STAT News

SEPTEMBER 21, 2022

Catalent, one of the largest contract manufacturers in the pharmaceutical industry, was cited by the U.S. the same plant where the company helps produce two Covid-19 vaccines. Food and Drug Administration for a series of quality control failures at a facility in Bloomington, Ind.,

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Pharma Mirror

MARCH 31, 2022

Symbiosis Pharmaceutical Services Ltd (Symbiosis), a fast-growing contract manufacturing organisation (CMO) specialising in sterile global manufacture of pharmaceuticals, vaccines and biopharmaceuticals including Advanced Therapeutical Medicinal Products (ATMPs), has announced the completion of a £1.3

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Pharmaceutical Technology

APRIL 4, 2023

Indian pharma manufacturing continues to be the backbone of drug supplies worldwide, and GlobalData analysis suggests US overreliance on the country for generic drug supply. Pharma manufacturing facilities in Andhra Pradesh and Telangana accounted for 22.5% © GlobalData. ©GlobalData.

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pharmaphorum

OCTOBER 9, 2020

The European Commission has taken its advance orders for potential COVID-19 vaccines to more than 1.1 If the vaccines are approved and the contracts are fulfilled, they would supply more than two shots apiece for each of the EU’s 446 million inhabitants. Read more: [link] pic.twitter.com/rwvJEX5oVJ.

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XTalks

NOVEMBER 11, 2021

The US National Institutes of Health (NIH) and Moderna continue to be at loggerheads in a COVID-19 vaccine patent spat, with the federal health agency not ruling out legal action against the Cambridge, Massachusetts-based biotech. Related: Moderna Unwilling to Share COVID-19 Vaccine Formula Amid Vaccine Inequities.

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Pharmaceutical Technology

AUGUST 30, 2022

SUS provides full, free and universal access to healthcare for the country's entire population (215 million), which spends around 10% of its gross domestic product (GDP) on healthcare. Only a limited number of international pharma companies, however, operate manufacturing sites in the country.

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pharmaphorum

JANUARY 7, 2021

Shortly after launching large-scale trials of its COVID-19 vaccine candidate, CureVac has the partner it will need to roll the shot out at scale if it works as hoped. The post Bayer joins the COVID-19 vaccine push, backing CureVac shot appeared first on.

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Pharmaceutical Technology

JULY 29, 2022

Pfizer (New York, New York) and Moderna’s (Cambridge, Massachusetts) Omicron-specific Covid-19 vaccines are in late-stage development, have demonstrated good efficacy against the variant and will likely be available to the public later this year to provide an additional booster and increase demand for injectable manufacturing.

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Pharmaceutical Technology

DECEMBER 15, 2022

The Singapore Government has launched Biologics Pharma Innovation Programme Singapore (BioPIPS), which aims to increase the country’s manufacturing capacity for biologics, including recombinant proteins and vaccines. The organizations plan to use data analytics to improve manufacturing processes. Additionally, Merck & Co.

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pharmaphorum

JANUARY 19, 2021

Supplies of COVID-19 vaccines are in the spotlight as countries across the world step up their immunisation campaigns against the pandemic. As vaccine manufacturers face unprecedented demand for their newly approved products, the race is on to provide enough shots for billions of people across the world.

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Pharmaceutical Technology

JULY 14, 2022

Pharmaceutical Technology looks at drugs and biologics with recent regulatory verdicts that will likely impact manufacturing volumes. In this ongoing series , we put a spotlight on contracts between pharma companies and contract manufacturing organizations (CMOs). Covid-19 vaccines stay in the spotlight.

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Roots Analysis

FEBRUARY 20, 2022

In fact, it has been observed that around 40% of the pharmaceutical products approved by regulatory organizations exhibit poor bioavailability / solubility. Role of nanoparticles has been well established across various markets, such as healthcare, paint, consumer products ( including sunscreens, cosmetics ), aerospace and glass industries.

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pharmaphorum

APRIL 6, 2021

AstraZeneca is shifting production of its COVID-19 vaccine away from a plant in Baltimore which also makes Johnson & Johnson’s shot, after human error resulted in the contamination of 15 million doses. . Emergent claims however that one batch of the vaccine simply failed quality controls, and no contamination took place.

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Pharmaceutical Technology

AUGUST 16, 2022

Even giant pharma companies with large internal production capabilities are leaning on outsourcing to meet market demand for huge numbers of injectables, including high-value biologics and Covid-19 vaccines, according to a GlobalData analysis. Why do large and mega-cap sponsors outsource?

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Pharmaceutical Technology

NOVEMBER 22, 2022

These industries unexpectedly also included biotech, which was not a particularly strong area for Chinese manufacturing, which is more recognised for generics production. Guangdong is based in the south and has a comparatively strong number of manufacturing relationships producing innovative FDA and EMA drugs.

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Roots Analysis

JANUARY 14, 2024

With the increased interest and gradual shift of investment from small molecule drugs to biologics and the establishment of several biologics manufacturing companies / biologics CMOs, more than 250 biologic therapies and vaccines have been developed, globally.

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XTalks

FEBRUARY 11, 2021

Amidst growing global shortages of COVID-19 vaccine supplies, inaugural (by way of authorizations/approvals) COVID-19 vaccine maker Pfizer is addressing the issue by working to cut the manufacturing time of its vaccine by almost half. Related: Pharma Rivals Step Up to Assist with COVID-19 Vaccine Production.

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pharmaphorum

APRIL 22, 2021

Emergent BioSolutions’ difficult month has been made worse by an FDA report into its facility in Baltimore, which has been blamed for the wastage of millions of doses of Johnson & Johnson’s COVID-19 vaccine. . AZ’s vaccine meanwhile has yet to be approved in the US. Award of federal contract probed.

