Update on Japan's New Cell Therapy Regulations

By: Leah Kinthaert

At the Cell Therapy BioProcessing Pre-Conference Symposia for the BioProcess International Conference and Exposition, VP of Business Development for RepliCel and cell therapy industry thought leader Lee Buckler updated the audience on Japan's new cell therapy regulations. Buckler was a great person to give insight into these new regulations, because RepliCel is partnered with a Japanese company.

The regulatory environment for cell therapies changed greatly in 2012 when Shinzo Abe was elected prime minister. Last year Abe (who has since then been re-elected) set a plan in action to change the existing regulations and provide $1 billion in stem cell research funding over the next 10 years. This political and economic driven regulatory innovation has created a market push into Japan; Buckler described how his company re-prioritized Japan into their strategy due to this seachange.

Japanese companies are actually getting overt recommendations from their government to go into cell therapies; the government has incentivized companies to locate in Kobe, where the Kobe Biomedical Research Center is located. Buckler stated: "One can't underestimate the power of government to influence corporate decisions. CEOs feel the need to respond to government presence."

Buckler went on to give details about his company RepliCel's research in Japan. RepliCel has partnered with one of the world's top hair care and cosmetics companies, Shiseido. Shiseido has built their own manufacturing facility in Japan, making RepliCel one of just two companies with a cell manufacturing footprint in Japan.

Buckler ended his lecture by asking the audience to ponder this question: "Over the long term, will it (changes in Japanese regulations) have real lasting commercial implications?"

The agenda for the PreConference Symposia on Cell Therapy Bioprocessing on Monday, October 26 can be found here.

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State of the Cell Therapy Industry 2015: Approvals, Funding and the Future

By: Leah Kinthaert

At the Cell Therapy BioProcessing Pre-Conference Symposia for the BioProcess International Conference and Exposition, the packed room was treated to two "Where are we now in cell therapy" analyses which gave an excellent examination of the current state of the industry, and provided predictions and suggestions for a successful future.

Kirk Trisler, Principal at Dark Horse Consulting, opened the event with an extensive overview of the current landscape in cell therapies, going through cell therapies that have been approved and examining who the players are for cardiology, oncology, neurology, diabetes, and opthamology.

Tisler presented two helpful maps, one showing "Cell Therapy CMO Options in Europe" the other "Cell Therapy CMO Options in the US". The US map showed that the "only options for Phase III" in the US are WuXi, Lonza, PCT (one in CA, one in NJ), UC Davis, Temple, Stanford, City of Hope, and U of Iowa.

Tisler then went through a list of all cell therapies that have been approved. They are: Provenge by Dendrion; Lavir by Fibrocell; Holoclar by Chiesi; Chondrocelect by TiGenix; Carticel by Genzyme/Vericel; and Apligraf, Dermagraft and Ginutiut all by Organogenisis.

Chris Gemmiti, Business Development Lead, Wyss Institute - whose discussion was titled "State of the Industry - From Fund Raising to Partnering to Adoption and Commercial Success" - continued on the track of giving an overview for the current cell therapy space. He said that there has been over three billion dollars in federal funding for regenerative medicine over the last three years. Financing for cell therapy companies in the first half of this year alone is over seven billion dollars, with an additional eight billion in milestone payments.

Gemmiti then went on to talk about the companies who have been funded this year: including Semma, Voyager, Dimension, Unum, Regenxbio, and Audentes. "Look at Semma," he said "(they got) $44 billion in funding and they're not even at the IMD stage."

He continued with more helpful stats:

• There are 580 regenerative medicine companies worldwide
• There are 72 approved products

Gemmiti closed his presentation by cautioning the audience: "Market caps are great but they have to translate to revenue in the real world...Just having approvals and a large market cap doesn't mean commercial success."

The agenda for the PreConference Symposia on Cell Therapy Bioprocessing on Monday, October 26 can be found here.

