Pharmaceutical Technology

NOVEMBER 25, 2022

All evidence indicated that containment in facilities is in high demand and will be increasingly so in the future as the oncology pipeline and the use of cytotoxic drugs continues to grow. Dedicated manufacturers are investing heavily in these services, powered by client requirements.

Manufacturing 130

Manufacturing Containment Contract Manufacturing Development 130

Pharmaceutical Technology

SEPTEMBER 14, 2022

Pharmaceutical drug research and development (R&D) activities are capital-intensive, which makes the outsourcing of clinical dose manufacturing and marketing popular. The download contains detailed information on the providers and their services and solutions, alongside contact details to aid your purchasing or hiring decision.

Marketing 100

Marketing Contract Manufacturing Sales Clinical Trials 100

Pharmaceutical Technology

SEPTEMBER 14, 2022

The dose form manufacturing follows API manufacturing to produce the final dosage form (FDF such as tablets and injectables. Commercial dose companies in contract marketing help in strategically positioning the products in the market, enabling patients to reap maximum benefit from it and transforming its sales management strategies.

Marketing 100

Marketing Contract Manufacturing Manufacturing Containment 100

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?.

Contract Manufacturing 130

Contract Manufacturing Manufacturing Production Packaging 130

Pharmaceutical Technology

SEPTEMBER 20, 2022

The increasing investment in pharmaceutical research and development, and the growing adoption of contract manufacturing and marketing practices are driving the demand for clinical trial contract packaging solutions. Finding the best clinical trial packaging services providers.

Packaging 100

Packaging Packaging Marketing Clinical Trials 100

Outsourcing Pharma

JANUARY 30, 2024

Two new offerings have been unveiled by drug delivery and solutions provider, Stevanto Group S.p.A.

Containment 59

Containment Packaging Packaging Drug Delivery 59

BioPharma Reporter

OCTOBER 2, 2024

The company, a provider of drug containment and delivery solutions, will introduce its expanded Vertiva 10mL on-body delivery system.

Containment 59

Containment Drugs Contract Manufacturing Manufacturing 59

Roots Analysis

DECEMBER 11, 2022

Concerns related to the cytotoxic nature of the payload; typically, such drug molecules require highly contained facilities and established working precautions and protocols to prevent exposure to hazardous levels of product (it is recommended that OELs be maintained in the range of 10-9 gram/m3).

Antibody 40

Antibody Marketing Contract Manufacturing Drugs 40

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.

Manufacturing 85

Manufacturing Containment Development Medicine 85

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.

Contract Manufacturing 52

Contract Manufacturing Manufacturing Marketing Containment 52

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.

Manufacturing 40

Manufacturing Production Contract Manufacturing Contamination 40

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.

Manufacturing 52

Manufacturing Containment Contract Manufacturing Development 52

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.

Manufacturing 52

Manufacturing Drug Delivery Systems Genetic Engineering RNA 52

Roots Analysis

AUGUST 29, 2024

These kits contain a sterilized vial filled with non-radionuclide component (carrier molecule) to which an appropriate radionuclide is added / diluted for the purpose of diagnostics, therapeutics and theranostics. Notably, close to 50% of these non-industry players are engaged in contract manufacturing of radiopharmaceuticals.

Production 52

Production Marketing Manufacturing Contract Manufacturing 52

Roots Analysis

OCTOBER 24, 2023

Considerations of Handling High Potency Active Pharmaceutical Ingredients HPAPIs have difficult handling requirements which require various measures to be taken into consideration such as primary containment measures and secondary containment solutions. Secondary containment strategy include personnel training and awareness programs.

Manufacturing 40

Manufacturing Hormones Contamination Containment 40

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.

Antibody 52

Antibody DNA Containment Manufacturing 52

Roots Analysis

FEBRUARY 28, 2024

FCR001 contains the donor’s CD34+ cells, facilitating cells, and αβ T cells. Given that stem cell therapy manufacturing requires highly regulated, state-of-the-art technologies, it is difficult for stakeholders to establish in-house expertise for large-scale manufacturing of stem cell therapies.

Clinical Trials 40

Clinical Trials Clinical Trials Trials Manufacturing 40

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.

Manufacturing 59

Manufacturing Production Drugs Contract Manufacturing 59

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.

Clinical Trials 52

Clinical Trials Clinical Trials Production Trials 52

The Pharma Data

JANUARY 5, 2021

“ This press release contains forward-looking statements about the future development of the Sartorius Group. Novasep is a global provider of cost-effective and sustainable manufacturing solutions for life sciences molecules and fine chemicals.

