Why You Should Attend IN3 Medical Device 360 Summit This Fall

IN3 brings together buy side strategics, VCs, and medtech innovators to build the necessary connections to expand portfolios, secure funding, and drive medical device progress. This event not only provides you with insights from experienced strategics and investors, it also provides you with a state-of-the art partnering tool to maximizes your networking capabilities.

Top Reasons to Attend IN3:

Know What Investors Look For. Crafting the right narrative and showcasing the best value metrics are essential to selling your technology. Discover exactly what criteria Strategics and VCs use to evaluate potential acquisitions. Download the agenda: http://bit.ly/1OCI0nd

Pitch to Put Your Technology on the Map. Competition is fierce in the medtech sector. Do what it takes to rise above your rivals -- pitch your technology to a global audience of top-tier investors. Secure Your Spot before Your Rivals Take it. Apply Now: http://bit.ly/1izpUbE

Find Your Next Partner. Introducing partneringONE®, the perfect platform for meeting exactly the right person at exactly the right time. Leverage partneringONE® to pre-arrange one-on-one meetings with the high-level decision makers you’ve been searching for. Move beyond chance encounters and conduct more quality meetings in two days than most companies do throughout the entire year.  Explore how it works: http://bit.ly/1KcxBPp

Also, here’s the event’s keynote lineup:

• Chris King, VP, Business Development and Strategic Partnering, Medtronic
• Bill Roskopf, VP, Business Development and Strategic Planning, Stryker
• Sherrie Perkins, VP, Business Development, Sorin Group
• Evelyn Douglas, VP, Corporate Strategy & Development, BD
• Jeff Karan, Managing Partner, Mavericks Capital
• Gil Kliman, Managing Director, InterWest Partners
• Ted Driscoll, Partner, Digital Healthcare Lead, Claremont Creek Ventures
• John Ryan, Partner, ONSET Ventures
• David Allison, Investment Professional, Versant Ventures
• Andrew Baldwin, Principal, Western Technology Investment
• Arthur Pappas, Managing Partner, Pappas Ventures
• Ittai Harel, General Partner, Pitango Venture Capital
• Gregory Grunberg, Managing Director, Longitude Capital
• Zack Scott, Managing Partner, Leerink Revelation Partners
• Bill Starling, Managing Director, Synergy Life Science Partners
• Jeffery T. Barnes, Managing Director, BioVentures Investors
• Greg Grunberg, Managing Director, Longitude Capital

As a valued reader of our blog, you get an exclusive $100 off the current rate when you use code IN315BL to register: http://bit.ly/1OCI0nd

We hope to see you in San Francisco this Fall!

Cheers,

The IN3 Team

@FutureofBioPharma

#IN3SF

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QbD for Cell Culture: Four steps for creating a 'design-space'

Quality by Design (QbD) is an approach to developing control strategies for biopharmaceutical manufacturing strategies that seeks to instil quality into the production process rather than relying on the testing of product quality once produced. The QbD paradigm for biomanufacturing has its origins in the FDA’s ‘cGMP initiative for the 21^st century’ from 2004.

Three key components of QbD for Biologics

Three key components of the QbD approach have been previously defined as:

1.    Process knowledge with an understanding of inputs and their impact on process performance.

2.    Understanding the relationship between the process and the product’s critical quality attributes (CQAs)

3.    Understanding the connection between CQAs and a products clinical properties (Rathore & Winkle, 2009, Nat Biotechnology 27(1) 26-34)

Tom Hayes from Genzyme will be presenting on the ‘Application of Quality by Design principles to the development, characterization and scale-up of a late stage perfusion cell culture process” at BPI Boston, 2015 as part of the Process Characterization, QbD and Technology Transfer session.

It will be interesting to see the extent to which it draws on the work of Abhinav Shukla and co-workers from Bristol-Myers Squibb published in 2010 entitled “Defining process design space for monoclonal antibody cell culture” (Abu-Absi et al., Biotechnol Bioeng, 106: 894-905)

A four step approach to defining a design-space for cell culture

Shukla and the team developed process understanding in which the effect of varying input variable on CQAs was understood for a non-continuous cell culture step with the following approach:

1.    Use of failure modes effects analysis (FMEA) to identify and allocate a risk priority number to process parameters and that could influence cell culture performance.

2.    Qualification of a 7L scale-down production bioreactor model.

3.    Two stage design of experiments methodology (2-level Resolution IV and face-centered central composite designs) with the scale-down model to map the design space.

4.    Performance of linking studies to show the effect of upstream conditions on process- and product-related impurity clearance by downstream purification steps.

The link between cell culture process parameters and CQAs

The group found that production bioreactor pH, temperature and initial viable cell density impacted product glycosylation and basic banding on isoelectric-focussing gels. Bioreactor temperature also affected product deamination. Host cell protein levels in Protein A eluates was shown to be impacted by the cell viability at harvest.

Have your say

To what extent to you think the industries approach to QbD for cell culture steps has developed since the Shukla paper from 2010? How applicable is a study such as this, based on non-continuous culture, be too continuous cell culture?

 

Dr Nick Hutchinson

Join me at #BPIconf

Dr Nick Hutchinson has a Masters and Doctorate in Biochemical Engineering from University College London, UK where he focused on laboratory tools for rapid bioprocess development and characterization. He then worked at Lonza Biologics in an R&D function investigating novel methods for large-scale antibody purification before moving to an operational role scaling-up and transferring manufacturing processes between Lonza sites in the UK, Spain and USA. Nick now works in Market Development at Parker domnick hunter where his focus is in bringing Parker's strengths in Motion & Control to Bioprocessing. This will enable customers to improve the quality and deliverability of existing and future biopharmaceuticals.

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