Progentior Cell Therapy

From Bench to Market: Advancing the Field of Cellular Therapy

Our quality product service solutions bridge the gaps between technology and patient care by providing custom-tailored cell therapy services, including:

  • Contract Manufacturing
  • Product & Process Development
  • Consulting
  • GTP Services
  • National Distribution
Men standing around talking
 

Below is a snapshot of some of the commentary we've received:

"There is no question, as far as I’m concerned, that our alliance with PCT has had an an appreciable impact on sales. It has exactly the impact I thought it would have from the day I read about PCT. I’m still excited about it as you can probably tell." Note from client Director of Consumer Sales.

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"I hope you had a smooth trip home. The team really appreciated you attending the meeting and found both your talk and input to [our] training of tremendous value. A huge thanks and great start of our relationship." Note from a division leader of a multinational client.

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"This is good -- very helpful comments. You've taken it to the next level which amongst other things identifies deficiencies and forces resolution of outstanding issues." Note from client Vice-President Research & Development.

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"These are exciting times and we are so fortunate to have partnered with such a fine organization." Note from client Vice-President.

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"Many thanks for your very detailed report. I may give you a call next week if questions arise. Are you comfortable with me sharing this report with the Company? I believe they would greatly benefit from your knowledge and recommendations." Email to PCT from the director of a venture capital client re: our assessment and report on a portfolio company

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"We are very grateful for the outstanding work you and PCT did for us. The 12 batches of high quality dendritic cells gave us a one year head start on our clinical study. Thanks again for all your help!"
Note to one of PCT’s laboratory project managers from a client 's clinical investigator with a Phase I trial

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"I spent about 4 hours in the clean room last night with PCT staff. I was fortunate to be able to observe 4 processes; the completion of a placebo with cryopreservation process and 3 active…processes. The operators for the 3 active processes were Kyle, Joshua, and Jamie. Kyle and Joshua are new operators (this was the 3rd process for each of them) and Jamie has been processing for about 3 months. Akram (supervisor) and Lester (other most senior mfg operator) were the verifiers. I think they did a fantastic job. What I found was, independently, all 3 operators were performing each step with incredible likeness. The processes were staggered by about 15 minutes so I was able to observe all the operators loading [ingredient], adding cell suspensions, re-suspending pellets, use of scales and centrifuges, and their aseptic techniques. Akram and Lester were very attentive, assisting and coaching along the way.

PCT manufacturing operators are performing [our] process in exact accordance with [our] procedures. This is another fine example of the thoroughness of your training program and commitment to supporting [our] clinical programs. Please pass along my gratitude to the staff for their outstanding performance. Their diligence and commitment to quality work for [our company] is truly appreciated."
Email from Client project manager after routine internal monitoring.

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"I just want to take this opportunity to congratulate the PCT production team on completing the [first of three] Large Scale Production of [cell product in process qualification at PCT]. The [Product name] cell harvest set a landmark yield of about [absolute number] viable cells. Both the harvest and the formulation at [concentration of cells/ml] in [cryopreservative], vialling, and controlled rate freeze process were also completed in reasonable time. We plan to have preliminary QC results next week to assess the quality of the cells. Good work by all. Give each other a big pat on the back."
Email to PCT from Client regarding its lead allogeneic, adherent, gene therapy cell product having completed technology transfer and currently in process qualification in preparation for Phase I clinical evaluation.

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“…what a week we've had. Your team has done a superb job to juggle all the activities and events associated with [the company]’s processing. Their efforts are tremendously appreciated and have been recognized by top management at [my company]… Thank you and your team for the continued support of [the company]’s clinical programs.”
Email to PCT from client’s program manager for its lead product currently in phase III clinical trial.

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Email to client and PCT project team from PCT President, Robert Preti: "Congratulations to all on your successful efforts to reach this exciting milestone along the product development pathway for [the product]. You should each and all be proud of the result and gratified that the teamwork and coordinated effort paid off to get the project to this point. Without your concentrated and singular focus, we would not be where we are tonight."

"Thanks Bob. I share the sentiment. Great work team. I am proud of you."
Email to PCT and client project team from client’s Vice-President, Research.

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"Checklists of documents and activities were generated to establish the quality and manufacturing requirements to move forward with the production of the Clinical Trial Material for Phase 1 studies at the Progenitor Cell Therapy Facility in Mountain View, CER Room [#]. PCT and [my company's] personnel have completed the required documentation and activities to initiate production of the Clinical Trial Material. PCT MV CER Room [#] is qualified to produce the Clinical Trial Material. I want to take this opportunity and thank the PCT staff for all their efforts in assuring that all activities and required documents were in place in time to allow [my company] move forward in production. It’s been a pleasure working with you."
Email to PCT from a client's VP Regulatory Affairs and Quality Assurance after facility qualification for its lead product curerntly in phase I clinical trial.

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“Your team did an absolutely stellar job this week. You had very high volume, 8 processes, a very late arriving [product] that [your staff] stayed to process which ultimately resulted in a successful product delivered to the patient, you dealt [with] endotoxin assay issues expeditiously enabling the release of two more patient products; in the face of all these hiccups - the patients received their products. Please extend my and [the company]’s heartfelt gratitude for the continued support of your team to consistently meet [the company]’s challenging clinical program needs. Have a great weekend, you all are more than due to it.”
Email to PCT from client’s program manager for its lead product currently in phase III clinical trial.

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“Congratulations for this great achievement!”
Email to PCT from a client’s Vice President of Regulatory Affairs and Quality Assurance upon successful completion of QA audit of PCT facility for production of client’s lead phase I clinical trial product.

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“Scientists, academics and key industry figures from across the UK are gathered in Newcastle today for a conference on developing the region’s stem cell economy. The event was organized by the Centre of Excellence for Life Sciences (CELS) … Delegates will hear a number of speeches, including a keynote presentation from Dr Stewart Craig, Vice President and Chief Technology Officer of California-based ‘Progenitor Cell Therapy’ (PCT) Inc. Mike Nicholds, Programme Director at CELS, said: “CELS is delighted with the success and growth of BioNEt, which now has the support of over 1000 research members and is continuing to attract guest speakers from all over the world. …. “Through our networks and events, we promote ourselves to companies all over the world, so that they know about the strength of our research base and how they can interact with our companies. The more they know, the more likely they are to invest the region.”… Dr Philip Aldridge of CELS is chairing the event. He said; “…The event will focus on ‘cellular bio-processing’ – looking at the technology required to get stem cell products to market, an area where CELS is developing plans to significantly enhance the region’s capability. Dr Stewart Craig is flying in from the States to share expertise from PCT Inc. – one of the world’s leading manufacturers of cellular therapies.”
Excerpts from a press release by the Centre of Excellence for Life Sciences (CELS)

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“We are making considerable progress at Dendreon, having recently announced promising Phase III data for ProvengeTM,” said Mitchell H. Gold, M.D., Dendreon’s chief business officer. “Progenitor has provided us with high quality cell processing through their Hackensack, New Jersey. facility, and we are confident they will continue to do so through this expanded relationship, which enables us to have the cell processing capacity we need going forward."

“This decision was made after a thorough analysis of our experiences to date in operating a Dendreon-owned facility versus contracting for services,” said Martin Simonetti, chief financial officer at Dendreon. “It makes sense both financially by lowering our cost of goods and strategically in the long-term commercialization of our products.”
Excerpt from a Dendreon press release August 2002