Tuesday, December 06, 2022
Celularity Inc., a clinical-stage biotechnology company developing placental-derived allogenic cell therapies and biomaterial products, today announced that it received Halal Certification of its business models, commercial stage biomaterial products, and clinical and investigational stage cellular therapeutic programs, indicating that they have undergone rigorous assessment to determine that they are permissible or acceptable in accordance with Islamic law or Sharia. The certificates were issued under the authority of Circle H International, Inc. (“Circle H”) and offer the Company the ability to serve Islamic markets globally. This announcement supports Celularity’s global expansion strategy, which will ultimately include a presence in the Middle East North Africa (MENA) region and a priority focus on Saudi Arabia.
Celularity’s CEO, Chairman and Founder, Robert J. Hariri, M.D., Ph.D., said, “Obtaining broadly inclusive Halal Certification is a critical first step and an important milestone in Celularity’s plan to expand potential markets for our innovative cellular therapeutic candidates and biomaterial products. With the global Muslim population representing 28.26% of the world's population, according to Fortune Business Insights, this certification facilitates our ability to grow and expand in international markets.”
Circle H issued the Halal Certifications based on the global standards promulgated by its esteemed Circle H Sharia Advisory Council (the Council). Circle H and the Council are recognized and supported by prominent governmental and non-governmental organizations and Islamic universities. Religious leaders drawn from these prominent institutions sit on or advise Circle H and the Council, for development and support of its Halal standards.
“Celularity’s inaugural annual Halal Certification means its cellular therapy candidates and biomaterials products identified in its Halal Certifications issued by Circle H have been assessed and determined by the Council to be a permissible use under Islamic law of the post-partum placenta obtained from informed consent donors as an ethical source of cells and other biomaterials,” said CEO of Circle H, Elsayed Zayan. “Further, Celularity’s business model has been assessed and found to be organized in a manner consistent with and subject to ongoing Halal standards.”
Halal Certifications are an important prerequisite in the international markets for healthcare, and pharmaceutical products and services. According to Fitch Solutions, the MENA healthcare market is forecast to reach $261.1 billion in 2023 and grow at a compound annual growth rate of 13.6%; growth is anticipated across the aesthetics, facial rejuvenation and cell therapy categories. Other Islamic countries including Malaysia, Indonesia, and Pakistan also have large, rapidly growing Halal healthcare markets.
Celularity believes it is the first cellular therapeutics and biomaterials company to receive Halal Certification for its products, services and business models, under globally recognized Circle H standards. Celularity’s Halal Certifications cover the following:
Celularity Business Model, including its manufacturing, research & development, therapeutic, and training programs.
Celularity Biomaterial Products:
Biovance®, a decellularized, dehydrated human amniotic membrane derived from the placenta of a healthy, full-term pregnancy. Biovance® is an intact, extracellular matrix structure that provides a natural scaffold to support the body’s wound healing process.
Biovance 3L and Biovance 3L Ocular, tri-layer human amniotic membrane products focused on the surgical and ocular markets and available in both sheet and disk form.
Interfyl®, a human connective tissue matrix derived from the placenta of a healthy, full-term pregnancy. It is used by a variety of medical specialists to replace or supplement damaged or inadequate integumental tissue resulting from wounds, trauma, or surgery.
CentaFlex™, a decellularized human placental matrix derived from the umbilical cord that can be used as a surgical covering, wrap or barrier to protect and support the repair of damaged tissue.
Celularity Cellular Therapeutic Product Candidates:
CYNK: Cyropreserved placental-derived unmodified natural killer (NK) cells and genetically modified versions of placental-derived NK cells
CYCART: Placental-derived T cells engineered with a chimeric antigen receptor (CAR-T)
APPL: Placenta-derived mesenchymal-like adherent stromal cells
PEXO: Placental-derived exosomes
Celularity Biobanking Business Model (Lifebank), including placental and cord blood stem cell and placental tissue banking.
Celularity intends to establish an operating presence in the MENA region in the near future with a priority focus on Saudi Arabia. The Company will initially focus on developing opportunities for commercial-stage placental-derived biomaterial products, which are used today various indications, as well as investigational cellular therapeutics utilizing placental stem cells and placental stem cell-derived NK cells and CAR-T cells, all of which are now Halal certified. Celularity also sees a significant opportunity to establish its biobanking business in the MENA market to serve families who wish to save a newborn’s placental and cord blood stem cells and tissue for potential future use, and to establish donor stem cell banks that can be rapidly accessed and deployed in the case of public health emergencies and for other medical indications.