Filling Techologicaland Therapeutics Gaps

Rigenerand wants to develop and produce innovative products for pre-clinical and clinical applications of cell-based technologies for regenerative medicine and oncology.
Our philosophy is driven by the need to fill gaps in cell manufacturing based on novel biomedical devices that conjugate safety, low cost of manufacturing and a progressive automation. Simultaneously, Rigenerand aims to fill therapeutics gaps for still incurable cancers, such as pancreatic adenocarcinoma, by manufacturing smart treatments based on gene-modified effectors redirected against cancer.

MainTechnologies

Rigenerand BioDi

Rigenerand BioDi develops and produces technologies for ex-vivo application of human cells for diagnostics and therapeutics

Rigenerand Thera

Rigenerand Thera generates products based on gene-modified effector cells for cancer treatments

Biodisposable

Rigenerand owns proprietary technology that allows more efficient ex-vivo stem cell cultures for safer cellular therapies.

Rigenerand develops & produces biomedical tools to empower the ex-vivo phase of cells culture combining the need of high cell yield with innovative biocompatible materials.

The isocult platform

Our unique bioreactor platform defined as ISOCULT (Integrated Space Optimized Culture-System) has been developed to support 3D tissue-like cultures to amplify human cells starting from either cell lines or primary collected cells from patients, including cancer cells and stem cells.

The ISOCULT technology provides three different application solutions

FEATURES

  • Closed and safe system
  • 3D integrated matrix
  • Integrated oxygenation membranes
  • Fully compatible connections with known medical devices
  • Transportability
  • Processing costs
  • Designed and manufactured according to the ISO9001 certified quality system

USEFULNESS

  • Lean cells management process
  • Increase cell yields/surface ratios
  • Overall volume reduction
  • Optimal growth condition in a close environment
  • Compatibility and adaptability to standard procedures
  • Effective deliverability due to the close system and the limited size
  • Culture medium reduction and saving on handling time

BENEFITS

  • Enhancing safety
  • Decreasing culture surface expansion and CO2 incubators number
  • High cellular products recovery, even at high cell density
  • From conventional /static to dynamic culturing methods
  • Direct transferring from laboratory to patient site
  • Lowering production costs
  • Facilitating product introduction into clinical applications by compliance to regulatory frameworks
  • Ready to automatization

DIAGNOSTIC

DRUG TESTINGON CELLSlogo_vitvo_registrato

STANDARD

EX-VIVOCELL EXPANSION

BIO-RESORBALE

REGENERATIVEMEDICINEAPPLICATION

The DIAGNOSTIC platform is focused to host and amplify cancer cells or primary human cells for ADME and cytotoxicity testing. VITVO(R) has been developed for early preclinical prediction of drug efficacy and toxicity in term of enhanced reliability VS animal model and in term of prediction improvement VS 2D miniaturized system.

The STANDARD platform was designed for ex-vivo cell amplification targeting the needs of academic laboratories and pharmaceutical cell factories (cGMP) to improve stem cell production.

The technology is suitable to host BIO-RESORBABLE scaffold to create in vitro an engineered cell-construct for tissue regeneration and repair.

New therapeutic approaches

The development of new therapeutic approaches based on manipulated cells represents the new frontier for the treatment of tumours,on the side of conventional pharmacological therapies. RR001 is a cell based product for the treatment of solid tumours, for which therapies such as chemotherapy and radiotherapy did not have a significant effect on patients’ health. The product has been classified by European Medicines Agency (EMA) as gene therapy.

RR001 technology is based on a genetically modified autologous cellular product. Human adipose perivascular stromal cells are isolated from patients’ adipose tissue through a minimally invasive liposuction procedure.

  • These cells are then cultured and expanded ex vivo, and genetically engineered.
  • The therapeutic gene inserted within the stromal progenitors induces the constant release of an antitumoural protein, which is able to kill tumour cells.
  • The cells containing the therapeutic gene are then administered to the patient as an antitumoral treatment.
  • The method for the development of the treatment agent is proprietary.

RR001

RR001 is the evolution of a project developed in the research Laboratory of Cell Therapies of the University of Modena and Reggio Emilia. The scale up of the product RR001 will take place within the GMP facility of Rigenerand, which has started the process of qualification and validation necessary to obtain the certification from Agenzia Italiana del Farmaco (AIFA).

The facility, which is 450 m2, is composed by 3 class-B rooms , 2 PLC-3B rooms, and a non classified laboratory where the quality control tests take place. Non classified research laboratories support logistically the R&D team which conduct the pre-clinical studies, necessary for the regulatory pathway of RR001.