Monday, January 16, 2023
sterility by design
Dr. McCullough on infertility
https://www.bitchute.com/video/gG5ETBTHf3i2/
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Dr. Shoeaker on pregnancy loss, brief https://www.bitchute.com/video/t5QEtYGlloua/
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Dr. Kimberly Biss on vax damage to women, brief https://www.bitchute.com/video/vEgsE01coJHE/
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Naomi Wolf Author - 78% pregnancies killed by the Spike jab -
https://www.bitchute.com/video/t4hqNH4hzXTl/
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infertility in Africa, very detailed https://www.bitchute.com/video/bnyX1hOlJXOi/
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‘global vaccine leader’
Published Feb. 20, 2020 Updated Feb. 21, 2020 By Kristin Jensen
WuXi Vaccines on Tuesday said it’s signed a 20-year deal with an unidentified “global vaccine leader” to exclusively manufacture one of the company’s vaccine products.
The $3 billion contract calls for a dedicated facility to produce the vaccine for worldwide sale. The Chinese manufacturer is already building a plant in Ireland and expects it to be operational in 2022, according to a Feb. 18 statement.
WuXi Vaccines, a joint venture of WuXi Biologics and Shanghai Hile Bio-technology, first announced the signing of a letter of intent for the deal in May of last year.
WuXi Vaccines says the deal reflects an endorsement of its manufacturing capabilities for vaccines, which can be challenging to produce.
The company is trying to expand its footprint globally, starting with a $240 million investment in the new facility in Ireland. The plant will be part of the WuXi Biologics Campus and next to what it calls the “Factory of the Future” biologic drug substance manufacturing facility, slated to open in 2021.
WuXi Vaccines hasn’t released the name of the global vaccine manufacturer. Sanofi, one of the top four vaccine makers globally, said in May it wasn’t involved and Pfizer confirmed to BioPharma Dive on Feb. 20 that it’s not involved.
Merck & Co. declined to comment, while GlaxoSmithKline, the other vaccine major, didn’t respond to requests for comment in May and again on Feb. 20.
WuXi Biologics, meanwhile, has been working to expand its presence as a top contract producer of biologic medicines. In January, the CDMO announced a deal to buy Bayer’s drug product manufacturing facilities in Leverkusen Germany, after spate of manufacturing partnerships in 2018 and 2019.
As of last June, WuXi Biologics was contracted to work on 117 clinical projects, 15 of which are in Phase 3, and one commercial project.
Although the company has extensive operations in China, WuXi Biologics says its business has been largely unaffected by the coronavirus outbreak. The company does not operate in Wuhan — the epicenter of the virus’ spread — and doesn’t have any major suppliers in the city.
Others have seen some impact. WuXi Apptec, which originally housed WuXi Biologics, said in a Feb. 12 statement that its site in Wuhan remains closed.
https://www.biopharmadive.com/news/wuxi-vaccine-20-year-deal-global-leader/572668/
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WuXi Biologics clinches deal to build first U.S. facility at Boston area hub
By Kyle Blankenship
May 19, 2020 09:45am https://www.fiercepharma.com/manufacturing/wuxi-biologics-inks-deal-to-build-first-u-s-facility-at-manufacturing-hub
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WuXi STA Opens a New Sterile Lipid Nanoparticle Formulation Facility to Enhance Global CRDMO Services for Customers
2022/09/08
SHANGHAI, September 9, 2022 – WuXi STA, a subsidiary of WuXi AppTec, today announced the opening of a new sterile lipid nanoparticle (LNP) formulation development and manufacturing facility at its Wuxi city campus. Created in response to the increasing demand for complex injection dosage forms, this new facility marks the company’s fast-growing parenteral formulation capabilities and is yet another opportunity to enable customers as they develop and deliver better medicines for patients.
This new facility integrates multi-channel chip, micro-mixer system, and complex preparation system into a multi-channel micro-mixer core LNP manufacturing platform, offering significant advantages in drug-loading, liposome particle size control, and encapsulation efficiency. In addition, the modular design provides greater processing flexibility, enabling this platform to serve a wide range of manufacturing scales from 10-50 L per batch….
WuXi STA has 12 sites across the U.S., Europe and Asia that offer a wide range of services and meet global regulatory standards. Together with other development and manufacturing sites, this new platform provides considerable synergy with the company’s oligonucleotide CRDMO platform. The LNP delivery system is particularly advantageous in overcoming the bioavailability challenge of oligonucleotides and their conjugates.
Dr. Minzhang Chen, Co-CEO of WuXi AppTec and CEO of WuXi STA, commented, “We are pleased to support our partners with this state-of-the-art LNP facility to meet the growing demand for advanced injection dosage forms. We will continue to expand our CRDMO platform’s capacity and capabilities to enable our partners to accelerate more innovative drugs to market for patients worldwide.” https://www.wuxiapptec.com/news/wuxi-news/5194
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5-18-2020 COMIRNATY® (BNT162b2)
(modRNA) candidate encoding an optimized SARS-CoV-2 full-length spike protein antigen. COMIRNATY is the lead candidate of the Pfizer/BioNTech BNT162 program, which includes another modRNA candidate that encodes an optimized SARS-CoV-2 receptor-binding domain (RBD) antigen antigen; a uridine containing mRNA (uRNA) candidate; and a candidate using self-amplifying mRNA (saRNA). The other candidates are known as BNT162a1, BNT162b1, and BNT162c2.