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Innovations in Single-Use Technologies: Mario Philips of Pall

By: Leah Kinthaert

BioProcess International Magazine had a great interview with Mario Philips, President, Single-Use Technologies at Pall Life Sciences, earlier this year. Pall is the sponsor for the Cell Therapy Bioprocessing Pre-Conference Symposia at the BioProcess International Conference and Exhibition happening Monday, October 26 in Boston. What follows are some of the highlights of the conversation between Philips and BioProcess International Magazine’s Publisher Brian Caine.

In some ways, you could say Mario Philips’ career came full circle when his company entered the cell therapy market. A chemical engineer by trade with some time spent in the biopharma industry, the 2000s found him working in the semiconductor industry at a company called ATMI. Philips said: “The semiconductor industry was facing the challenge of molecular and particle contamination when cleaning the stainless steel containers used for transportation…So we developed a bag-in-a-bottle and a bag-in-a-container system.” A friend gave him the idea to translate what they were doing to the life sciences. So he set out to become the leader in SUT (single use technology) by asking customers what was not yet addressed by the current technology. The connection with cell therapy comes from the fact that Belgium, where he lives, has a comparatively large biotech industry. Not many equipment manufacturers saw cell therapy as a promising business model - but his company at the time did.

Philips brings that thought leadership and innovation to Pall, where his goal is to bring cost-effective technologies that help “companies get more out of their R&D related technologies and help them either scale out (for autologous therapies) or scale up (for allogeneic therapies).”

Caine asked Philips to describe exactly what making those technologies cost-effective would entail: – “For autologous therapies…the goals are to close up the process and develop industrial scale automation…For allogeneic therapies…the goals are to close up the process, reduce the risk, and bring in some controls.”

Caine then asked why Pall was entering the cell therapy market when so many other companies are waiting for a return and “a bit more clarity in the market”.– Philips’ responded: “At Pall we believe it is a risk, but it is a more calculated risk, and we want to be first-to-market with this platform.”

Caine: Where do you see yourself as a leader in the cell therapy market and what products does Pall have to support that? Philips answers: “I think we have a strong position in what I call the expansion step of the cells. We have more product development in what I call the volume reduction step. Then we want to leverage expertise from our current business – one such area is process development....The second area that we want to leverage is our internal biopharma automation and process group. We build large chromatography skids. We set up complete single-use suites with the bioreactor in the middle and the mixers around it. We are building the expertise to connect these great products into a real platform solution. So I would say our focus is currently on industrial manufacturing, helping customers out of a relative crunch that they are in.”

The agenda for the PreConference Symposia on Cell Therapy Bioprocessing on Monday, October 26 can be found here. You can find the complete interview with Philips here.

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"Think Beyond a Single Batch" says Nick Timmins' of CCRM

By: Leah Kinthaert

On October 26, Nick Timmins, Director of Product and Process Development at CCRM returns as a speaker at the BioProcess International conference in Boston. For a preview, here's a brief recap of the highlights from his half hour discussion at the recent Cell Therapy Bioprocessing & Commercialization event held just a few weeks ago in Alexandria, Virginia. The title of Timmins' lecture was: "Solutions to Process and Technology Bottlenecks."

Process Bottlenecks and Technology Gaps – Timmins started his talk off with the pronouncement that he should call his lecture "Process Bottlenecks and Technology Gaps".  He explained: "We tend to throw the term bottleneck out there without really using it in the right context, at least not the context that is formally taught, an engineering-type context." If you have a technology gap "you need to create a new solution. If you have a bottleneck you can always add more capacity, up to certain limits."

Bottlenecks can cause an accumulation of inventory – The beginning of Timmins' talk focused on defining bottlenecks in cell therapy. He describes one of the major pitfalls of a bottleneck: "If you spend a whole lot of effort running at maximum capacity, you're going to get an accumulation of inventory. Inventory costs money. In our case (cell therapy) inventory is often labile. Cells sitting in a hold step...is doing bad things to your cells."

