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OcyonBio Client Biosimilar Solutions, Inc. Initiates Registrational Clinical Trial for Its First Biosimilar Product
Biosimilar Solutions, Inc. expects to complete the clinical study in 2022
Wednesday, March 23, 2022
AGUADILLA, Puerto Rico, March 23, 2022 (GLOBE NEWSWIRE) -- Biosimilar Solutions, Inc. announces it has started its registrational clinical trials for BSC1020®, a recombinant filgrastim product tested for biosimilarity with its reference product, Neupogen®. The design of the clinical trials was reviewed and approved by FDA and is planned to be completed in July 2022.
Neupogen® (filgrastim) is a drug that has been used successfully for cancer patients to stimulate the growth of the white blood cells, making patients less vulnerable to infections, it is expected to help patients who have bone marrow damage from very high doses of radiation in much the same way. Intensive chemotherapy in cancer patients can cause neutropenic fever and infection, which delays chemotherapy cycles and increases mortality and morbidity of chemotherapy-treated patients. Neupogen® is the first commercial pharmaceutical analog of G-CSF from Amgen Inc. and is manufactured at Amgen's Biologics facility in Puerto Rico. It has been a great success since its first approval in 1998 and is still among the top 15 best-selling drugs of 2022
OcyonBio Announces Biosimilar Solutions to Begin GMP Manufacturing in Puerto Rico
Monday, March 14, 2022
AGUADILLA, Puerto Rico, (Newswire.com) - OcyonBio announces manufacturing and operations agreement to develop biosimilar drug product facilities for Biosimilar Solutions, Inc. OcyonBio is creating an advanced therapy contract development, manufacturing organization (CDMO) that provides pre-clinical through commercial manufacturing including process development, plasmid DNA, viral vectors, cell banking, cell processing, and supporting testing capabilities.
"With our partnership development manufacturing organization model, OcyonBio is the perfect partner to usher in these biosimilars to the U.S. Biosimilar Solutions, Inc. will have streamlined control over cGMP production in a facility that has been designed to meet global regulatory expectations and readiness for FDA, EMA, and global regulatory audits," said Robert Salcedo, CEO of OcyonBio.
Cytovia driving CAR NK manufacturing to Puerto Rico
Monday, March 22, 2021
Cytovia Therapeutics will set up a facility in Aguadilla, Puerto Rico to support production of its off-the-shelf iPSC-derived CAR NK therapeutics.
Cell therapy developer Cytovia has signed a long-term joint collaboration manufacturing and operations agreement with BioSciencesCorp to integrate Cytovia’s manufacturing processes within an existing 95,000 square-foot facility.
The plant, which will include more than 40,000 square feet of cleanroom and biomanufacturing space, will be located in Aguadilla, Puerto Rico, and the firm says it will recruit manufacturing personnel beginning in summer 2021.
“The new facility gives Cytovia streamlined control over cGMP production in a facility that has been designed to meet global regulatory expectations and readiness for FDA, EMA, and global regulatory audits,” said Robert Salcedo, president of BioSciencesCorp and acting head of Cytovia manufacturing.
Biosimilar Solutions Inc. To Establish operations in Puerto Rico
Thursday, March 18, 2021
Following a $200 million investment and the creation of 328 jobs, the manufacturing company Biosimilar Solutions Inc. (Biosimilar) will be established in Aguadilla, as reported by Invest Puerto Rico (InvestPR), the public-private partnership responsible for promoting investment and economic development on the island.
Biosimilar Solutions Inc. will establish its operation at a facility of the Puerto Rico Industrial Development Company (PRIDCO). Through a $200 million investment in machinery and equipment to ensure a state-of-the-art biotechnology facility, the company will develop its novel therapies starting in 2023. He hopes to hire 328 regular jobs with a payroll estimated at $37.2 million.
The company will leverage access to skilled talent, government incentives and other assets to establish world-class facilities dedicated to the research, development and manufacture of biosimilar therapies, including a covid-19 vaccine, new cells and gene therapy, biological products, research and development to support clinical studies, among others. Through its operations, Biosimilar strengthens Puerto Rico's role as a global center for pharmaceutical innovation, manufacturing and distribution.
"Puerto Rico continues to take firm steps on its path to economic transformation. According to our strategic plan, we continue to build on the Island's legacy in the biosciences sector, attracting the best manufacturers who are innovating on a large scale. Our investment value proposition in this area supports the activities of companies such as Biosimilar, en enabled with our human capital, infrastructure and favorable business climate," said Rodrick Miller, CEO of Invest Puerto Rico.
For his part, Robert Salcedo, co-founder and CEO of BioSimilar Solutions said, "We are excited to start working in Puerto Rico, which supports our mission to make biological products affordable, accessible and with uncompromising quality. There is no doubt about the island's capabilities in the bioscience sector and we hope to do great things to help save lives. All stakeholders in Puerto Rico who helped make our presence possible here have supported us, reflecting the island's commitment to performing at the highest level in terms of life science manufacturing and commercial development."
Julio Roldan, mayor of Aguadilla, also celebrates the arrival of the manufacturer. "We received with great enthusiasm and spirit of collaboration the announcement of Biosimilar Solutions and its arrival in the municipality of Aguadilla. Our commitment to the economic development of the city is a priority. The activities of this company will give an economic injection to Aguadilla, while generating employment opportunities during the construction phase and permanent once the operations have started. This company is an added value for our people, as they will be developing therapies and medicines related to covvid-19 and its eradication, which is another of our priorities in the municipality, with the formation of our Medical Working Group, who will develop public health strategies in our municipal administration",
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Manufacturer will create 350 jobs in Aguadilla
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