OrganaBio to Expand Its cGMP Cell and Gene Therapy Manufacturing Facility: 19,000 Sq. Ft. Slated to Commence Operations In Q3 2021

November 20, 2020

OrganaBio has begun construction on its current Good Manufacturing Practices (cGMP) manufacturing facility for cell and gene therapy manufacturing.

A Miami-based cGMP facility, will include process development space, ISO 7 cleanrooms, state-of-the-art scientific equipment, analytics and QC laboratories, and a suite of support services to enable OrganaBio and its partners to rapidly and economically self-manufacture clinical materials.

“OrganaBio’s mission is to supply cell and gene therapy companies with mission-critical, but hard to procure resources that are needed to advance therapeutic programs,” Justin Irizarry, CEO of OrganaBio, said in a statement. “We are addressing broad supply chain challenges through an innovative portfolio of products and services that offer both preclinical and cGMP solutions for our customers.” Without clinical-grade starting materials and an accessible manufacturing solution, therapeutic developers cannot advance their program into a clinical phase.”

The company has partnered with Flad Architects and DPR Construction, leading Life Sciences architecture and construction firms, respectively, to design and build the facility, housed in a brand-new commercial business park, just 10 miles north of the Miami International Airport.

“We are excited about OrganaBio’s cGMP 19,000 square foot manufacturing facility which is set to create a large amount of lab space in the County that, in turn, will continue to grow Miami’s life sciences ecosystem,” said Michael A. Finney, President & CEO, the Miami-Dade Beacon Council. “Miami is already home to several universities actively participating in biomedical research, and OrganaBio’s new cGMP lab space will foster continued academic and commercial innovation.”

OrganaBio’s manufacturing solution will offer ready access to its portfolio of birth tissue- and adult tissue-derived cellular starting materials and expertise in cGMP manufacturing, Quality Assurance, Quality Control, and Regulatory Affairs to its customers and partners.

These resources will accelerate each therapeutics developer’s path to clinical translation and commercialization. Phase I of the cGMP manufacturing facility is slated to open Q3 2021 and will include process development space, 1-2 ISO7 cleanrooms, a QC laboratory and support spaces. The OrganaBio portfolio of cGMP cell products is subsequently slated to launch in Q4 2021.

Hot this week

Cartessa Aesthetics Partners with Classys to Bring EVERESSE to the U.S. Market

Classys, which is listed on the KOSDAQ, is one of South Korea's most distinguished aesthetic technology manufacturers, with devices distributed in 80+ markets globally. This partnership marks Classys's official entry into the American marketplace, with Cartessa Aesthetics as the exclusive distributor for EVERESSE, launched under the Volnewmer brand in current global markets.

Stryker Launches Next-Generation of SurgiCount+

Now integrated with Stryker's Triton technology, SurgiCount+ addresses two key challenges: retained surgical sponges and blood loss assessment. Integrating these previously separate digital solutions provides the added benefit of a more efficient, streamlined workflow for hospitals notes Stryker.

Nevro Receives CE Mark In Europe for It’s HFX iQ™ Spinal Cord Stimulation System

Nevro notes HFX iQ is the first and only SCS system with artificial intelligence (AI) technology that combines high-frequency (10 kHz) therapy built on landmark evidence that uses ongoing cloud data insights to deliver personalized pain relief

Recor Medical Reports: CMS Grants Distinct TPT Device Code and Category to Recor Medical for Ultrasound Renal Denervation

The approval of TPT offers incremental reimbursement payments for outpatient procedures performed with ultrasound renal denervation for Medicare fee-for-service beneficiaries. It becomes effective January 1, 2025, and is expected to remain effective for up to three years notes Recor Medical.

Jupiter Endovascular Reports | 1st U.S. Patient Treated with Jupiter Shape-shifting Thrombectomy Device

“Navigation challenges during endovascular procedures are often underappreciated and have led to under-adoption of life-saving procedures, such as pulmonary embolectomy. We have purpose-built our Endoportal Control technology to solve these issues and make important endovascular procedures accessible to more clinicians and their patients who can benefit from them,” said Carl J. St. Bernard, Jupiter Endovascular CEO. “This first case in the U.S. could not have gone better, and appears to validate the safety and performance we are seeing in our currently-enrolling European SPIRARE I study.”