Showing posts with label Cell Therapy Bioprocessing and Commercialization. Show all posts
Showing posts with label Cell Therapy Bioprocessing and Commercialization. Show all posts

Wednesday, October 21, 2015

"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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Thursday, October 1, 2015

Automation should support a 'clear vision for commercial viability' - Brian Hampson


Brian Hampson: automation must support a clear vision for commercially viable manufacturing

By Brian Caine

“Companies must understand that automation should support a clear vision for commercially viable manufacturing and is a tactical approach to support a strategic end,” Brian Hampson ME, vice president of manufacturing development and engineering at PCT, a Caladrius company, told attendees at Cell Therapy Bioprocessing & Commercialization.

Hampson has more than 20 years’ experience in the cell therapy industry and has first-hand experience in the evolution and progress being made within the cell therapy development process. He said that “automation strategies vary with fundamental differences of product”, pointing out several factors need to be considered including:
  • Development by design, as defined by quality – COGS – scale and sustainability
  • Should consider needle-to-needle scope
  • Managing comparability risk
  • Automation must be part of a comprehensive strategy
  • Automation considerations:

He also pointed out the many types of automation to consider:
  • Process automation (closed-loop process control)
  • Task automation 
  • Test automation
  • Factory automation
  • Information:  electronic batch records
  • Execution: manufacturing execution system (MES)

He stressed that “automation must be planned in the context of opportunity and value”. “We all talk about doing everything early, but automation can have a dark side to it,” he said. “You need to be sure what is going on inside the process.”

He warned that automation can also create its own problems, including process black box effect, supply chain risk, complexity, cash and timeline sink, comparability risk and unmitigated automation failure.

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GE Healthcare's Vanek: 'a mature cell therapy market is coming'

Philip G Vanek PhD said cell therapy is moving closer to a mature market


GE Healthcare general manager of cell therapy technologies Philip G Vanek PhD told attendees at Cell Therapy Bioprocessing & Commercialization that industries evolve down similar tracks: discovery, development, manufacturing.

“The biology of CTs has happened, process development and optimization is currently happening, a mature CT market is coming,” he said. However, he stressed the need for bespoke tools, "to design equipment that will be needed in the future”.

He pointed to five key areas that need development:
  1. Connect unit operations – increase the use of closed systems to increase repeatability
  2. Drive towards automation – decrease human interaction and involvement
  3. Contain costs per unit
  4. Manage talent – with scale comes need to more trained staff
  5. Risk management
What areas do you think need focus?

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Wednesday, September 30, 2015

"Help me to help you" NIH program director Rosemarie Hunziker tells Cell Therapy attendees

Rosemarie Hunziker
By Brian Caine

NIH program director Rosemarie Hunziker told attendees at Cell Therapy Bioprocessing & Commercialization 2015 that there is a “ton of grant money looking into new therapies”.

She said that companies must be able to articulate and document the product development life cycle in order to access these funds and that different agencies looked at different criteria.

“The grant that works for one agency doesn’t work for another,” she said “We all have different cultures."

Hunziker also stressed that manufacturing platforms “must evolve”. “While discovery is critical if you don't move it into commercialization it will stay in a lab forever," she told delegates in her session called “Show me the money”.

“While discovery is critical if you don't move it into commercialization it will stay in a lab forever" - Rosemarie Hunziker, NIH


In many cases “the financials to produce enough cells cannot be supported economically,” she said “Platforms must become more efficient if cell therapies are going to treat a broad patient-base.”

The industry as a whole agreed that there needs to be an evolution towards therapeutics. “The challenges are quite significant," she said. Overcoming these will allow a shift from "boutique treatments to ones deliverable in a clinic".

The NIH has invested more than US$3bn in the past three years, mainly in research Hunziker said. However, she added that the NIH was moving towards “promoting sciences and engineering grants looking at the key manufacturing roadblocks.”

“Help me to help you,” she said. "When you put the right money in the right place you can have some pretty profound impact"

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Plenary Sessions Pave the Way for "Cure Not Treatment"



By: Brian Caine

Cell Therapy Bioprocessing & Commercialization got off to an exciting start as plenary speakers Marc Better PhD, Julie Alllickson PhD and Bruce Levine described the cell therapy landscape and their outlined progress.

More than 200 cell therapy professionals heard Dark Horse Consulting president and event chairperson Anthony Davies set the stage by reviewing the real progress and strides the cell therapy market has made while acknowledging the hard work that the industry is facing.

Marc Better, Phd, Vice President, Product Services at Kite Pharma kicked off the first of three presentations describing the market as "exciting and challenging". He outlined the general challenges faced by Kite Pharma and focused on the solutions it implemented to effectively and successfully engineer autologous T cell therapies.

Julie Allickson, PhD, Director, Regenerative Medicine Clinical Center, Wake Forest Institute for Regenerative Medicine said real commercialization would come as research moved to "cure, not treatment".

She provided attendees with Wake Forest’s approach to determine what process design, development, manufacturing, and technologies will best support their initiatives.

"Academic and industry must come together in order to be successful," she said to create "a manufacturing roadmap for TERM Technologies".

Allickson reinforced the need to create a consortium to develop infrastructure and resources to advance manufacturing and set a standards. She also noted that bio-printing is showing greta results and has a bright future.

Bruce Levine, PhD, Associate Professor in Cancer Gene Therapy, University of Pennsylvania detailed their approach to targeting tumors with CAR-modified T-Cells and reported on the positive short and long term results.

Join the conversation on Twitter by following #IBC_CTB15


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Wednesday, September 2, 2015

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).


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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