Cell therapy manufacturing service – companies overview

by Alexey Bersenev on October 27, 2008 · 5 comments

in business

If you’re a hematologist or oncologist and need to transplant cells in your patients to keep them alive, you may need a service for graft processing that your hospital can’t provide often. Of course, some hospitals have so-called “bone marrow processing lab”, with some devices that allow to deplete red blood cells and platelets. But what if you need to customize your graft or create a new one, playing with different cell populations in sterile clinical-grade conditions?

I’d like to overview some companies which provide service for cell therapy – cell processing and manufacturing. They are not selling cell products, but they are providing a service.

These companies can provide you with solutions to start up your business in regenerative medicine, develop your own unique cell product and bring it from bench to market.

All of the companies are USA-based and use a set of standards – GMP/GTP/GLP.

let’s look what kind of services you can get today:

Cognate Bioservices Inc

Company provides number of services:

– cGMP manufacturing
– preclinical and clinical product development expertise
– cell product assay development (in vitro and in vivo tests and analysis of quality of the product)
– stem cell services – customized Production of: Human mesenchymal stem cells derived from adipose tissue, Human mesenchymal stromal / stem cells derived from bone marrow, Adipose-derived stem cells, bone marrow stromal cells, and fibroblast control cells from a variety of animal species
– commercialization of cell-based products consulting –
regulatory service and support (preparing IND according FDA requirements), process development (cost-effective solution for product development and clinical phase planning)

Progenitor Cell Therapy

Besides contract manufacturing, consulting and stem cell banking and transport, Progenitor Cell Therapy has some unique cGTP services:

– Cryopreservation and storage
– CD34 cell selection
– T cell depletion
– Red blood cell depletion
– Plasma depletion
– Donor leukocyte preparation
– Umbilical cord blood processing
– Bone marrow & peripheral blood progenitor cell processing
– Flow cytometric analyses
– Polymerase Chain Reaction
– Microbial assays
– Blood typing
– Infectious disease testing
– Functional assays (colony assay, cytolitic T-cells, cytonike production)


Lonza works with Organ and Tissue Procurement Organizations, hospitals and private physicians in the U.S. to collect tissues within the framework of the AATB standards and FDA regulations for manufacturing processes for clinical use.

What type of cells have you worked with?
Fibroblasts, keratinocytes, renal cells, umbilical cord cells, vascular endothelial cells, dendritic cells, myoblasts and mesenchymal stem cells are among the cell types with which we’ve worked.

finally, one more company, provided GMP/GTP/GLP contract cell product manufacturing around US – AppTec

I hope this information will be useful for you and help to develop your cell therapy business or customize a graft for your patients.

picture credit: Lonza corp.

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  1. Cell therapy manufacturing costs – calculation by Lee Buckler

{ 5 comments… read them below or add one }

Lei November 11, 2008 at 8:40 pm

This bussiness seems promising. But I wonder how many cell-based therapy clinical trials other than hematopoietic stem cell transplantation have reached Phase III.


Alex November 12, 2008 at 2:32 pm

to Lei –
Prochymal – the product of Osiris Therapeutics reached phase III in 2 diseases –
Crohn’s Disease – http://www.osiristx.com/clinical_trials_prochymal_crohns.php

Prochymal is allogeneic mesenchymal stromal progenitors from bone marrow

In my knowledge Osiris is the only one adult stem cell company which reached phase III


Alex November 12, 2008 at 3:01 pm

I just wondering how much money contract manufacturing can bring itself?
is it profitable at all? Or going to be some kind of additional service/business for big companies like a Lonza?

somebody know the answer? Can’t find a companies annual reports, these press-releases suppose to be on the web-sites


Jon Rowley November 13, 2008 at 6:10 pm

Hi Alexey,
Thanks for pointing me to this great overview. As I am an employee of Lonza, I can’t offer much ‘opinion’, but I can point you to some further info on this subject.
1) as for how much money is to be made in contract manufacturing, Lee Buckler has outlined this at his blog. check out: link

2) Lonza offers a much wider range of services other than just tissue acquisition, which includes custom media development, process development and manufacturing at all scales. Check out think link
Also, a good overview of Lonza Cell Therapy was published in the journal RegenMed early this year:

3) Florida Biologix is also providing these services to earlier stage Phase I cell therapies:

Thanks for the interest in this aspect of cell therapy, it is an important one.


Lee Buckler November 19, 2008 at 3:46 pm

Useful overview Alex. This is pretty much the list of the US corporate CMOs. There are also academic centers, of course, which outsource their development and manufacturing services. Additionally there are CMOs and academic centers in Europe and Asia which do the same.

To address Lei’s point, my best data shows there are 30+ registered phase III or pivotal industry-sponsored cell therapy or cell-mediated gene therapy trials currently ongoing (see http://celltherapyblog.blogspot.com/2008/11/how-mature-is-cell-therapy-industry-do.html). This excludes all the academic trials and any trials in jurisdictions where such trials are not formally reviewed by a regulatory agency.



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