Think beyond a single batch –  Timmins cautioned his audience "to think beyond a single batch" because "as we move beyond commercialization and industrialization, plant and equipment utilization becomes very important" and a "major component of costs."

About Nick Timmins – Nick received his PhD in Chemical Engineering from The University of Queensland, Australia, specializing in novel methods and applications for 3D multicellular spheroids. Nick is the Director of Product and Process development at CCRM. Nick’s previous work experience includes Team Leader, Cell Therapy for the Australian Institute for Bioengineering and Nanotechnology (AIBN) at The University of Queensland. In this role Nick was responsible for the bioprocess development for clinical scale manufacture of blood products from haematopoietic stem cells and process scale-up and automation of mesenchymal stem cell manufacture. Prior to this, Nick completed his Postdoctoral Fellowship at the Tissue Engineering Laboratory, ICFS at the University Hospital Basel in Switzerland where he designed and developed a bioreactor for 3D cell culture and tissue engineering, a joint industry/university project.

Timmins will be speaking at the PreConference Symposia on Cell Therapy Bioprocessing on Monday, October 26. More information can be found here.

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[WEBINAR] Single-Use Equipment Extractables Testing: A Look Forward

With the continued adoption of single-use equipment for the manufacturing of biopharmaceuticals, the discussion on how the industry should handle extractables testing has been prevalent.

Register today to attend GE Healthcare's webinar, Single-use equipment extractables testing: a look forward, and learn about the industry’s progress towards creating a standard for the design and execution of extractables studies for single-use equipment.

The webinar also attempts to place the discussion into a wider context. Assuming the industry adopts such a standard, what problems would this solve and what are the next questions the industry should consider for collaborative discussions and resolution?

Reserve your seat to attend the webinar, held on Tuesday October 6, 2015 during the following three times:

• 10:00 AM EST | Register
• 1:00 PM EST | Register
• 4:00 PM EST | Register

The webinar will be approximately one hour in duration, which includes a live Q&A with the webinar speaker, Dr. Jeffrey Carter, Strategic Projects Leader, Bioprocess Divsion, GE Healthcare Life Sciences.

Space is limited, so reserve your seat today.

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Single-use technologies enable closed-system bioprocessing

The benefits of single-use technology

Single-use technologies provide a number of benefits over traditional hard-piped equipment and facilities. Five key benefits are described below:

1.    Increased flexibility which allow system changes to be readily implemented during process development, scale-up or while a process is in routine operation.

2.    Reduced risk of contaminations either between batches of the same product or between batches of different products manufactured in the same facility

3.    Reduced or eliminated need for steam-in-place and clean-in-place generating equipment

4.    Shorter facility start-up time

5.    No need for cleaning validation

However, an additional benefit that is attracting an increasing amount of attention is the utilization of single-use technologies to allow closed-system processing.

Why perform closed system processing?

Closed-system processing in single-use technology might be an attractive option for a range of biomanufacturers with different motives. These could include:

·         Cell Therapy manufacturers operating short and simple processes with no method of sterilizing their end-product

·         Vaccine and viral vector manufacturers who find that sterile filtration processes significantly reduce process yields of these large biologics

·         Continuous manufacturers operating processes for many weeks at a time and wanting to avoid a build-up of bioburden within their equipment

·         Any biomanufacturer looking to cut facility running costs by reducing the air handling requirements within processing suites

·         Small-scale, localized, temporary bioproduction facilities manufacturing vaccines close to outbreaks of infectious diseases where local infrastructure is limiting.

Single-use developments allowing for closed-system processing

Pre-irradiated, assembled manifolds and containers are available from a range of suppliers. Operators simply need to install the product-contact consumable and are then ready to start processing.