Life Science 40

Life Science Manufacturing Sales Contract Manufacturing 40

The Pharma Data

JANUARY 5, 2021

” This press release contains forward-looking statements about the future development of the Sartorius Stedim Biotech Group. Novasep is a global provider of cost-effective and sustainable manufacturing solutions for life sciences molecules and fine chemicals.

Manufacturing 40

Manufacturing Sales Contract Manufacturing Insulin 40

The Pharma Data

NOVEMBER 15, 2020

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.

Clinical Trials 40

Clinical Trials Clinical Trials Production Trials 40

The Pharma Data

DECEMBER 23, 2020

INOVIO is also assessing nonclinical efficacy of INO-4800 in several animal challenge models with Public Health England (PHE) and Commonwealth Scientific and Industrial Research Organization (CSIRO) in Australia.

DNA 40

DNA Vaccination Vaccine Immune Response 40

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.

Vaccination 89

Vaccination Vaccine Manufacturing Contract Manufacturing 89

The Pharma Data

DECEMBER 15, 2020

Lipidor has already cooperated with the contract manufacturer Aurena Laboratories regarding hand and skin disinfection sprays and veterinary care products. This disclosure contains information that Lipidor is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014).

Contract Manufacturing 52

Contract Manufacturing Manufacturing Production Drugs 52

XTalks

FEBRUARY 11, 2021

The RNA is transcribed from DNA in 40-liter vessels containing enzymes and chemicals over the course of three to four days. The vaccine is then ready to be filled into vials using a high-speed vial filling machine that dispenses six doses into each container. BioNTech is also launching a factory upgrade in Puurs, Belgium.

Manufacturing 52

Manufacturing Vaccination Vaccine DNA 52

The Pharma Data

OCTOBER 22, 2021

Pfizer-BioNTech COVID-19 vaccine; or regarding implicit unborn earnings from the contract manufacturing agreement with BioNTech for the Pfizer-BioNTech COVID-19 vaccine. There can be no guarantee that our manufacturing of the the Pfizer-BioNTech COVID-19 vaccine will be successful.

Vaccination 52

Vaccination Vaccine Filler Manufacturing 52

The Pharma Data

JULY 21, 2021

The information contained in this release is as of July 21, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. Pfizer Disclosure Notice. For more information, please visit www.BioNTech.de.

Vaccination 52

Vaccination Vaccine Manufacturing Clinical Trials 52

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. For more information, please visit www.benuvia.com.

Manufacturing 52

Manufacturing FDA Approval Trials Development 52

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.

Drugs 52

Drugs Manufacturing Drug Delivery Production 52

The Pharma Data

NOVEMBER 2, 2020

We will also use data provided by our Korean R&D and contract manufacturing partner as part of their extensive product development schedule and as part of the XPRIZE initiative. The same data that will be produced by the company’s Pennsylvania testing partner will be used for submissions to the EU and Russian Federation.

Manufacturing 40

Manufacturing Contract Manufacturing Production Engineer 40

The Pharma Data

JANUARY 24, 2021

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.

Sales 40

Sales Manufacturing Contract Manufacturing Containment 40

The Pharma Data

NOVEMBER 5, 2020

Cost of collaboration and contract manufacturing (COCM). $. The increase in cost of collaboration and contract manufacturing in the third quarter of 2020 was primarily due to the recognition of manufacturing costs associated with higher sales of Dupixent and recognition of costs in connection with manufacturing ex- U.S.

Sales 40

Sales Production Manufacturing Antibody 40

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.

Manufacturing 130

Manufacturing Vaccination Vaccine Packaging 130

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. AbbVie (North Chicago, Illinois) and Novartis (Basel, Switzerland) have also withdrawn from their businesses in Russia.

Pharma Production 305

Pharma Production Production Clinical Trials Clinical Trials 305

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.

Contract Manufacturing 130

Contract Manufacturing Manufacturing Protein Sales 130

The Pharma Data

MAY 4, 2021

billion, primarily driven by Pfizer CentreOne, Pfizer’s contract manufacturing operation, reflecting sales of legacy Upjohn products to Viatris (4) and remdesivir to Gilead Sciences Inc., DISCLOSURE NOTICE: Except where otherwise noted, the information contained in this earnings release and the related attachments is as of May 4, 2021.

Vaccination 40

Vaccination Vaccine Production Sales 40