Each mRNA format is combined with a lipid nanoparticle (LNP) formulation. The larger spike sequence is included in two of the candidates, while the smaller optimized receptor binding domain (RBD) from the spike protein is included in the other two candidates….
$2.05B U.S. Army Contract—The U.S. Department of Defense on January 19 announced that Pfizer had been awarded a $2,047,500,000 modification (P00007) to U.S. Army contract W58P05-21-C-0002 for an additional 300 million doses of COMIRNATY for international donation to low and low-middle income countries. The contract, awarded through U.S. Army Contracting Command, Aberdeen Proving Ground, Maryland, has an estimated completion date of Sept. 30, 2022.
The contract is being funded through Fiscal Year 2021 Coronavirus Response and Relief Supplemental Appropriations Act funds that were obligated at the time of the award. Contracting authority was 2021 Status: Supplemental BLA Filed for Ages 12-15—Pfizer and BioNTech on December 16 said they submitted a supplemental Biologics License Application (sBLA) to the FDA seeking expanded approval of COMIRNATY® (COVID-19 Vaccine, mRNA) to include individuals ages 12-15.
The sBLA included updated longer-term follow-up data from the companies pivotal Phase III clinical trial of 2,228 participants 12 through 15 years of age. In the trial, a two-dose series of the Pfizer-BioNTech COVID-19 Vaccine (30-µg per dose) was 100% effective against COVID-19, measured seven days through over four months after the second dose, according to the companies. …Pfizer and BioNTech also said they intend to file these data with the European Medicines Agency (EMA) and other regulatory authorities around the world “in the coming weeks.”…
Brazil Manufacturing Agreement—Pfizer and BioNTech said August 26 they signed a letter of intent with the Brazilian biopharma Eurofarma Laboratórios to manufacture COMIRNATY for distribution within Latin America. The value of the agreement was not disclosed. Manufacturing of finished doses will commence in 2022. At full operational capacity, the annual production is expected to exceed 100 million finished doses annually—all of which will exclusively be distributed within Latin America, the companies said.
Ugur Sahin, MD, CEO and Co-founder of BioNTech, said his company and Pfizer had delivered more than 1.3 billion doses, with plans to deliver 3 billion doses in total by the end of 2021.
Comparison vs. Natural Immunity—In a preprint posted August 25 on medRxiv, a team of Israeli researchers showed that natural immunity conferred longer lasting and stronger protection against infection, symptomatic disease and hospitalization caused by the Delta variant of SARS-CoV-2 compared to COMIRNATY.…
FDA ISSUES FULL APPROVAL—Pfizer and BioNTech on August 23 received the FDA’s first formal approval for a COVID-19 vaccine when the agency approved the companies’ Biologics License Application for BNT162b2, which according to the FDA will be marketed going forward as Comirnaty, its brand name in Europe. Comirnaty will be indicated for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine will also continue to be available under emergency use authorization (EUA), for adolescents ages 12-15 years of age, as as well as for the administration of a third booster dose in specified immunocompromised individuals….
FDA Reportedly Accelerating Review of Full Approval—The FDA’s Center for Biologics Evaluation will deprioritize some existing work in order to accelerate its review of the Pfizer/BioNTech BLA application for BNT162b2, STAT reported on July 30, citing an unnamed senior agency official who characterized the upcoming review as a “sprint.” CBER Director Peter Marks, MD, PhD, will “largely” oversee review of the application in place of Marion F. Gruber, PhD, Director of CBER’s Office of Vaccines Research and Review, according to the report….
African Union Distribution Agreement—Pfizer and BioNTech said July 21 that they signed a letter of intent with The Biovac Institute, a CapeTown, South Africa biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 vaccine for distribution within the African Union. Under the agreement, whose value was not disclosed, Biovac agreed to perform manufacturing and distribution activities within Pfizer’s and BioNTech’s global COVID-19 vaccine supply chain and manufacturing network, which expanded as a result to three continents and more than 20 manufacturing facilities. To facilitate Biovac’s involvement in the process, technical transfer, on-site development and equipment installation activities will begin immediately, Pfizer and BioNtech said.
Pfizer and BioNTech said that expect Biovac’s Cape Town facility to be incorporated into their vaccine supply chain by the end of 2021. Biovac agreed to obtain drug substance from facilities in Europe, with manufacturing of finished doses set to begin in 2022. At full operational capacity, the annual production will exceed 100 million finished doses annually. All doses will exclusively be distributed within the 55 member states that make up the African Union, the companies added. https://www.genengnews.com/covid-19-candidates/biontech-pfizer-and-fosun-pharma-bnt162/
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