J&J in on manufacturing restart at Emergent plant behind 15M discarded COVID-19 doses
With production on pause and millions of COVID-19 vaccine doses in limbo, Johnson & Johnson has been hustling to right the ship at CDMO Emergent BioSolutions' troubled Baltimore manufacturing facility. Now, it looks as if relief is in sight.
In a matter of days, Johnson & Johnson and the U.S. FDA expect to announce that contamination problems at Emergent's Baltimore plant have been cleared up, paving the way for a manufacturing restart and a potential release of millions of Emergent-made vaccine doses.
The plant’s emergency nod to produce pandemic shots could come as early as next week, The Wall Street Journal first reported. Emergent has cranked out drug substance for more than 100 million J&J doses, CEO Robert Kramer said at a virtual congressional hearing last week.
Meanwhile, AstraZeneca is running tests to clear its own cache of vaccines made at the Baltimore facility.
Emergent declined to comment on this latest development, while Johnson & Johnson told Fierce Pharma it continues to work with the CDMO “toward securing as quickly as possible Emergency Use Authorization in the U.S. for COVID-19 vaccine drug substance manufactured at Emergent Bayview.”
The company added that it’s working “around the clock” to “develop and activate” manufacturing for its vaccine on a global scale.
Now, J&J and the U.S. have tentatively agreed to clear around 60 million Emergent-made doses of vaccine substance, which would be used either in-country or overseas, the WSJ said. Those doses aren’t yet finished, and it could be months before they’re ready to roll out, U.S. officials told the outlet.
AstraZeneca, which is looking for a new production partner after the Biden administration put J&J in charge of production at Emergent’s Baltimore plant, is testing around 60 million doses of its shot made there. Those doses could be included in a separate FDA agreement or folded into the regulator’s current plan for the 60 million J&J doses, WSJ said.
All in all, Johnson & Johnson has had a pretty good end to the week. Alongside news of the potential production restart, its single-dose COVID-19 vaccine was cleared for use in the U.K. and Mexico. While J&J’s vaccine entered the scene behind those from Pfizer and Moderna in the U.S., the company has emphasized that its one-and-done; temp-stable shot still has a role to play in the global fight against COVID-19.
On that front, the company earlier this week inked an advanced purchase agreement with Gavi, the Vaccine Alliance, to supply 200 million doses to COVAX, which aims to equitably distribute COVID-19 vaccines to lower- and middle-income countries. Johnson & Johnson could potentially sell another 300 million doses to Gavi in 2022 based on the needs of participating COVAX countries.
< Source: Fierce pharma >
READ MORE
FAT in GMP: AN IMPORTANT STAGE IN THE INVESTMENT PROJECT TO DEVELOP A PHARMACEUTICAL FACTORY
The wet granulation process in two separate steps is mostly recommended and suitable for conventional equipment like the High-speed Mixer & Granulator, Fluid-bed Dryer & Granulator…
This single-step granulation process provides effervescent granules directly by granulating the acid and the alkaline materials together. It is possible to use only water as the granulating liquid, thus controlling the effervescent reaction to granulate, or using a nonreactive liquid, like absolute ethanol or isopropanol, but in this case, it is necessary to use a binder to get the agglomeration of the particles of the raw material. There are two type of equipment complying with this technology.
This dosage form is easier to administer, particularly helpful to patients, like children, who are not able to swallow capsules or tablets. However, the manufaturing of them is more complex than conventional forms, especially in selecting technology and processing equipment
The Covid-19 pandemic has posed many new challenges for pharmaceutical startups. What needs to be done to be able to survive and develop, especially during this period. The StartUs Insight newspaper based on the analytical research of "1745 famous startups in the pharmaceutical industry in 2020", found the most outstanding startups. To be able to turn challenges into opportunities, pharmaceutical companies have a "secret" for startups to survive the pandemic.
In a attempt to provide readers with the updated news on current Vietnam pharmaceutical industry and world pharmaceutical industry trends, as well as spread the latest features of global pharmaceutical industry and Tien Tuan’s products.
Inspecting tooling and press components for wear or defects could be the most important step in improving tablet quality. There are certain inspection points that are easy to overlook yet can cause significant tablet quality issues and limit tool life. Spend a little time checking the following items for wear or defects to quickly increase tablet quality and reduce tooling cost
The pharmaceutical industry follows the most stringent requirements for manufacturing processes and used equipment also must comply with good manufacturing practices (GMP). As drug development trends change, so do manufacturing processes, much of which can now be automated...
The COVID-19 health crisis has brought strong scientific impacts and advances, while also valuable lessons for businesses, organizations and countries around the world:
At the Poison Control Center, Bach Mai Hospital has received many cases of poisoning due to the abuse of drug paracetamol to treat COVID-19. Therefore, people should be careful about medicines spread of unknown origin on social networks, before using any medicine that requires a doctor's opinion, not to use it on their own.
