About us

The Cell Factory Identity and Mission

The Cell Factory activity focuses on two pillars:

  • Therapeutics development: Investigation and development of new therapeutic products in niche applications in regenerative medicine: “of-the-shelf” advanced biologics (extracellular vesicles) and autologous stem cells.
  • Technology development: Expanding of the technology platform, infrastructure, know-how and IP portfolio for manufacturing of extracellular vesicles, exosomes, and stem cell products for applications in regenerative medicine and diagnostics.

Our mission:

  • Bring the state-of-science and state-of-medicine to a new frontier and influence further advances in regenerative medicine and therapy.
  • Continue engaging in research and development of processes and technologies, which are directly influencing autologous stem cells and “off-the-shelf” EVs and exosomes use in therapy.
  • Develop affordable and accessible therapeutic solutions for unmet medical needs.
  • Constant improvement of production processes ensuring maximum yields, quality, purity, safety and low production costs.
2.1

Company overview

The Cell Factory is a full subsidiary business unitcompany of Esperite Group (Euronext: ESP). Esperite is, listed at Euronext Amsterdam and Paris. Esperite is a leading international company in biobanking, regenerative and predictive medicine since 2000.

The Cell Factory fully owns a patent family on broad applications of MSC-derived EVs and exosomes in treatment of various inflammatory diseases.

The Cell Factory is part of the Esperite group with over 10 years of experience in stem cells biobanking.

Access to Esperite’s build-for-purpose lab facilities (GMP/GLP) in Belgium and other Esperite’s international resources: legal, financial, regulatory, HR, marketing, logistics, IT.

The company has full rights for commercialization of the new IPs generated in the research projects sponsored by Esperite.

The Cell Factory has developed a proprietary production process of the highest quality stem cells and EVs with low and competitive production costs – production process is GMP-compliant (ISO/GLP) and ready for technology transfer and scale-up production.

One manufacturing process can be used for production of stem cells and EVs for multiple applications and different therapeutic targets.

Esperite and The Cell Factory have built an international network of the leading academic teams and clinical partners supporting pre-clinical research and clinical translation.

The Cell Factory’s staff are experienced scientists (PhD), medical professionals (MD) and technicians (MSc, BSc).

2.2

Strategy and partnership

The Cell Factory’s strategy focuses on development of the most promising ideas and technologies that emerge from fundamental science towards effective and commercially viable therapeutic products. The Cell Factory goal is to develop the selected drug candidates from a TRL 4 (non-GLP POC) until TRL 6-7 (Clinical phase II).

The Cell Factory is looking for partners and investors who are interested in supporting a development, clinical translation and commercialization of the new therapeutic applications of extracellular vesicles (EVs).

Out licencing:

Our company is looking for partnership and collaboration with the biotech companies and biopharma industry interested in investments in a rapidly growing, disruptive technology of EVs biological drugs. Our preferred model of the partnership is a non-dilutive funding provided to support a clinical development of the selected EVs products or the product lines based on the exclusive licence agreement.

In licensing:

The Cell Factory is searching the academic institutions and biotech companies interested in licencing and clinical translation of the new EVs products and technologies. Our preferred model is licencing or acquisition of the IP rights of the technologies at the TRL 4 (late stage TRL 3 is also acceptable). The Cell Factory specializes in GLP/GMP/GCP technology transfer and optimisation of the production process for subsequent clinical translation and large-scale production. The Cell Factory is interested in co-development of the EVs products, and generation of new IP, together with the licensing partner.

VC funding:

TThe Cell Factory, a subsidy of Esperite (Euronext: ESP) is also interested in a dilutive funding e.g. fixed price convertible bonds.

Research collaboration:

Our Company has been participating in several research projects including EU FP6, FP7 and H2020 grants, and several other national and international funding calls. An international network of The Cell Factory’s partners and collaborators plays a key role in successful development of the new therapeutic products and generation of new IP. Esperite’s company The Cell Factory sponsors an international consortium of the leading teams in paediatric regenerative medicine to bring EVs technology to the clinic with niche applications in treatment of acute and chronic drug-resistant epilepsy. The Cell Factory is interested in a joined application for the research funding together with the commercial partners, clinics and research institutes (academic and non-for-profit).

2.3

Market analysis

Allogenic off-the-shelf EVs therapies market:

Billions-worth market of stem cell therapies (ARM annual data report 2015) is largely using stromal/mesenchymal stem cells (MSC), with over 500 clinical trials worldwide. In most of the applications, the immunomodulatory and trophic capabilities of MSC are utilized.

