Pharmaceutical Technology

SEPTEMBER 15, 2022

Research by GlobalData (Contract Small Molecule API Manufacturing Industry by the Numbers – 2021 Edition) shows that containment facilities are in high demand as the use of cytotoxic drugs continues to grow. This suggests a move towards high-value specialised manufacturing. Containment challenges.

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Pharmaceutical Technology

JULY 29, 2022

Despite the advanced stage of Covid-19 vaccination programmes in richer countries, which would suggest an approaching drop-off in contract manufacturing demand, there is still a considerable need for variant-specific boosters. Commercial dose manufacturing. Injectable sites receiving investment now and in the future.

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Roots Analysis

APRIL 15, 2024

Additionally, the fill finish manufacturing of biologics is a critical step in the production of biopharmaceuticals as it requires well-equipped facilities with adequate sterile filling and packaging lines to ensure sterility of the product while filling into the final containers.

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Pharmaceutical Technology

AUGUST 10, 2022

Working with a contract manufacturing organization (CMO) in the pursuit of bringing a new product to market can deliver a range of significant benefits. Drawings and/or part numbers of the selected container closure? The costing section, meanwhile, should contain technical transfer costs. Packaging needs?.

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Pfizer

JANUARY 17, 2023

Upon completion of the construction, the state-of-the-art facility will have extensive capabilities for producing biologics drug substance and provides additional manufacturing capacity allowing Pfizer to help accelerate its innovative pipeline. The information contained in this press release is as of January 17, 2023. Investments.

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Roots Analysis

OCTOBER 24, 2023

As the global market for pharmaceutical solutions is increasing, pressure to bring biological APIs in different biological forms is rising and with the rising demand of targeted therapies, antibody-drug conjugates (ADCs) and cytotoxic drugs have gained wide attention in the field of HPAPIs.

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FDA Law Blog

JANUARY 1, 2024

The letter also stated that the company’s response to the inspection report was “inadequate because it did not include a review of environmental monitoring data in your manufacturing areas, an adequate risk analysis of previously manufactured drug product, or testing of reserve samples from impacted batches.” Dextrum Laboratories Inc.

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The Pharma Data

AUGUST 7, 2020

to manufacture and supply Gilead’s investigational antiviral remdesivir, as one of multiple external manufacturing organizations supporting efforts to scale up supply of the investigational treatment for COVID-19. Pfizer Disclosure Notice: The information contained in this release is as of August 7, 2020.

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The Pharma Data

OCTOBER 22, 2021

BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of Emergency Use Authorizations or coequals in the United States ( concertedly with Pfizer) and other countries. The specifics will be bared when we conclude specific agreements.

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Pharmaceutical Technology

NOVEMBER 17, 2022

According to GlobalData analysis, specialist small molecule API capabilities such as containment or controlled substances are driving large contract manufacturing organisations (CMOs) to acquire facilities. Flexible containment solutions for potent APIs. Partnering with containment experts.

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Pharmaceutical Technology

SEPTEMBER 14, 2022

The growing demand for innovative drugs and a limited number of blockbuster drugs has led to the growth of the pharmaceutical contract manufacturing market, which has fuelled contract commercial dose manufacturing and marketing. Discover the leading commercial dose companies in contract marketing.

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pharmaphorum

JANUARY 19, 2021

They will announce further updates about European vaccine supplies and the companies said they are planning to add more vaccine suppliers and contract manufacturers to boost worldwide capacity. He called for a full commitment to the global vaccine-sharing scheme Covax, which is due to kick in next month.

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The Pharma Data

SEPTEMBER 11, 2021

This press release contains forward-looking statements. Any forward-looking statements contained in this press release speak only as of the date hereof, and Twist Bioscience specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

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The Pharma Data

NOVEMBER 2, 2020

With newly inspired technology, and diabetic test strips already in the final stages of development, DECN products compete on a worldwide scale with legacy manufacturers currently selling to 71+ percent of a $15+ billion at-home testing market. The company’s new GenViro! Inquiries may be directed to: info@decisiondiagnostics.co.

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The Pharma Data

JULY 21, 2021

Government at a not-for-profit price, that the government will, in turn, donate to the African Union and the COVAX 92 Advanced Market Commitment (AMC) countries, as well as a direct supply agreement with the COVAX facility for 40 million doses. The information contained in this release is as of July 21, 2021. Pfizer Disclosure Notice.

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The Pharma Data

JANUARY 24, 2021

Such regulatory approvals will allow for the roll out of the commercial test for multiple markets in the future. Therma Bright is also in the process of identifying component suppliers to be used in the large-scale manufacturing of the SCV2 test and is identifying contract manufacturers to manufacture and assemble the final product.

