AlgaEnergy | January 14, 2021
AlgaEnergy N.A. Inc., the U.S. subsidiary of Spain-based AlgaEnergy S.A. furthermore, a worldwide pioneer in microalgae biotechnology, has marked worldwide item conveyance and item improvement concurrences with Laboratoire M2 Inc., a Quebec-based biotechnology organization that creates normal and practical disinfectant items, including THYMOX CONTROL® fungicide and bactericide.
AlgaEnergy formulates and creates incredible, manageable, microalgae-based yield contributions for the world's producers. Laboratoire M2's THYMOX® items, gotten from the antimicrobial intensity of thyme oil and other regular oils, are utilized in harvest and indoor farming, just as in turf and nursery markets.
Under the arrangements, AlgaEnergy will acquire restrictive worldwide rights to disperse the THYMOX crop insurance product offering through AlgaEnergy's specialty units in key rural business sectors in Europe, the Americas, Africa and Asia-Pacific. The two organizations likewise marked a permit and collective item advancement understanding under which their logical groups will together attempt to make new, value-added biocontrol products.
Avantor | June 24, 2022
Avantor, Inc. (NYSE: AVTR), a leading global provider of mission-critical products and services to customers in the life sciences, advanced technologies and applied materials industries has entered into an agreement with GeminiBio to deliver custom hydrated solutions and cell culture media to the biopharma industry.
Custom hydrated solutions and cell culture media are critical components of the bioproduction workflow, especially for emerging modalities such as gene therapy. This collaboration will complement Avantor's proven ability to serve manufacturing platforms with GeminiBio's small-to-medium scale offering, enabling customers to utilize custom cGMP products through the full development lifecycle – including early-stage research, scale-up and commercialization.
This new capability along with Avantor's recent acquisitions and site investments, support a growing portfolio of proprietary offerings, demonstrating Avantor's commitment to supporting customer workflows in both upstream and downstream processing for the biopharma industry.
With the imperative to meet patient needs quickly, our customers require custom solutions to accelerate their bioproduction goals, Customized media is critical in optimizing cell line productivity, and hydrated solutions offer efficiency to biomanufacturers as they optimize their downstream processes. Our collaboration with GeminiBio will drive increases in product yields, helping bring efficiency and speed to our customers as they scale. Together, we can drive science forward to bring therapies to the patients who need them most."
Dr. Ger Brophy, Executive Vice President, Biopharma Production for Avantor.
Enabling customers to optimize their upstream and downstream liquid manufacturing workflows by offering custom solutions, built around a strong quality foundation, has been an essential part of GeminiBio's success. Collaborating with Avantor, who shares our focus on quality, will allow us to expand our ability to address customer needs for both small and large volume process liquids."
Brian Parker, CEO of GeminiBio.
Avantor®, a Fortune 500 company, is a leading global provider of mission-critical products and services to customers in the biopharma, healthcare, education & government, and advanced technologies & applied materials industries. Our portfolio is used in virtually every stage of the most important research, development and production activities in the industries we serve. Our global footprint enables us to serve more than 225,000 customer locations and gives us extensive access to research laboratories and scientists in more than 180 countries. We set science in motion to create a better world.
Pfizer, BioNTech | May 10, 2021
Pfizer Inc. and BioNTech SE confirmed today the filing of a Biologics License Application (BLA) with the US Food and Drug Administration (FDA) for approval of their mRNA vaccine to prevent COVID-19 in people aged 16 and above. Companies will send data to help the BLA to the FDA on a rolling basis in the coming weeks, along with a proposal for Priority Review. If the BLA has been completed and duly approved for review by the FDA, the FDA will set a target date for a determination under the Prescription Drug User Fee Act (PDUFA).
The Pfizer-BioNTech COVID-19 Vaccine is now available in the United States under an Emergency Use Authorization (EUA) issued by the Food and Drug Administration (FDA) on December 11, 2020. Since then, the firms have distributed more than 170 million doses of the vaccine in the United States. The next step in the comprehensive FDA evaluation process is the submission of a BLA, which includes longer-term follow-up data for acceptance and approval.
Pfizer and BioNTech started the BLA process by providing the nonclinical and clinical data needed to justify the licensure of the COVID-19 vaccine for use in people aged 16 and up. This covers the most recent analyses from the pivotal Phase 3 clinical trial, in which the vaccine's effectiveness and safety profile were detected up to six months after the second dose. In the coming weeks, the companies will submit the required manufacturing and facility details for licensure, completing the BLA.
Pfizer and BioNTech have since submitted to expand the new EUA for their COVID-19 vaccine to cover individuals aged 12 to 15. The firms plan to send a supplemental BLA to facilitate vaccine licensure in this age group until the requisite data is available six months after the second vaccine dose.
BioNTech and Pfizer collaborated to create the Pfizer-BioNTech COVID-19 Vaccine, which is built on BioNTech's patented mRNA technology. BioNTech is the European Union's Marketing License Holder, as well as the holder of emergency use authorizations or similar in the United States (along with Pfizer), the United Kingdom, Canada, and other countries in advance of a planned application for full marketing authorizations in these countries.
The Pfizer-BioNTech COVID-19 Vaccine has not been authorized or licensed by the United States Food and Drug Administration (FDA), but it has been authorized for emergency use by the FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in people aged 16 and up. The emergency use of this product is only permitted for the duration of the declaration the circumstances justify the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act until the declaration is terminated or the authorization is revoked sooner.
At Pfizer, they utilize science and its global resources to deliver treatments to patients that significantly extend and change their lives. In the discovery, development, and manufacture of health care products, including innovative medicines and vaccines, they aim to set the benchmark for consistency, safety, and value. Every day, Pfizer colleagues collaborate in developing and emerging markets to advance wellness, prevention, treatments, and remedies for today's most feared diseases. As one of the world's leading innovative biopharmaceutical firms, they partner with health care providers, governments, and local communities to promote and improve access to reliable and affordable health care around the world.
Biopharmaceutical New Technologies is a next-generation immunotherapy firm that is developing novel cancer and other severe disease therapies. For the accelerated production of new biopharmaceuticals, the company makes use of a diverse set of computational discovery and therapeutic drug platforms. Its oncology product candidates include individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies, and small molecules from Fosun Pharma and Pfizer.