2.4

It has been demonstrated that EVs secreted by MSC have similar immunomodulatory potential as the origin cells and can be used instead of MSC in therapy. Esperite’s The Cell Factory fully owns the patents family which covers EVs applications in treatment of all autoimmune, chronic and acute inflammatory diseases (among others):

  • Crohn’s diseases and ulcerative colitis,
  • rheumatoid arthritis,
  • inflammation of connective and vascular tissues (rheumatology),
  • autoimmune inflammatory disease,
  • systemic vasculitis,
  • giant cell arteritis,
  • Wegener’s granulomatosis,
  • Henoch-Schonlein purpura,
  • central nervous system vasculitis,
  • cryoglobulinaemia,
  • multiplex mononeuritis,
  • Takayasu’s arteritis,
  • Burger’s disease,
  • intestinal chronic inflammatory diseases
  • scleroderma,
  • Sjogren’s syndrome,
  • multiple sclerosis,
  • chronic autoimmune hepatitis,
  • primary biliary cirrhosis,
  • psoriasis,
  • alopecia areata,
  • vitiligo,
  • autoimmune haemolytic anaemia,
  • Addison’s diseases,
  • Type 1 diabetes and adult late-onset autoimmune diabetes,
  • sinusitis,
  • chronic bronchitis,
  • periodontal disease and diverticulosis
  • recurrent autoimmune diabetes in long standing diabetic patients after receiving islet or pancreas transplantation,
  • systemic lupus erythematosus,
  • dermatomyositis,
  • Goodpasture’s syndrome,
  • Guillame-Berre’s syndrome,
  • chronic glomeluronephritis,
  • dermatitis and eczema,
  • Reiter’s syndrome,
  • reactive arthritis,
  • cystic fibrosis,

Allogenic EVs clinical translation strategy:

The Cell Factory strategy of clinical product development and clinical translation:

  • MSC-EVs role as inhibitors of inflammation have been investigating for several years by different groups, including the inventors of the Patent owned by Esperite. MSC-EVs efficacy as anti-inflammatory agents has been confirmed in multiple in vitro and in vivo models up to date.
  • In 2015 The Cell Factory have developed clinical-grade (GMP) process of ultra-pure MSC-EVs bioproduction in fully defined media. MSC-EVs production process is at least 10x more efficient and cheaper when comparing to MSC equivalent.
  • The Cell Factory has established a consortium of the leading teams in the field of EVs with the goal of development and clinical translation of EVs (described below).
  • Product development is now in a preclinical phase. We expect the product will be ready for “first-in-man” clinical trials in 2017.

Key focus of the EVs product development:

  • Preclinical testing of the clinical-grade EVs manufactured at The Cell Factory according to GLP/GMP guidelines. We are not testing research-grade products. The priorities are: efficiency, reproducibility and low cost of goods.
  • Bioproduction of MSCs and EVs for preclinical tests and development are performed according to GLP/GMP guidelines and using GMP-grade reagents and devices. All production process is based on 100%-defined media and reagents with no use of animal-derived products, sera, human platelet lysates etc.
  • Standardisation of the EVs product quantification, characteristics and purity.
  • Investigation of mode of action (MOA) in vivo and development of potency tests in vitro (in particular to confirm immunomodulatory properties of EVs).
  • Regulatory requirements for clinical translation of EVs (EMA, FDA, EU national regulations).
  • EVs labelling, bio-imaging and bio-distribution at subcellular level and tissue/organ level.

This approach will significantly increase the clinical and commercial success of the EVs product and reduce the development time and cost.

Moreover, this strategy will pave a way for the new EVs products, which are currently developing for other indications in neuro-inflammatory diseases and beyond.

EVs bioproduction in 3D culture system

Autologous stem cells therapies:

We expect that an investment in development of clinical applications of autologous perinatal stem cells (cord blood and cord tissue) will have a significant impact on CryoSave biobanking business in the near future. Investments in autologous advanced therapies using perinatal cells will benefit with broader offer of experimental therapies available for the clients in a long-term.

The main advantage of perinatal stem cells is their young age and genetic and epigenetic quality. These make autologous perinatal stem cells a unique starting material for new technologies in regenerative medicine e.g. tissue engineering and cell reprogramming. The key advantages of perinatal cells, when comparing to the cells derived from adults are:

i) low level of genetic mutations accumulating in the lifetime,
ii) easier and more efficient reprogramming process,
iii) less epigenetic changes accumulating in the lifetime,
iv) faster and more efficient cell expansion.

MSCs in 2D culture system
MSCs in 3D culture system