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Roots Analysis

FEBRUARY 15, 2022

Specifically, the multi-step process of production of cytotoxic payloads, which are used in ADCs, requires a contained environment, dedicated manufacturing facilities, specialized analytical and purification techniques, and storage facilities. As per the estimates, 70-80% of ADC manufacturing operations are outsourced.

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Pharmaceutical Technology

JULY 4, 2022

Russia is an already insular country and its worldview has tended to be self-contained, but this has hardened in the face of recent sanctions and counter-sanctions imposed during the war with Ukraine. Russian sites supply home market. Most pharma sites operating in Russia are owned by domestic companies.

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Roots Analysis

FEBRUARY 13, 2023

The key applications of mRNAs are below: Contract Manufacturing in mRNA Synthesis AND Manufacturing Service Domain The synthesis and manufacturing process of mRNA-based therapeutics / vaccines is complex and associated with several challenges.

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The Pharma Data

DECEMBER 23, 2020

INOVIO is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and diseases associated with HPV. . PLYMOUTH MEETING, Pa. , About INOVIO. View original content: [link].

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Roots Analysis

FEBRUARY 28, 2024

FCR001 contains the donor’s CD34+ cells, facilitating cells, and αβ T cells. As a result, stem cell therapy developers have begun outsourcing their manufacturing operations to contract manufacturing organizations (CMOs).

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The Pharma Data

NOVEMBER 5, 2020

Key Pipeline Progress Regeneron has more than 20 product candidates in clinical development, including five marketed products for which it is investigating additional indications. Cost of collaboration and contract manufacturing (COCM). $. Non-GAAP net income per share – diluted (1). $. Business Highlights.

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The Pharma Data

JANUARY 27, 2021

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Athersys has forged strategic partnerships and a broad network of collaborations to further advance the MultiStem cell therapy toward commercialization.

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The Pharma Data

JANUARY 27, 2021

For over a decade, the company and its team have been leaders in the design, testing and manufacture of thin film drug formulations, particularly transdermal patches and sub-lingual (oral) strips for the delivery of active pharmaceutical ingredients (“API”) for the treatment of pain and neurological conditions.

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The Pharma Data

JANUARY 5, 2021

based contract manufacturing business, Benuvia Manufacturing, which has significant chemistry and formulation capabilities, including manufacturing our FDA-approved cannabinoid drug, SYNDROS ® ,” said Todd C. We look forward to supporting Radius through our U.S. Benuvia Therapeutics Inc. Forward-Looking Statements.

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The Pharma Data

NOVEMBER 15, 2020

Prior to Celgene, she held leadership roles in marketing, sales and new business development from 2002 to 2011 at Johnson & Johnson. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Before that, Ms.

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Pharmaceutical Technology

APRIL 24, 2023

“Biologics products may contain proteins that control the action of other proteins and cellular processes, genes that control production of vital proteins, modified human hormones, or cells that produce substances that suppress or activate components of the immune system.

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Pharmaceutical Technology

DECEMBER 6, 2022

On the other hand, the current trend is for fully closed systems that use negative pressure to keep particles contained inside isolators. Many companies are now prioritising investments in containment systems, GlobalData research shows. But containment is not only important at commercial-stage manufacturing.

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The Pharma Data

MAY 4, 2021

Following the completion of the spin-off of the Upjohn Business (4) in the fourth quarter of 2020, Pfizer now operates as a focused innovative biopharmaceutical company engaged in the discovery, development, manufacturing, marketing, sales and distribution of biopharmaceutical products worldwide. in December 2019; and.

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The Pharma Data

JUNE 24, 2021

As part of the plan, the United States will allocate the vaccine doses to 92 low- and lower middle-income countries and economies as defined by Gavi’s COVAX Advance Market Commitment (AMC) and the 55 member states of the African Union. The information contained in this release is as of June 10, 2021. with distinct legal restrictions.

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Pharmaceutical Technology

APRIL 12, 2023

The ingredients used in these drugs are high potency, even at small doses, and pose a risk to both human health and cross-contamination with other drugs in a manufacturing environment. Currently mostly outsourced, there are signs that CMOs are beginning to make investments in containment capabilities, to capture emerging opportunities.

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Pharmaceutical Technology

JANUARY 12, 2023

KB: Some formulations contain low concentrations of the active ingredient. Download this whitepaper to find out more about oncology trends and how Baxter’s oncology contract manufacturing facility in Halle, Germany, minimise the risk of cross contamination. Why are bulking agents used in lyophilization? United Kingdom.

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Pharmaceutical Technology

JUNE 14, 2023

The number of high-potency drug approvals has increased over the last decade, driven by the increasing use of APIs (Active Pharmaceutical Ingredients) in the pipeline and among marketed drugs. Containment challenges and opportunities High containment facilities guard against exposure to extremely potent products and cross-contamination.

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