In addition, the Company announced that
Octomera is focused on changing the paradigm of centralized cell and gene therapy (CGT) production to produce treatments in a decentralized point of care manner. Octomera provides the supply and development of decentralized services utilizing the POCare Network of POCare Centers deployed independently and in partnership with academic institutes, hospitals, and industry partners. POCare Centers within the Network are harmonized and standardized by Octomera.
“The centralized biotech manufacturing model simply does not translate to efficient or cost-effective CGT production within the clinical development stage, and even less so for approved products,” said
“Our strong process development capabilities coupled with our growing number of POCare sites enable us to decentralize the supply of cell and gene therapies. By initially developing a robust production process programmed into our proprietary, agnostic, and flexible OMPULs (
POCare centers and OMPULs are designed to standardize CGT production processes for quality and regulatory compliance with the ability to scale to full cGMP processing across the globe at a lower cost. A GMP team with significant practical experience oversees the centers and OMPULs and works to implement advanced quality management and IT solutions. Uniquely, OMPULs can be deployed and operational in 2-3 months within an existing structure or in available outdoor space, and production capacity can easily be scaled via additional units. The interior can be purpose-built to include GMP-compliant production space, with options for quality control labs and warehouse spaces.
“Metalmark is pleased to support the launch of Octomera as the company reiterates its focus on providing standardized, decentralized, cost-effective development and production of CGT products,” said
To learn more about Octomera, connect with the team at contact@octomera.com.
About
Notice Regarding Forward-Looking Statements
This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended. These forward-looking statements involve substantial uncertainties and risks and are based upon our current expectations, estimates and projections and reflect our beliefs and assumptions based upon information available to us at the date of this release. We caution readers that forward-looking statements are predictions based on our current expectations about future events. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Our actual results, performance or achievements could differ materially from those expressed or implied by the forward-looking statements as a result of a number of factors, including, but not limited to, the expected deconsolidation of Octomera from our consolidated financial statements, our reliance on, and our ability to grow, our point-of-care cell therapy platform and OMPUL business, our ability to achieve and maintain overall profitability, our ability to manage our research and development programs that are based on novel technologies, our ability to control key elements relating to the development and commercialization of therapeutic product candidates with third parties, the timing of completion of clinical trials and studies, the availability of additional data, outcomes of clinical trials of our product candidates, the potential uses and benefits of our product candidates, our ability to manage potential disruptions as a result of the COVID-19 pandemic, the sufficiency of working capital to realize our business plans and our ability to raise additional capital, the development of our POCare strategy, our trans differentiation technology as therapeutic treatment for diabetes, the technology behind our in-licensed ATMPs not functioning as expected, our ability to further our CGT development projects, either directly or through our JV partner agreements, and to fulfill our obligations under such agreements, our license agreements with other institutions, our ability to retain key employees, our competitors developing better or cheaper alternatives to our products, risks relating to legal proceedings against us and the risks and uncertainties discussed under the heading "RISK FACTORS" in Item 1A of our Annual Report on Form 10-K for the fiscal year ended
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