Exclusive Interview with Larry Couture, VP, Center for Applied Technology Development, City of Hope

Dr. Larry Couture, Vice President of Center for Applied Technology Development, City of Hope - a Keynote Speaker at this years Cell Therapy Bioprocessing & Commercialization Event, sat down to discuss the biggest challenges facing regenerative medicine developers, how pharma companies benefit from learning the academic model for translation, regulatory hurdles, and this years meeting. Below you will find a brief teaser from the interview, to access the full interview, follow the links below...

Podcast | Transcript

What are the biggest challenges facing regenerative medicine developers?
Well, the field is really beginning to take off. There are now four or five or six clinical trials and probably at least as many academic trials – some of those are academic – that are about to enter the clinic or will be entering the clinic in the next couple of years. 

One of the problems and challenges that are starting to emerge about where this is going to go and what we are going to have to face and some of the issues we are dealing with right now that I think are going to become big are cost of goods, the ability to scale-up some of the manufacturing processes that we are using purity to sell product. Not necessarily trying to achieve 100% per se, but trying to optimize purity and identify how pure these products should be...[Click here to read more]


Want to hear more from Dr. Couture? Join him in Alexandria, VA for Cell Therapy Bioprocessing & Commercialization, September 30 - October 2, 2015 - where he will have a keynote address titled "Development of a Well Characterized Regenerative Medicine Cell Product". Register now with the code XB15188BLOG to save $100 off the current rate.

See you in Alexandria!

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Bioprocessing Cell Therapy Products Demands Greater Automation

Cell therapy bioprocessing is undergoing significant developments at the moment. Bioprocess engineers that have developed their skills on vaccine or recombinant protein production will recognise the types of challenges experienced by those attempting to manufacture cell therapies, namely, process development, innovation, operations and process transfer, process characterization and the setting of specifications.

Finding solutions to process and technology cell therapy bottlenecks is the topic of a presentation at the Cell Therapy Bioprocessing BPI Boston, Pre-Conference Symposium from invited speaker Nick Timmins. Nick has previously co-authored a review of cell therapy bioprocessing in BioProcess International 12(3) March 2014 entitled ‘Cell Therapy Bioprocessing Technologies and Indicators of Technological Convergence’.

Increased Sensitivity to the Bioprocess Environment

In the review the authors describe how cells in cell therapy bioprocesses are “biologically dynamic” and highly sensitive to the bioprocess environment in which they are produced. This will have a direct impact on a cell therapies critical quality attributes. In contrast, industrial cell lines that are typically used to produce recombinant proteins are more stable during processing and the final protein product are less directly dependent on the culture and processing environment.

Bioprocess automation mitigates risks in patient-specific therapy production

Bioprocessing technologies used for cell therapy manufacture typically require a higher level of automation which allows for a greater level of control of the bioproduction environment which can impact product CQAs, however it also enables operators to run multiple upstream and downstream protocols simultaneously to produce, what could be, patient-specific therapies. The patient-specific nature of some cell therapies adds in an additional layer of complexity to the processing requirements, not typically found in biomanufacturing, driven by the need to prevent the mishandling or cross contamination of patient tissues. Process automation can help mitigate against some of these risks through ensuring the rigorous control and identification of biological materials as they are produced. More manual process interventions increase the opportunities for errors, contaminations and even abuse.  

The BioProcess International Conference and Exposition will be held on October 26-29, 2015 in Boston and the Cell Therapy Pre-Conference Symposium is scheduled to take place on October 26^th.

Dr Nick Hutchinson

Join me at #BPIconf

Contact me at nick.hutchinson@parker.com

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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Major Challenges Facing Immunotherapy Developers

  

Dr. Marc Better, Vice President of Product Sciences, Kite Pharma - a Keynote Speaker at this years Cell Therapy Bioprocessing & Commercialization Event, sat down to discuss the current projects he is working on at Kite Pharma, the biggest challenges facing immunotherapy developers, regulatory hurdles, and this years meeting. Below you will find a brief teaser from the interview, to access the full interview, follow the links below...

Podcast | Transcript

What are the biggest challenges facing immunotherapy developers?

Well really, I think the biggest challenge for us is that we are charting new ground. There really isn’t a lot of precedent for bringing this type of product to the market. However, we do know - at least in the early trials we are seeing really exciting results both with our collaborators at the NCI and other institutions. We are building a lot of processes and systems around this to allow us to expand these programs and commercialize products like KTC 19.

