Roots Analysis

DECEMBER 11, 2022

Antibody drug conjugates (ADCs) are an upcoming class of targeted therapeutic agents that have garnered the attention of pharmaceutical companies, and academic / research institutions across the world. Antibody drug conjugates market is presently an established therapeutic concept with 11 approved products.

Antibody 40

Antibody Marketing Contract Manufacturing Drugs 40

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

Roots Analysis

APRIL 15, 2024

These complex entities, such as antibodies, antibody drug conjugates, cell therapies, gene therapies, and therapeutic proteins, are highly specific molecules that are designed to precisely target biomarkers associated with a particular disease pathway.

Manufacturing 40

Manufacturing Production Contract Manufacturing Contamination 40

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

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

Drug Discovery World

DECEMBER 14, 2023

With leading academic institutions and significant recent investment, Glasgow is shaping up to be an important centre for drug discovery and development in the UK. Discoveries in these areas will identify new treatments which will become the cancer drugs of the future.” DDW’s Diana Spencer explores the city’s unique ecosystem.

Drugs 75

Drugs Life Science Research Scientist 75

Roots Analysis

OCTOBER 24, 2023

Owing to the advancement in clinical pharmacology and oncology domain, and the rising demand for targeted therapeutics and precision medicines, high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have become one of the key areas of interest to researchers and drug manufacturers across the globe.

Manufacturing 40

Manufacturing Hormones Contamination Containment 40

FDA Law Blog

JANUARY 1, 2024

Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. The FDA compliance data, sorted by category, shows there were 159 Warning Letters issued to drug manufacturers or sponsors during 2023, with 161 issued in calendar year 2022.

Manufacturing 59

Manufacturing Production Drugs FDA Compliance 59

Pfizer

JANUARY 17, 2023

Pfizer to Acquire Sanford, North Carolina Manufacturing Site from Abzena. Share. • State-of-the-art biologics drug substance facility will produce Pfizer’s innovative pipeline products and provide additional capacity for in-line medicines. • Expected to more than double the current workforce of new facility by 2025. About Abzena.

Manufacturing 85

Manufacturing Containment Development Medicine 85

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 Contract Manufacturing 52

The Pharma Data

SEPTEMBER 11, 2021

“Boehringer Ingelheim believes Twist’s ability to generate potent, diverse therapeutic antibodies by mining its comprehensive libraries, combined with our extensive capabilities and experience in drug discovery and development, will enable us to deliver breakthrough opportunities to patients,” said Clive R. Wood, Ph.D., Leproust, Ph.D.,

Antibody 52

Antibody DNA Containment Manufacturing 52

The Pharma Data

JANUARY 5, 2021

Efficient downstream processing has remained a challenge in our industry for years, and Sartorius Stedim Biotech is committed to helping accelerate and simplify this crucial step so that new drugs can be manufactured much more efficiently.”

Manufacturing 52

Manufacturing Sales Contract Manufacturing Insulin 52

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

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

The Pharma Data

JULY 21, 2021

Biovac will obtain drug substance from facilities in Europe, and manufacturing of finished doses will commence in 2022. The information contained in this release is as of July 21, 2021. This press release contains “forward-looking statements” of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995.

Manufacturing 52

Manufacturing Vaccination Vaccine Clinical Trials 52

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

The Pharma Data

JANUARY 27, 2021

Construction of commercial drug manufacturing facility in Germany. Development of oral biosensor and contract development & manufacturing. Psychedelic transdermal and sublingual drug formulation development. Four clinical studies in neurological indications in 2021.

Drugs 52

Drugs Manufacturing Drug Delivery Production 52

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. Several global pharma companies have already withdrawn their support following Russia’s invasion of Ukraine, which began on 24 February.

Pharma Production 305

Pharma Production Production Clinical Trials Clinical Trials 305

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

The Pharma Data

NOVEMBER 5, 2020

Food and Drug Administration (FDA) granted Breakthrough Therapy designation for the treatment of patients 12 years and older with eosinophilic esophagitis (EoE). In July 2020 , the Company announced an agreement whereby the Company was awarded a $450 million contract to manufacture and supply REGN-COV2 to the U.S. government.

Sales 52

Sales Production Manufacturing Antibody 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

JANUARY 5, 2021

Prader-Willi syndrome (“PWS”) will be the initial indication, which has been granted Orphan Drug and Fast Track Designation by the FDA. Food and Drug Administration (“FDA”). This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

Manufacturing 52

Manufacturing FDA Approval Trials Development 52

The Pharma Data

JANUARY 5, 2021

. “The Novasep portfolio will perfectly complement our existing chromatography offering and allow us to provide customers with more options for their manufacturing processes. “ This press release contains forward-looking statements about the future development of the Sartorius Group.

Life Science 52

Life Science Manufacturing Sales Contract Manufacturing 52

The Pharma Data

NOVEMBER 15, 2020

drug development initiative from 2012 to February 2019. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. More information is available at www.athersys.com. Follow Athersys on Twitter at www.twitter.com/athersys.

Clinical Trials 40

Clinical Trials Clinical Trials Production Trials 40

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

Pharmaceutical Technology

DECEMBER 6, 2022

Despite the current emphasis on biologic medicines, small molecule drugs still dominate the pharmaceutical manufacturing world. HPAPIs may now represent more than 30% of the drug development pipeline. Nowadays, you have drugs against cancer which have a very high impact even at a very low dosage.”.

Containment 130

Containment Development Drugs Contract Manufacturing 130

The Pharma Data

JUNE 24, 2021

The production capacity has consistently grown due to continued enhancements to the vaccine’s supply chain, which include expanding existing facilities, adding more suppliers, and bringing on additional Pfizer/BioNTech sites and contract manufacturers around the world to produce the vaccine. with distinct legal restrictions.

Vaccination 52

Vaccination Vaccine Manufacturing Clinical Trials 52

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., The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in August 2021. Pipeline Developments.

Vaccination 40

Vaccination Vaccine Production Sales 40

Pharmaceutical Technology

APRIL 12, 2023

Evidence suggests that API manufacturing is gaining in complexity, as well as sophistication, and therefore adding to the risk profile of drug development. Currently mostly outsourced, there are signs that CMOs are beginning to make investments in containment capabilities, to capture emerging opportunities.

Manufacturing 130

Manufacturing Production Containment Contamination 130

Pharmaceutical Technology

JANUARY 12, 2023

PM: Lyophilization is widely used in the pharmaceutical and biotech industry for small molecule drug products, vaccines, antibodies, and other biological material. KB: Some formulations contain low concentrations of the active ingredient. Manufacturing of Cytotoxic and Non-Cytotoxic Drugs in a Multiproduct Facility.

Production 130

Production Contamination Development Manufacturing 130

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. Premium specialized equipment is necessary because high containment facilities call for the separation of the operator from the product.

Containment 130

Containment Manufacturing Contract Manufacturing Bioavailability 130