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ESENCHY THERAPEUTICS
STEM CELLS CLINICAL CONSULTING
STEM CELLS
What are stem cells?
A stem cell is essentially a “blank” cell that is capable of becoming a differentiated cell in the body, such as a nerve cell, a muscle cell, any organ cell or any other type of cell. The primary roles of stem cells in a living organism are to maintain and repair the tissue in which they are found. They can be used to repair or replace tissue and cells in the body whether they are damaged from injury or aging and the first body part replacements have already been done in humans.
There is a hierarchy of stem cells that starts with the most undifferentiated, totipotent, which can become anything including a human being. These can only be derived from the blastocyst stage of an embryo during the first four or five days after fertilization. The next stage of differentiation is pluripotent cells, which can develop into any tissue, organ or adult cell type. These can be derived from adult stem cell sources and this is the level of undifferentiated state that has been achieved in animal studies with iPS cells. Multipotentent progenitor cells are the next level of differentiation and have the potential to most any type of cell in the body. These cells are committed to becoming a specific type of cell.
There is now work being done with induced pluripotent stem cells (iPS) which are derived from a person’s tissue such as skin or teeth, and taken back to an undifferentiated state where they can be turned on to become other kinds of tissue. We expect to see iPS cells to be a major source of stem cells in the decades to come.
There are several general categories types of cells from the source point of view. Embryonic derived and fetal derived stem cells are the more controversial types of cells. The embryonic cells are derived from the inner cell mass of the blastocyst, an early stage embryo, which reaches this stage about four to five days after fertilization. The fetal stem cells are taken from the more developed aborted fetuses. Many believe that this is biological waste that would be thrown away and argue for using them for saving lives. Others have objections to this source and now even the Vatican supports the use of adult stem cells.
Adult stem cells derived from a person’s own body are called autologous. These come from bone marrow, fat (adipose tissue) and blood. Each source provides a different mixture of specific stem cell types.
Adult stem cells are also derived from other people and for instance the more than 50,000 stem cell transplants that are performed around the world each year are from other people. These stem cells are called allogeneic. But they also come from a very rich source—umbilical cord blood and tissue as well as the placenta and amniotic fluid from full term births. Many people mistake this for embryonic stem cells and they are absolutely not—they are adult stem cells. They are also commonly stored by freezing them, by families when a child is born. There are many advantages to using adult stem cells and even the Vatican supports their use.
COMPANY
Our team members come from companies that have been pioneers in the implementation of Quality Standards in the biotech and pharmaceutical industry. We are specialized in the development of Advanced Therapies and Innovative Medicines for the manufacturing of Gene and Cell Therapy medicines for clinical trials.
We are a client-centered company. In addition to providing our own services, we work with our clients and offer them, upon request, one-off collaboration with other companies with expertise in each of the project’s strategic areas: Engineering (for the design and set-up of facilities).
We will work with your company like your own CMO as a third-party manufacturing; working with CROs for the management of clinical trials; service companies (cleaning and maintenance of cleanrooms, etc.), etc. Because of our comprehensive services, all of our clients can focus on their main objectives, because we offer them all the resources they need.
Discovery
We have the most comprehensive drug discovery department and a multidisciplinary staff of scientists. We have the scientific excellence and technological capabilities to support our discoveries throughout the drug development life cycle, from target identification, to IND programs. Our team takes a true collaborative approach working in partnership with other third parties to find and follow the optimum path to market while moving forward together to bring novel therapies to the patients who need them.
Complex cellular assays, including RNAi cell lines and human primary cell-based assays, allow us to accelerate discovery programs by screening in biologically relevant systems. Combining proprietary adenoviral technology with complex cellular assays allows us to deliver novel, validated drug targets in multiple therapeutic areas.
SERVICES
Technical, regulatory and strategic consulting.
We provide regulatory, technical and quality assurance support as well as project feasibility studies, training, management of technology transfers, auditing services and the preparation of the necessary documentation.
Training
Ample training program and seminars in the field of Advanced Therapies, covering different aspects of regulations and development. We also provide training in the peculiarities of Manufacturing and Quality System processes.
Implementation of Good Manufacturing Practices (GMP)
We advise, cooperate and collaborate with clients who need our wholistic consulting services for the implementation, training and GMP certification of manufacturing facilities for Advanced Therapies and Innovative Medicines.
Elaboration of quality documentation
We prepare specific documentation and elaborate standardized working procedures; validation protocols adapted to your organization; processes and a Quality System that will comply with the requirements of Quality Standards.
