Drug Discovery World

AUGUST 4, 2022

It may seem counterintuitive to spend time and money on planning for containment and delivery systems for a drug in the earliest stages of discovery when the chances of that molecule making it to market are still quite low. However, starting early can greatly improve the efficiency and speed of the development process. Never too early.

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Pharmaceutical Technology

FEBRUARY 3, 2023

Additionally, OSD manufacturing approaches are well developed, with processes that ensure a repeatable distribution of ingredients, uniformity in dissolution, and bioavailability, which verify that the drug product is safe and effective. Compared to other dosage forms, tablets are simpler to manufacture, package, and transport.

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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

SEPTEMBER 8, 2022

Pharmaceutical solid dose manufacturing companies in contract marketing segment have gained a vital position in pharmaceutical formulations. Find the leading pharmaceutical solid dose manufacturing companies in contract marketing. Growth of oral solid dosage contract manufacturing in the pharmaceutical industry.

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Pharmaceutical Technology

OCTOBER 6, 2022

from the US National Institutes of Health (NIH) unit National Institute of Allergy and Infectious Diseases (NIAID) to develop a prophylactic intranasal vaccine against Neisseria gonorrhoeae (NG). Leveraging its outer membrane vesicles (OMV) platform technology, Intravacc will develop the vaccine.

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Pharmaceutical Technology

DECEMBER 12, 2022

Gilead company Kite has entered an international strategic partnership with Arcellx for the joint development and commercialisation of the latter’s T-cell therapy, CART-ddBCMA, to treat relapsed or refractory multiple myeloma patients. Kite will carry out the manufacturing following the technical transfer.

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Pharmaceutical Technology

APRIL 24, 2023

Biologics are costly to produce and sell, and the more recent modalities, such as cell and gene therapies, can be difficult to manufacture. With new drugs on the market, companies are now looking for ways to manufacture recently approved biologics, and countries are racing to claim their corner – or maintain their decades-old market share.

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Pharmaceutical Technology

NOVEMBER 22, 2022

Vaccines are our number one weapon in the fight against infectious diseases, but their development has historically involved a long and complex process taking up to a decade. Before COVID-19, Merck held the record for the fastest modern vaccine ever developed. million in funding to support this work.

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Pharmaceutical Technology

NOVEMBER 25, 2022

PDF scale and reformulation challenge manufacturers. But the challenges for drug producers developing PDFs are numerous and varied. Formulation decisions made in the development of PDFs can have important implications for drug stability, patient compliance, and accurate dosing.

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Camargo

NOVEMBER 15, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. The guidance also contains some useful information, despite the limitations described above. FDA Publishes ICH Guidelines on Continuous Manufacturing.

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Roots Analysis

FEBRUARY 16, 2022

In earlier times, container closure integrity testing was not regarded as an essential step in the process of manufacturing. The company developing drug product through such an intense process, use to consider container closure system only for packaging of the product. [1]

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Roots Analysis

APRIL 15, 2024

Further, the manufacturing of biologics fill finish is a highly complex and cost-intensive process. Notable examples of fill finish manufacturing companies equipped with SA25 aseptic filling workstation include ( in alphabetical order ) Emergent Bioservices, PCI Pharma Services, Singota Solutions and WuXi Biologics.

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Pfizer

JANUARY 17, 2023

Pfizer to Acquire Sanford, North Carolina Manufacturing Site from Abzena. Pfizer to Acquire Sanford, North Carolina Manufacturing Site from Abzena. NYSE: PFE) and Abzena today announced that the companies have entered into an agreement under which Pfizer will acquire Abzena’s manufacturing facility in Sanford, North Carolina.

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The Pharma Data

MAY 15, 2023

Sandoz strengthens pipeline expansion through partnership to develop and manufacture multiple biosimilars Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announced a multi-year partnership with Just – Evotec Biologics, the Seattle-based subsidiary of Evotec SE.

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Pharmaceutical Technology

AUGUST 3, 2022

The potential to use these scientific breakthroughs to make a real difference to patients’ lives is what drives many highly skilled scientists to the world of drug development. This is where the process development stage, which directly follows the drug discovery and early formulation work, can make or break a drug’s success.

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Camargo

OCTOBER 14, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Continued development of the use of complex innovative trial designs. Continue development of the use of Real-World Evidence. Orientation.

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Roots Analysis

JANUARY 15, 2024

Although biopharmaceuticals offer significant profit margins and have demonstrated the potential to treat a myriad of disease indications, they are generally associated with high costs of development and complex manufacturing protocols.

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The Pharma Data

DECEMBER 4, 2021

company (NASDAQ: AMZN), announced that it is working with Pfizer to create innovative, cloud-based solutions with the potential to improve how new medicines are developed, manufactured, and distributed for testing in clinical trials. (AWS), an Amazon.com, Inc.