AUGUST BULLETINPHARMACEUTICALS NEWSLETTER
From August 1, 2021, businesses can look up the status of certificate of origin form D on the internet. At the same time, enterprises that import consignments of drugs and medicinal ingredients imported from Red Luong must present the original power of attorney, circulation permit and product testing sheet...
Maintaining production, delivery on time and keeping commitments to clients is a remarkable effort, demonstrating Tien Tuan's prestige, internal strength and high competitiveness.
According to the Vietnamese Embassy in India, this is a suggestion made by the big players in the Indian pharmaceutical industry during a trade and investment promotion meeting chaired by Vietnamese Ambassador to India - Mr. Pham Sanh Chau.
With the union of Tien Tuan company and the timely leadership of the manager board, the shipment has been successfully exported to customers in the Asian.
On the purpose of providing to valued clients & readers the latest Vietnamese pharmaceutical news and international pharma production trends, update state-of-the-art features, global technology, we periodically send to you the monthly bulletin.
What do the terms 'containment' and 'isolation' mean in the pharmaceutical industry? Why must all cancer drug production line adopt this system?
Common vocabularies and definition in Pharmaceutical Validation.
This pilot batch of Sputnik V vaccine brings hope to Vietnam's community vaccination campaign.
Before 2020, the concept of Ultra Low Temperature Freezers (ULT) was very little known, except in the medical and related industries. But when Pfizer announced that their vaccines required storage at -70°C, a world reeling from the pandemic took a big interest in the concept of "deep cryo" preservation.
Hand sanitizers are over-the-counter (OTC) drug products. Symptoms of headache, nausea, and dizziness may occur after applying alcohol-based hand sanitizer to the skin. These symptoms can be caused by inhaling vapors from hand sanitizer, by exposure to confined spaces or places with poor air circulation...The US Food and Drug Administration (FDA) has just released a warning about washing hand in this Pandemic.
In a attempt to provide readers with the updated news on current Vietnam pharmaceutical industry and world pharmaceutical industry trends, as well as spread the latest features of global pharmaceutical industry and Tien Tuan’s products.
According to WHO estimates, nearly $40 billion is lost each year to counterfeit products. Not only economic losses, counterfeit drugs also increase health risks, lead to drug recalls, and tarnish the brand image of the struggling pharmaceutical industry.
One of the measures the industry took to overcome this challenge was to implement pharmaceutical serialization to protect the consumers.
Coating becomes an essential technology in pharmaceutical. During last 25 years, the coating layer has obviously undergone some changes. More improvement in coating technologies have been made to enhance higher quality of drug and its manufacturing operation.
There is idea supposed that the traditional pharmaceutical industry is quite conservative and so a multitude of reasons ranging from regulation to financial resources can be given to reason for the delay in the adoption of new technologies. However, we will certainly witness dramatic and innovative changes in the pharmaceutical industry in the coming years as Industry 4.0 is becoming a global technological revolution.
The European Commission has approved the lung cancer drug as an add-on treatment for adults diagnosed early enough for the tumour to be surgically removed, and who have a mutation of the EGFR gene.
Vietnamese pharmaceutical companies are gradually being outdone by foreign competitors. With a series of loosening policies published, Vietnam's pharmaceutical market is a lucrative piece of cake for foreign pharmaceutical companies to jump in.
The pharmaceutical Industry is sensitive to Covid-19 but is slowly recovering. The Covid-19 pandemic is a great challenge for the entire population and manufacturing industries, especially the pharmaceutical industry, in case of strong community spread. However, at the present, the health care target is the main goal and an essential expenditure for the people. Demand for Medicines will only be temporarily delayed in the short term and will gradually recover.
(According to Vietnamreport) Top 10 prestigious pharmaceutical companies are ranked based on scientific and objective principles. Companies are evaluated and ranked based on 3 main criteria: (1) Financial capacity shown in the latest year's financial statements; (2) Media reputation is assessed by Media Coding method - encoding articles about the company on influential media channels; (3) Survey of stakeholders was carried out in October and November 2020.
The COVID-19 pandemic occured in the end of 2019 and officially broke out in early 2020, leading to many complicated consequences, directly affecting public health and the world economy.
It seemed that the pharmaceutical industry would be the main development industry during the Covid pandemic, but on the contrary, the Pharmaceutical industry as well as other industries have suffered a lot of damage from Covid.
The Seminar “How to build pharmaceutical factory complying to EU-GMP?” held by Tien Tuan on August 18th 2017 at Meeting Room No. 2 – Saigon Exhibition and Convention Center , Ho Chi Minh City was a successful event and the topic gathered much attention from industrial specialists and experts from Vietnam pharmaceutical industry.
In order to assist pharmaceutical companies in Vietnam to catch up with the latest development in processing technology, Tien Tuan would like to invite you to come and discuss with us at seminars 1) Telstar – Isolator and 2) Natoli with complete solution for puch, die and tableting. The seminars will be organized at Ha Noi International Exhibition Center – 91 Tran Hung Dao st., Hoan Kiem District, Ha Noi