Single-use bioreactors have been available for some time and are designed, of course, to minimise the risk of microbial ingress. Similarly, single-use mixers and bioprocess containers can be connected to and from with sterile connectors. Sterile disconnectors allow ancillary tubing to be removed while maintaining a sterile boundary around the product. Thermoplastic elastomer tubing can be welded to create flowpaths without compromising sterility and can be sealed to close containers.

The sterilization of product streams and necessary process solutions such as culture media and buffers can be achieved using gamma-irradiated membrane filter capsules. Remember, however, that simply used a sterilizing-grade filter in itself does not guarantee sterility and that validation of the sterile filtration process must be performed to ensure a bioburden-free environment.

For a while, closed-system processing was held back by a lack of suitable technologies for the purification of biologics largely because the need had not been identified or the technology not available. The company I work for has now launched a single-use TFF which avoids the need to clean and store cassettes. At a conference I attended last week Dr James Rusche, Senior VP Research & Development at Repligen described a single-use Protein A chromatography column that had been gamma-irradiated to prevent the build-up of bioburden during continuous harvesting operations.

Of course, because a technology can be gamma-irradiated does not mean it is qualified as sterile, however, if the drivers are there then customers will push vendours to generate this data for all single-use technologies allowing closed-system processing to become a reality for a growing number of processes.

Have your say

Are you driving towards closed system processing? What technology would, if available, make operating in this way more feasible?

Want more on single-use technologies? Meet leading companies in the space at BioProcess International Conference & Exhibition this fall in Boston. Here are the sponsors and exhibitors that will be attending:

Eppendrof
Finesse Solutions, Inc.
GE Healthcare Life Sciences
JSR Life Sciences
Levitronix,
Meissner Filtraion Products
Optek-Danulat Inc.
Qosina
Repligen
Saint-Gobain
SpectrumLabs.com
Pneumatic Scale Angelus
ILC Dover
CPC
Pall Life Sciences
TEK
Nordson Medical
Thermo Fisher Scientific
Beckman Coulter
em-tec Flow Technology (LP)
Kuhner Shaker Inc.
Entegris
WR Grace

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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BPI 2015 Final program just released!

BPI is engineered to be exactly what YOU need it to be. Formal and informal networking experiences connect you to peers, prospects, and customers. Parallel tracks give you the option to dive deep or take a big picture approach to learn about industry trends, challenges, and benchmark against the latest research developments. Big pharma and large, mid-size and emerging biotechs collaborating with solution providers featuring proven and next generation technologies make BPI a one-of-a-kind meeting place.

Bioprocess International
Conference & Exposition
October 26-29, 2015
Hynes Convention Center
Boston, MA

Download the brochure here: >>> http://bit.ly/1K9ELmX
Use code XB15171BLOG for $100 off the current rate.

The Most Comprehensive Science: Capitalize on the latest data-driven research and moderated discussions to move towards commercialization and streamlined development and production from upstream to drug product/fill-finish. 

The Most Innovative Technologies: Accelerate speed, efficiency and ROI across a global network by evaluating innovative and proven products and services at the industry’s largest exposition.
 

The Right Partners for You: Form collaborations and alliances with innovators, suppliers, academia and associations to reach new heights of clinical and commercial success. 

Gain Access to 6 Conference Tracks with 1 Registration Fee:

• Cell Culture & Upstream Processing;
• Recovery & Purification;
• Manufacturing Strategy;
• Analytical, Formulation and Quality;
• Drug Product Manufacturing & Fill-Finish Processing;
• Early Stage Biologics and Early Stage Companies.   

 Meet the People Behind the Products and Get the Answers You Need!

In the largest exposition hall devoted exclusively to biopharmaceutical manufacturing, attendees will learn about the latest technologies and services developed to overcome challenges and streamline processes. Network and consult with the experts from product and service provider companies.