Project feasibility studies
We collaborate with our clients in the design of their optimal regulatory path. We also make a financial assessment to determine the investment needed for the development of medicines for Advanced and Innovative Therapies.
Preparation and review of Clinical Trial application forms
We prepare and/or review the Investigational Medicinal Product Dossier (IMPD), based on the documents shared by the client as well as the Research Protocol.
Preparation of the application document for the Use Authorization
We prepare the documentation to apply for the Use Authorization for Advanced Therapy Medicinal Products (ATMPs) (quality, clinical and non-clinical documentation) of non-industrial manufacturing, in the context of hospital institutions.
Technology transfer
Our manufacturing process comes from a GMP point of view. We offer clients determine the most appropriate manufacturing process, scale-up, validation and quality control. We also elaborate the necessary documentation for each Advanced Therapy Medicinal Product (ATMP) for those clients who need to adapt their R&D products and processes to standardized GMP manufacturing or who need to transfer their manufacturing processes to another manufacturer (CMO).
Cell Therapy Products & Services
The complexities of cell therapy programs present not only scientific but technical challenges as well. They are highly customized and vary greatly based on product attributes. Due to tremendous promise to cure many types of diseases, there is significant pressure to accelerate these programs through regulatory approval faster than ever. It is therefore crucial to find a partner who offers access to a robust scientific and regulatory network and integrates the various elements of your program to achieve your milestones.
Research-use Human Cells
Fresh and cryopreserved leukopaks, mobilized leukopaks, bone marrow products, cord blood products, and isolated cells (MNCs, T cells, NK cells, and other cell populations) to support and expand your research efforts.
GMP-compliant Human Cells
Cell sourcing for superior leukopak and bone marrow aspirate cellular starting material that adheres to strict cGMP requirements for the advancement of autologous and allogeneic cell therapies.
Diseased State Biospecimens
Our cell sourcing capabilities include Covid-19 related products, isolated immune cells, tissues, and fluids collected from patients undergoing treatment for various disease types.
Specialized Products
Customizable product requests, antigens, bio/cryopreservation media, and in vivo solutions.
Customized Products and Services
Beyond cell sourcing material, we offer specialized services such as targeted donor recruitment through HemaCare Donor Center (a Charles River company) and contract research to facilitate the success of your cell therapy.
Animal Primary Cells
We offer a large selection of cryopreserved murine immune system mast cells, bone marrow cells, dendritic cells, macrophages, spleen cells, and chondrocytes to complement our human immune cell products.
OUR WORKS
1. Regulatory,
We understand the scientific and technical challenges , it’s for that we work ensuring compliance, flexibility on the production capability and on-time delivery.
A vital part of the clinical trial or marketing application, or post-approval strategy is CMC (Chemistry, Manufacturing and Control). We reach our milestone with scientific and regulatory expertise in all areas of CMC development. In order to ensure our program progresses as scheduled. During Drug Substance and Drug Product development, we follow specialized guidance and support. At ESENCHY, we understand how to anticipate and overcome potential difficulties in the development of new chemical entities and biologics, including cell and gene therapy.
2. Preclinical development,
Due to the increasing complexity of drug development and regulatory environment, the nonclinical and clinical plan, critical component, throughout the healthcare product development cycle require more and more customization and global vision. Nonclinical and clinical data are presented and interpreted in various regulatory interactions during the life cycle of a product.
At ESENCHY, our regulatory and nonclinical experts help design an optimal nonclinical development plan and prepare critical meetings with regulatory agencies adopting a benefit-risk approach to enable our products to move to the next phase.
3. Clinical Development,
- Study Design: Design and review patient-centric protocol with endpoints. Align the study with overall development goals taking into account all stakeholders.
- Study Preparation: Optimize the timeline to first-patient-in. Advice for patient recruitment and network building. Legal representation in the EU/EEA, UK and Switzerland.
- Study Submission: Prepare and submit clinical trial application to secure study approval.
- Study Conduct & Data Management & Analysis: Optimize interaction between all stakeholders and ensure data collection and quality supporting your endpoints.
- Our deep understanding and discerning power regarding the regulatory requirements and their implementation in different bodies and regions brings unique insights to our project.
- We have a global reach and the capability to manage the study long-term.
- Our therapeutic expertise, product knowledge and know-how in orphan diseases, oncology and immunology empower us for today’s complex studies.
- Clinical Safety: Build a scalable safety system, oversee and manage the clinical risk assessment.
- Regulatory Maintenance: Maintain regulatory dossier to ensure compliance.