Any field that is as innovative and exciting as this is very challenging, but we are very committed to being the best in the area that we can possibly be....[Click here to continue reading] 


Want to hear more from Dr. Better? Join him in Alexandria, VA for Cell Therapy Bioprocessing & Commercialization, September 30 - October 2, 2015 - where Dr. Better will have a keynote address titled "Overcoming Challenges for Engineered Autologous T-Cell Therapy". To see the complete agenda, click here. And register now with the code XB15188BLOG to save $100 off the current rate.

See you in Alexandria!

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The 3 Biggest Challenges Facing Regenerative Medicine Developers

 
Dr. Julie Allickson, Director of the Regenerative Medicine Clinical Center, Wake Forest Institute for Regenerative Medicine and Wake Forest School of Medicine - also a keynote speaker at this years Cell Therapy Bioprocessing & Commercialization event - sat down with us for a podcast interview. During the interview, Dr. Allickson discusses the future challenges for regenerative medicine developers, how pharma companies that are developing regenerative medicine therapies can benefit from the academic model for translation, the regulatory hurdles that regenerative medicine developers face, the key differences between the industry in North America, Europe and Asia, as well as her talk at this years meeting. Below you will find a teaser from the interview...Interested in hearing more? Access the complete interview now...

Podcast | Transcript

Where do you see the biggest challenges facing regenerative medicine developers over the next five years?

I think there are several different challenges, but when I really try to add those up I feel that there is a lot that we need to develop yet to get a robust manufacturing process. I think there is a lot that goes into making sure that the product is safe and meeting all the requirements for the regulators. But also, as we are looking at scaling up, scaling out the products, I think that there are a lot of efforts that we still need to put into that.

The other piece would be looking at automation and really pushing the automation to decrease what I’m going to say is the “human factor”, which can bring error and, actually, it would be much more timely. So, I think that the field really needs to push for the automation to be able to get more of a robust manufacturing process.

We actually just published a paper in February in stem cells translational medicine with Josh Hunsberger as the primary author, but really looking at the roadmap for tissue engineering and regenerative medicine in the manufacturing space. I believe that that’s definitely one of the challenges, but I think, also, we have challenges in clinical trial design.

There is a lot of failure – I would say – in clinical trials as we are learning, but I think it is getting better. As we nail down the appropriate patient populations, we’re not so broad and incorporate control groups and also really being thoughtful as we are looking at the end points in clinical trials. It is very critical as we’re selecting what matches up with the potency of the product. I think that’s definitely key.

Then, I would say third would be regulatory considerations. As we move forward, we know it’s really a new paradigm – regenerative medicine – in healthcare and I think that gives us the opportunity to be able to voice our concerns, educate the regulators so that they really understand what we need.

So, I think it is definitely communication, educating the regulators and I think that the more opportunity that we have to facilitate those discussions, the better place that we’ll be in because there is such an opportunity for healthcare if we can accelerate the commercialization of some of these products.


Want to hear more from Dr. Allickson? Join her in Alexandria, VA for Cell Therapy Bioprocessing & Commercialization, September 30 - October 2, 2015 - where Dr. Allickson will have a keynote address titled "Academic Model for Translation of Regenerative Medicine Including Tissue-Engineered Products in the 21st Century: What are the Pathways? What are the Barriers?"

Download the agenda | Register for the event 

We hope to see you in a few weeks!

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Interviews with Cell Therapy Bioprocessing & Commercialization Keynote Speakers Marc Better and Julie Allickson

Register by Friday, September 4 and save $300 | Use code: XB15188BLOG

Gain a sneak peek of this year's upcoming Cell Therapy Bioprocessing & Commercialization meeting by listening to exclusive interviews between IBC Life Sciences and keynote speakers Dr. Marc Better (Kite Pharma) and Dr. Julie Allickson (Wake Forest School of Medicine).

Access the interviews here.

Register today to attend this year's meeting, held on September 30 - October 2, 2015 at the Hilton Alexandria Mark Center in Alexandria, VA. By attending in person, you will gain direct access to 80+ speaker presentations, 15+ exhibitors and Attendee Connect, the conference app and partnering tool. Visit the event website for full program details.

Rates increase this Friday, 9/4 – Save $300 now with the code XB15188BLOG

We hope to see you in Alexandria later this month!

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Unique Challenges of Cell Therapy Bioprocessing

Joining us in this Cell Therapy Bioprocessing & Commercialization Podcast is Lee Buckler, Cell Therapy Group. Lee discusses the state of the industry and unique challenges that this event is helping tackle. Below is a brief excerpt from the podcast, follow the links below to access the complete podcast and transcript.