Download the brochure to learn more: >>> http://bit.ly/1K9ELmX

Register by Friday, June 12 to Receive Up To a $500 Savings
Your Savings Code = XB15171BLOG

Register now to save up to $500 here >>> http://bit.ly/1demU18

Group Rates Available for Companies Registering 4+ Attendees.
Call Millison Thenor directly at 646-895-7423.

*Discount is valid for new registrations only and cannot be combined with any other offer.

Best,
The BPI 2015 Team.
@IBCBioProcess
#BPIconf
www.IBCLifeSciences.com/BPI

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Earn a FREE Pass to the Bioprocess International in Boston, MA – Become a Guest Blogger!

Earn a complimentary all-access pass to Bioprocess International Conference & Exposition by serving as a Guest Blogger at the event. As a Guest Blogger, you’ll have access to the Bioprocess International event’s comprehensive agenda attracting the best insights from around the world, right in Boston, Massachusetts in October.

Bioprocess International

Conference & Exposition

October 26-29, 2015

Hynes Convention Center, Boston, MA

We are looking for an industry expert with interest in the following topics:

• Drug Product Manufacturing & Fill-Finish Processing
• Cell Culture & Upstream Processing
• Recovery & Purification
• Manufacturing Strategy
• Analytical, Formulation and Quality
• Early Stage Biologics and Companies

...and who would like to learn about the future trends in bioprocessing!

The premise is to provide Bioprocess and Life & Science related articles, whitepapers, and overall original content with a strong focus on a whole bioprocessing industry from product development to biomanufacturing.

What You get is:

• FREE pass to the conference (valued up to $2,399);
• Access to extensive social learning activities;
• Exclusive admission to a networking community in the industry of your interest!

You also have a chance to GAIN exposure through our five health related-blogs with over 2000 unique visitors monthly each and more than 20 healthcare LinkedIn groups.

Learn more about the Bioprocess International Conference & Exposition event by visiting our website.

Interested & want to learn more about this opportunity? Please contact Krista Lentini at klentini@iirusa.com or call 646 895 7316. Feel free to share your short biography, links to your blog or writing samples, along with a few sentences about why we should choose you to become the Guest Blogger for Bioprocess International Conference & Exposition 2015!

 

We hope to have you join us in Boston!

Cheers,

The Bioprocess International Team

@ibcBioProcess

#BPIconf

Visit the website: http://www.ibclifesciences.com/BPI/overview.xml

Future of Biopharma Blog http://futurebiopharma.blogspot.com/

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#BPIConf: Six Insights on BioProcess Manufacturing Innovation

On the first day of BioProcess International, we were able to sit in on 3M™'s full day symposium Innovation through Integrated Process Development.

Here were our six of our take aways:

• 1. Rob Piper, Principal Scientist, Amgen on the strengths of using disposables: low investment, small footprint, single/quick expression, short implementation time, reduced qualification/maintenance and fast passed product of change
• 2. According to Abhinav Shukla, Ph.D., of KBI Biopharma, mixed mode chormotography: examine and incorporate modulators into process that can help increase selectivity and purity of a product.
• 3. Kumar Dhanasekharan, Director of Process Development of Cook Pharmica emphasized that continuity in process development as should be developed and scaled as production occurs through the different phases.
• 4. 3M recently conducted the web seminar 3M™ Innovation: Transforming and Redefining Biopharmaceutical Purification with 3M™ Emphaze™ AEX Hybrid Purifier – which was discussed throughout the day in the track. See the web seminar here.
• 5. Rahul Singhvi, Ph.D, MSc., COO, Global Vaccines Business Unite, Takeda Pharmaceuticals brought a different perspective to the table. He challenged production innovators to take a new approach to manufacturing tried and true vaccines the access to childhood vaccines is not reliable, accessible or affordable enough.
• 6. Holistic approach to biopharmaceutical development – this should lead to a higher performances with lower cost of manufacturing processes.

Stay tuned to #BPIConf to follow along with today's events and check back for more highlight posts throughout the event!

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