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The Pharma Data

OCTOBER 22, 2021

At least 24 million doses of the mRNA-based vaccine will be filled in 2022 into vials under sterile conditions at Novartis Technical Operations state-of-the-art facility in Ljubljana, Slovenia New agreement follows earlier supply agreement for the fill and finish of more than 50 million doses in 2021 at the Novartis Stein site in Switzerland.

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Pharmaceutical Technology

DECEMBER 12, 2022

In this last 2022 edition of the series, which started in June , Pharmaceutical Technology is tracking major trial announcements and decisions by regulators and reimbursement agencies that have occurred since mid-October, as well as their potential impact on manufacturing plans. Source: GlobalData Pharmaceutical Intelligence Center.

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pharmaphorum

JULY 15, 2022

In the final piece of a three-part series, Ben Hargreaves explores how manufacturing infrastructure was rapidly built up to the required capacity to ensure sufficient supply of COVID-19 vaccines, and what still remains to be done to improve vaccine equity globally. All angles. No unqualified success.

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Roots Analysis

FEBRUARY 26, 2024

In fact, the share of biologics in the overall pharmaceutical contract manufacturing market has increased from 16% in 2006 to over 25% in 2017. Having reported over 70% increase in revenues over the past 5-6 years, the market for biologically derived products is currently estimated to be worth more than USD 200 billion.

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pharmaphorum

JULY 13, 2021

The FDA has added a new warning on the Johnson & Johnson COVID-19 vaccine, saying the shot has been linked to a serious but rare side effect – Guillain-Barré syndrome – that can cause muscle weakness. The cases have mostly been recorded two weeks after vaccination and seem to be more common in men aged 50 and older.

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Pharmaceutical Technology

JANUARY 30, 2023

This is mixed news for contract manufacturing organisations (CMOs), as large CMOs such as Thermo Fisher Scientific (Waltham, MA, US) and Catalent Inc (Somerset, NJ, US) are typically involved in the manufacture of the most innovative products. Lilly has disclosed only in-house manufacturing locations for the drug.

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Roots Analysis

FEBRUARY 13, 2023

Presently, more than 195 mRNA therapeutics / mRNA vaccines are under development or commercialized for the treatment of a variety of indications. As a result, there is an evident increase in the demand for mRNA manufacturing capacity.

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Pfizer

DECEMBER 13, 2021

Shot of a Lifetime: How Two Pfizer Manufacturing Plants Upscaled to Produce the COVID-19 Vaccine in Record Time. Shot of a Lifetime: How Two Pfizer Manufacturing Plants Upscaled to Produce the COVID-19 Vaccine in Record Time. They embarked on a sterilization process to make the vaccine safe for injection.

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The Pharma Data

JULY 21, 2021

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as “Biovac,” a Cape Town-based, South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 Vaccine for distribution within the African Union. CEO and Co-founder of BioNTech.

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Outsourcing Pharma

AUGUST 5, 2020

The firms are working to create a platform that gives the ability to monitor temperature-sensitive treatments, vaccines and other products.

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pharmaphorum

FEBRUARY 17, 2021

The European Commission has ordered another 200 million doses of the Pfizer/BioNTech COVID-19 vaccine Comirnaty, bringing the bloc’s total order to 500 million doses. The vaccine is based on BioNTech’s proprietary mRNA technology and was developed by both companies. Feature image copyright BioNTech SE 2020, all rights reserved.

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Outsourcing Pharma

FEBRUARY 18, 2021

With demand for fast-tracking therapies, vaccines and other products increasing, companies like Azzur Group offer the ability to add capabilities quickly.

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pharmaphorum

JUNE 2, 2021

Capacity to supply Moderna’s COVID-19 vaccine in Europe could be swelled by round 300 million doses a year, following an agreement to set up a new production line at contract manufacturer Lonza. Full approval means it could be used routinely in future as an annual booster, much like the seasonal influenza vaccine.

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The Pharma Data

JUNE 24, 2021

Effort is part of the companies’ recent pledge of two billion doses to ensure global equitable access to the vaccine. The government will, in turn, donate the Pfizer-BioNTech vaccine doses to low- and lower middle-income countries and organizations that support them. This press release features multimedia. Our partnership with the U.S.

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Pharmaceutical Technology

JANUARY 12, 2023

. – about the advantages and challenges of product lyophilization, developing lyophilization processes on site at their Bloomington, Indiana plant, and the importance of continuing research. Biologics often have strict temperature requirements to ensure the product remains stable. KB: Primarily stability.

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Roots Analysis

OCTOBER 3, 2023

Bioreactors and fermenters are complex systems used across numerous sectors of the industry, for the production of pharmaceuticals, nutraceuticals, food, and beverages. These systems provide controlled conditions for cell growth by providing optimum nutrient supply, and oxygenation, enabling the production of biologics.

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pharmaphorum

FEBRUARY 8, 2021

The UK has agreed a 50 million-dose order for a COVID-19 vaccine with German biotech CureVac to support development of a shot that specifically targets emerging variants of the virus. AZ has said it is confident however that it could quickly update its vaccine and have a new version ready for the autumn.

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The Pharma Data

MARCH 8, 2022

and manufacturer Aspen SA Operations (Pty) Ltd, based in South Africa, to enable the first COVID-19 vaccine to be manufactured and made available by an African company for people living in Africa, with the goal of increasing COVID-19 vaccination rates across the continent.

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Roots Analysis

JANUARY 24, 2024

Continuous manufacturing process involves the production of pharmaceutical drug substance in a single run, while operating 24×7. In this process, the drug is developed from its base ingredients / raw materials and processed to the final product in one facility, without any hold time.

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