Listen to the podcast | Read the transcript

What are some of the unique challenges of cell therapy bioprocessing that this event is helping the industry to tackle?

Well, I think that one is just the cross flow of expertise that I mentioned before. So, one of the reasons why I think this Event has been so successful is because it is so closely associated with the bioprocessing journal, as well, in which we’ve really been trying to raise the level of publications related to cell therapy bioprocessing to try and encourage that cross flow of expertise and exchange of information between those in traditional biologics bioprocessing and those who are still cutting their teeth in cell therapy bioprocessing. So, the lack of that cross flow has been one of the challenges that we face. Bringing people in who have experience with larger-scale systems. Cell therapy is still being produced in relatively small scales. Even when we think it’s big scale, it’s still relatively small scale. So, bringing people with large-scale experience and thinking ahead about how these cell products are going to be manufactured on a large scale if we get great clinical efficacy is a tremendous asset.

Other than that the unique challenges differ significantly depending on whether you’re talking about autologous vs. allogeneic. One of the challenges with autologous is that it doesn’t really scale-up very well because a batch is a lot. So, there is a lot of cost of goods embedded in the human processing and in the testing. So, innovation with autologous cell therapies is around closing systems up. Potentially they don’t have to be inside playroom environments and/or in bringing lower cost batch testing solutions to cell therapy products.

When you’re looking at allogeneic, of course, depending on whether you’re looking at an adherent or non-adherent cell population, you’re really looking at how can you take the cell expansion process from key flasks or roller bottles or vats into tanks where we can do scale-up at a much larger scale and hopefully, potentially, reduce the media consumption because media consumption is the largest – as has been pointed out in past sessions of this conference – media consumption is the largest cost driver.

Some of the really important data that has been presented here and then also published in Bioprocessing International is some of these metrics around what is the exact cost of the processing technology that we are using today vs. what we are going to have to get to in the future.


Be sure to join us at Cell Therapy Bioprocessing & Commercialization in Alexandria, VA - September 30th to October 2nd, 2015. Register before 9/4 and save $300 with the code XB15188BLOG.

Register here | Download the agenda

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What are the supply chain challenges associated with the commercialization of cell therapy products?

Joining us in this Cell Therapy Bioprocessing & Commercialization Podcast is Jessica Carmen, Business Development Manager of Lonza Walkersville. Jessica discusses supply chain & logistical challenges associated with commercialization, the evolution of the cell therapy field and where it is headed in the next five years, advancements in technology and much more. Below is a brief excerpt from the podcast, follow the links below to access the complete podcast and transcript.

Listen to the podcast | Read the transcript 

Are there unique supply chain challenges associated with the commercialization of cell therapy products?

Yes, there are. There are many raw materials that are used in the manufacture of cell-based products that can pose a challenge when considering commercial needs, an example of which is the animal serum. Most cell types are culture-expanded in animal serums and there is a move in the field towards serum-free conditions. This is good from a supply chain and safety risk standpoint. However, most companies still employ animal serum in their processing and will need to consider the increasing costs and logistical challenges associated with the ever-increasing demand for this raw material. 


Be sure to join us at Cell Therapy Bioprocessing & Commercialization in Alexandria, VA - September 30th to October 2nd, 2015. Register before 9/4 and save $300 with the code XB15188BLOG.

Register here | Download the agenda

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Today's Challenges in Cell Therapy

 

Joining us in this Cell Therapy Bioprocessing & Commercialization Podcast is Marty Giedlin, VP of Development at Sangamo BioSciences, Inc. Marty discusses key industry challenges, the evolution of the cell therapy field and where it is headed in the next five years, advancements in technology and much more. Below is a brief excerpt from the podcast, follow the links below to access the complete podcast and transcript.

Listen to the podcast | Access the complete transcript

What are the challenges that you’re experiencing in your industry?

Well, I guess it really depends on what kind of cell therapy you’re talking about. We at Sangamo are processing both autologous T-cells and autologous stem cells. We have the most experience in our T-cell program where we knock out the CCR-5 receptor for HIV in HIV-positive patients. So, the challenges are trying to find that patient population that’s most amenable to this type of therapy, both in viral load, how many years they’ve been in retroviral therapy and that sort of thing. And also finding out which of the CD4 cells – which sub-population – is most important in controlling HIV. So, those are some of the challenges that are facing us there.

