Elliot Medical Solutions Provide Professional Consulting Services for Chinese Pharmaceutical Industries and Biotechnology Companies Developing Cellular & Gene Therapy

Simply speaking, cellular therapy is therapeutic treatment using functional cells in replacement of damaged cells. When some cells lose function or exhibit impaired mistakes, scientists can manufacture functional cells and put them to where they are needed. For example, Type 1 diabetic patients’ islet cells (cell capable of synthesizing insulin) cannot work properly so that the patients need to be injected with insulin. Scientists can isolate functional islet cells from proper donor, and then inject these functional islet cells to diabetic patients to synthesize insulin. This is a kind of cellular therapy which can avoid patients from multiple injection of insulin. Gene therapy is similar to cellular therapy but it uses gene as therapeutic treatment, not cells. Scientists inject genetic drugs into patients to treat specific disease. Since genetic drugs need to be administrated intravenously, how to target genetic drugs to specific tissues or organs remains to be investigated. Advanced cellular and gene therapy is combination of the above two therapies. Human cells lack of certain protein or enzyme cannot function properly. If a specific gene can repair function of the cells, transfer of specific gene drug into the cells will result in the synthesis of protein of enzyme and make cells work again. Scientists can use virus or non-viral carrier to deliver genetic drugs into cells to produce functional cells. Adoptive transfer of the genetic-engineered functional cells to patients can result in therapeutic efficacy. Such therapy is cell-based gene therapy.

Our experienced, multidiscipline team offer a high-integrity approach to the most daunting challenges for medical device manufacture and cellular therapy developers. Our team of Advanced Cellular & Gene Therapy has expertise in regulatory affairs, IND/IDE applications, GMP/GTP manufacturing, cellular and gene product testing, as well as process analysis and optimization. We provide highly reliable project solutions for pharmaceutical industries or biotechnology companies to translate the cellular and gene therapeutic products from “bench” to “bedside”.

We provide professional services:

Guidance for development of cellular and gene therapeutic products

--- Materials and technology

--- Process analysis, optimization

--- Maximize cell yield, function

--- High-throughput closed-systems

--- Enable process automation

--- Product, process specification

--- Investigator and clinical site selection

GMP/GTP Manufacturing

--- Facility design

--- Environment control

--- Equipment selection, qualification

--- Process and analytical method qualification, validation

--- Laboratory operations

--- Personnel training

Regulatory Compliance

--- Requirements, applicability, strategy

--- FDA-CBER OCTGT, CDRH, AABB, AATB, FACT, NIH-RAC

--- Pre-IND, IND, IDE applications, amendments

--- Audits and gap analysis

--- QA system design

Specialized Projects

--- IND/IDE applications, amendments

--- Cell collection, storage, banking

--- GMP /GTP cell engineering: cell selection, ex vivo cell expansion, activation, and transduction.

--- Product testing: phenotype, viability, function, sterility.

Stem Cell-based Therapy:

--- Bone marrow, blood, umbilical cord blood stem and progenitor cells

--- Mesenchymal stem cells

--- Multipotent adult stem cells

--- Immunotherapy, tumor vaccines

--- Dendritic cells, NK cells, lymphocytes

Gene Therapy

--- Stem cells, lymphocytes

Tissue-specific Cell Therapy

--- Islet cells, hepatocytes, neural cells, chondrocytes, dermal cells