pharmaceutical Business Intelligence are Covering the Event in REALTIME using Social Media

http://pharmaceuticalintelligence.com

Panelists:

1. David Smith, Head, Cell Therapy Manufacturing, Lonza

• CMO, biotherapeutics
• scale up one billion today 100 billion possible
• Portsmouth, NH will integrate the MD and Singapore
• Cell Characterization — emerging area for research
• Cell therapy development is full of surprises, change in serum changes in cells unknown
• Cell Culture – GE system for 14 days culture development, At Novartis, manufacturing is small cost Logistics and Testing is expensive
• Specs of purity requires development
• push analytics upstream

1. Bayan Takizawa, Co-Founder & Chief Business Officer, Continuous Pharma

• manufacturing from 200 days now in two days for Novartis blood pressure drug
• batch manufacturing, reactor: reaction, separation, store – fragmented progress, upstream and down stream
• Novartis-MIT Center: Integration of process manufacturing, improve quality
• billion invested in continuous manufacturing of Biologics
• upfront work of characterization: pressure, temp, maintain process in steady state,
• FDA interested to continuous manufacturing vs old paradigm of testing at various milestones
• 50% cost reduction obtained, closed system no human interaction, no contamination
• Drivers: New Process phase, lean organization,
• drug discovery – reduce time to market if Batch need to scale up in continuous issue not important
• continuous is in infancy, FDA innovator partner
• inertia in the industry is still strong
• Small molecule companies reluctant to FULL integration concepts

1. Gary Welch, Plant Manager, AbbVie BioResearch Center

• 5 manufacturing suits – cell culture
• recombinant proteins
• bio specific
• conjugating large molecules to small molecule
• small flexible manufacturing
• drug product Elisa, done internally, virus testing is sent out,
• clinical development, comparability lot to tot comparability
• FDA requires continuous improvement Phase II to Phase III — continuous manufacturing need be planed for Phase III while no one know if Phase II will be successful
• continuous simplifies, disposable, simplifies
• antibody production will adopt continuous manufacturing — if gains will be clear to be realized
• batch will not disappear
• Contract employee for peaks, maintenance internal, testing is outsourced

Moderator:

• Geoff Hodge, Bioprocess Technology Leader, GE Healthcare Life Sciences

• Biotechnology – Genetic engineering, DNA technology, proteins, drugs moved to large scale industrial production
• Monoclonal Antibodies – required tanks for bioreactors, stainless steel, improve the process, better growth media, titers and solvent
• single use manufacturer
• Biosimilars competition from similar MOA
• Genzyme is Like a Pharma in all domain but like a Biotech in terms of innovator for manufacturing processing
• Biotech MOST regulated industry by FDA — yet a big innovator

GE Life Sciences in Marlboro, MA was created by an acquisition of a small Biotech manufacturing.

GE Life Science provided process and facility management and product management plans to be a big player in Life Sciences