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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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Camargo

NOVEMBER 29, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. Essentially, a biologic is a product that is produced from living organisms or that contains components of living organisms.

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Pfizer

AUGUST 22, 2022

Hospira Issues A Voluntary Nationwide Recall For One Lot of Propofol Injectable Emulsion (containing benzyl alcohol), Due To The Potential Presence of Visible Particulates. It is a sterile, nonpyrogenic emulsion containing 10 mg/mL of propofol suitable for intravenous administration supplied in a Single Patient Use Glass Fliptop Vial.

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Camargo

DECEMBER 10, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. And the issues have impacted not only sponsors but also API manufacturers and CMOs; Camargo has direct experience with several such situations.

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Pharmaceutical Technology

APRIL 14, 2023

Ghana’s Food and Drug Authority (FDA) has approved R21/Matrix-M malaria vaccine in children aged 5 to 36 months, marking the first regulatory clearance for the University of Oxford-developed vaccine in any country in the world. Observers expect this will allow mass-scale manufacturing at modest cost, thereby turning the tide against malaria.

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Pharma Mirror

NOVEMBER 4, 2022

Terumo Pharmaceutical Solutions (TPS), a division of Terumo Corporation (TSE: 4543) and a leading manufacturer of injection, primary container, and infusion therapy devices, has today announced it will expand its contract development and manufacturing services for parenteral drugs to global customers.

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The Pharma Data

OCTOBER 26, 2020

Under the terms of the agreement, Novasep will be in charge of developing and manufacturing (cell culture, AAV expression, purification, aseptic distribution and quality control) the two AAV vectors designed for the Sensorion OTOF-GT project and will supply Drug Product batches to support preclinical and clinical studies. Disclaimer.

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Pharmaceutical Technology

SEPTEMBER 15, 2022

The document contains detailed information on the suppliers and their products, alongside contact details to aid your purchasing or hiring decisions. The post Leading API chemical companies in contract marketing appeared first on Pharmaceutical Technology.

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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. A revolutionary development.

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Drug Discovery World

JANUARY 19, 2023

This paid-for advertorial by Catalent appeared in DDW Volume 24 – Issue 1, Winter 2022/2023 One significant challenge in the manufacturing of cell and gene therapies is the production of high-quality plasmid DNA (pDNA). Figure 1: The integrated development pathway for cell and gene therapies. coli cell bank that contains the plasmid.

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Drug Discovery World

OCTOBER 19, 2022

Yapan Bio has expanded its capabilities with a new process development facility at Genome Valley, Hyderabad, India, which has enhanced its ability to support end-to-end development and manufacturing of RNA, DNA and gene therapy products starting from plasmids. .

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Camargo

APRIL 20, 2021

This trend progressively reduces the attractiveness of engaging in the early stages of oncology therapy development in the eyes of Big Pharma and opens the space for small pharma and biotech players. Become Fluent in the Drug Development “Languages.”. The language of accounting, to optimally allocate capital to maximize results.

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Pharmaceutical Technology

SEPTEMBER 14, 2022

Commercial dose companies form a critical component of the pharmaceutical manufacturing industry’s value chain. The dose form manufacturing follows API manufacturing to produce the final dosage form (FDF such as tablets and injectables. Discover the leading commercial dose companies in contract marketing.

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XTalks

JULY 15, 2021

University of Newcastle researchers in Australia have developed a saliva test to evaluate glucose levels in diabetic patients. The test involves the use of testing strips that contain a glucose biosensor with electronic elements in the test’s transistor, like inks, that allow for mass printing of the test strips at low cost.

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Pharmaceutical Technology

SEPTEMBER 8, 2022

Biologics development is a complex and expensive process. The list includes providers of development services, biologics management supply chain solutions, clinical trial services, commercial and logistics services, as well as packaging, labelling and distributing services for biologics.

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Pharmaceutical Technology

OCTOBER 26, 2022

New doors were opened in the 2000s with the development of genome editing, such as CRISPR-Cas9, which introduces molecular tools to change existing DNA. Today, the number of FDA and EMA-approved gene therapies is on the rise, with many more currently under development. Collaboration and integrated manufacturing.

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Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. Regulatory Considerations for Biologics. BLA process (CBER). 510(k) process (CBER). Premarket Approval (PMA) process (CBER).

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Pharmaceutical Technology

SEPTEMBER 6, 2022

The pharmaceutical supply chain is a global and complex network that includes a wide range of stakeholders such as pharmaceutical manufacturers, wholesale distributors, and pharmacy benefit managers (PBM), to ensure efficient and timely delivery of medications to the patients. Rise of pharma cold chain logistics companies.

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Roots Analysis

SEPTEMBER 20, 2023

The focus of stakeholders has now shifted to optimizing the cell therapy manufacturing process. It is worth noting that manufacturing process biologics and cell therapies is considerably complex when compared to small molecule drugs. The key steps involved in the supply chain of cell therapy manufacturing are presented below.

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