With our stem cell program, we have a partnership with CIRM (California Institute for Regenerative Medicine) in California with the City of Hope where we are looking at using CD34 stem cells either from peripheral blood or from bone marrow. What sub-population of those cells are really those that have the capacity for self-renewal over time? Those are the cells that we really want to target to do our gene modification technology.

Then, there are culture conditions to minimize replication, retain stemness and maximizing engraftment with respect to CD34s. And then we’re looking at ways of mobilizing peripheral blood CD34s and how does that affect stemness with respect to CD34s? And then also looking at different ways of bone marrow harvest. So, are there better ways of getting maximal yield to make sure we get enough cells to give back to the patient?

So, for us in the adoptive cell therapy, those are some of the challenges that we’re looking at over the next three to five years.

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How will cell therapy change in the next five years?

Joining us in this Cell Therapy Bioprocessing & Commercialization Podcast is Anthony Davies, President of Dark Horse Consulting. Anthony discusses key industry challenges he is seeing, the evolution of the field in the next five years, some exciting new initiatives he is working on, regulatory issues and much more. Below is a brief excerpt from the podcast, be sure to click on the links below to access the complete podcast.

Listen to the Podcast | Access the complete transcript

How do you see the field of cell therapy changing in the next five years? 

I believe strongly that the next five years will bring the first significant drug approval. This will be a transformative moment for the field. A lot of players who are sitting on the wings will move in and there will be a big acceleration. Who will benefit from that the most are the organizations and the entities which have spent the difficult, recent years preparing and positioning themselves the best. 

I think we would do well to look around at this point because it will – in a sense – be the calm before the storm. The companies which are working fervently now preparing themselves to be able to take their drugs all the way to commercialization are the ones who are going to step in to the fast lane when the first big approval comes. And as I said, I do think that the next five years is a very realistic timeframe for this to occur.

[The above was a brief excerpt from the podcast]

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The Greatest Challenges in Cell Therapy Today

Joining us in this Cell Therapy Bioprocessing & Commercialization Podcast is Jeff Karp - Associate Professor of Medicine at Brigham and Women's Hospital, Harvard Medical School. Jeff talks about the challenges facing the cell therapy space, how to improve cell homing following transplantation, and control cells among other things.

Listen to the Podcast | Access the complete transcript

What are some of the greatest challenges in cell therapy today? 

I think that we’re getting to a point in time where we can obtain almost any cell type in unlimited quantities with a few exceptions. This is using reprogramming, programming, different differentiation, protocols that have recently been worked out. So, I really think we are getting to that point where we can obtain nearly any cell type that can then be delivered to patients for treatment. 

While I think we’re there, I think one of the greatest challenges that remains is that once we transplant cells, we lose control over the cells. So, when we’re working with cells in a Petri dish, for example, we can pattern the media, we can put cells on all different types of textured substrates, we can control the media and the environment exquisitely. But, when we transplant cells, they are entirely at the mercy of the biological. So, if they end up in different tissues in the body, they are going to behave completely differently. So, we lose control of those cells following transplantation.

So, I think one of the greatest challenges is how can we now take the cells that we worked so hard to derive in vitro and then transplant those cells into patients and exhibit control so that the cells get to the right location and can perform their function when they get there.

[The above was an excerpt from the podcast]

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Accelerate Your Path from Concept to Product

Learn to how to apply the cost-effective and efficient strategies you need to advance your cell, gene and immunotherapies towards commercial success by attending IBC's Cell Therapy Bioprocessing & Commercialization meeting, held September 30 - October 2, 2015 in Alexandria, VA.

Secure your seat today to attend this year's meeting and learn alongside fellow developers and end-users as you collectively share ideas, solutions and lessons learned to:

• Accelerate your path from concept to product by applying insightful and relevant strategies from 80+ industry thought-leading speakers across 7 focused tracks >> Download the brochure 
• Stay at the forefront of innovation by evaluating new technologies and cutting-edge data in the exhibit and poster hall 
• Jump start collaborations and partnerships through networking luncheons, private exhibit hall tours, evening cocktail receptions, interactive panel discussions and more 

New! All registered attendees gain access to Attendee Connect, the networking tool to make connecting with new customers and partners easier than ever before.

"Cell and gene immunotherapies continue to develop at a rapid pace. IBC continues to grow with this promising field. I will be back in the future!" - Prentice Curry, VP of Quality & Operations, Kite Pharma

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