Pharmaceutical Technology

NOVEMBER 30, 2022

A vitally important assay used across various stages of drug development and manufacturing, container closure integrity testing (CCIT) involves evaluating packaging systems to determine their ability to protect the stability and sterility of pharmaceutical products. Many test methods have thus been developed.

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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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Pharmaceutical Technology

APRIL 26, 2023

Packaging plays a critical part in the pharmaceuticals and medical devices industries and is developed with its own set of security standards for the safety of consumers. The document contains detailed information on the providers and their product offerings, alongside contact details to aid your purchasing or hiring decision.

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Packaging Packaging Manufacturing Development 130

Pharma Mirror

SEPTEMBER 1, 2023

North Charleston, SC: Pharmaceutical sterilization and cleaning equipment manufacturer Belimed Life Science, North Charleston, SC, has unveiled custom wash rack design and manufacturing services.

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Pharmaceutical Technology

JUNE 14, 2023

This, coupled with small pharma companies being unable to acquire or access containment capabilities in-house, means that the demand for innovative specialized small molecule capabilities remains high. Premium specialized equipment is necessary because high containment facilities call for the separation of the operator from the product.

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Containment Manufacturing Contract Manufacturing Bioavailability 130

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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Contamination Manufacturing Containment Production 130

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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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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Development Packaging Packaging Generic Drugs 189

Drug Patent Watch

MARCH 12, 2025

Behind the scenes, generic drug manufacturers are working tirelessly to ensure that their products are safe, effective, and identical to their branded counterparts. For generic drug manufacturers, stability testing is a critical step in the development process. One crucial aspect of this process is stability testing.

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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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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

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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XTalks

JANUARY 21, 2025

TriClip G4 System Manufacturer/developer : Abbott Medical Date of FDA approval : April 1, 2024 Approved for : Tricuspid regurgitation (TR). Abbott Spinal Cord Stimulation (SCS) Systems Manufacturer/developer : Abbott Medical Date of FDA approval : May 30, 2024 Approved for : Chronic, hard-to-manage pain in the torso, arms and legs.

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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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Pharmaceutical Technology

MAY 24, 2023

Every major pharma company is now involved in CGT development which has resulted in the approval of 28 therapies by the FDA thereby making CGT no longer a niche category of therapies. Allogeneic therapies begin with healthy donor samples to develop the eventual therapeutic product which can be administered to multiple patients.

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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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Development Production Immune Response Licensing 161

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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Containment Manufacturing Production Contract Manufacturing 130

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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Development Genotoxicity Production Drugs 137

Roots Analysis

JANUARY 27, 2025

It is worth mentioning that the past few decades have witnessed several advances in this domain, particularly in the cell therapy manufacturing process. Steps Involved in Cell Therapy Manufacturing Process Manufacturing biologics and cell therapies is considerably complex when compared to small molecule drugs.

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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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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 14, 2022

As an autologous cell therapy, manufacturing the infusion product is a highly specialised process involving tumour harvest and the extraction and large-scale ex vivo expansion of TILs. This approach would not significantly alter the TIL manufacturing process or increase the time from tumour resection to TIL infusion. to more than 10%.

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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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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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Containment Packaging Packaging Drug Delivery Systems 52

Camargo

DECEMBER 9, 2020

Biopharma and manufacturing company Alkermes was recently able to participate in a remote document review for its ALKS 3831 product. Camargo can help you to develop the right pricing and access strategy for your product; contact us for more information. The firm supplied all the requested documentation, and the outcome was. Ken Phelps.

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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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Gene Therapy Gene Marketing Manufacturing 130

Pharmaceutical Technology

SEPTEMBER 5, 2022

Pharmaceutical wholesalers act as intermediaries between pharmaceutical manufacturers and retailers and facilitate the delivery of the right medicines in a timely, efficient, and secure manner. Wholesale distributors are responsible for guaranteeing product quality and preventing the influx of counterfeited drugs.

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Packaging Packaging Compliance Manufacturing 130

XTalks

SEPTEMBER 8, 2020

Albany Molecular Research Inc (AMRI), a global provider of advanced drug development and manufacturing solutions, announced that they have signed a supply agreement with AstraZeneca. The genetic material contains SARS-CoV-2 spike protein. The Phase 3 trial is being implemented as part of Operation Warp Speed.

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Manufacturing Vaccination Vaccine Allergies 83

FDA Law Blog

FEBRUARY 13, 2025

While a PCCP can address many types of post-market device changes, FDA specifically recognizes that software development is an iterative process, and software developers continually try to improve and update devices. FDA recommends including only a limited number of modifications in the PCCP.

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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

FEBRUARY 8, 2023

In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases. This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinical development.

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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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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

SEPTEMBER 15, 2022

The list includes suppliers of a wide range of pharmaceutical packaging, containers and containment solutions, including plastic, glass and other customised packaging solutions, as well as labelling and printing solutions. Pharmaceutical packaging formats and materials. Trends in pharmaceutical contract packaging.

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Packaging Packaging Marketing Containment 100

Pharmaceutical Technology

AUGUST 17, 2022

Such issues are not surprising when one considers that smoke in theatre - caused by the thermal destruction of tissue - can contain pollutants such as benzene, hydrogen cyanide, formaldehyde and bioaerosols. has been manufacturing, designing, and innovating since 1984.

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Contamination Containment Production Branding 245

Pharmaceutical Technology

SEPTEMBER 7, 2022

The download contains detailed information on the providers and their services and solutions, alongside contact details to aid your purchasing decision. Many companies use artificial intelligence (AI) to enable pharmaceutical manufacturers to overcome barriers to medication adherence. Patient adherence.

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Pharmaceutical Technology

SEPTEMBER 14, 2022

Victoza, Copaxone, Lupron, Zoladex, Sandostatin, and Somatuline are some of the popularly marketed peptide API therapeutic drugs while more than 600 peptide-based pharmacological leads are being investigated worldwide, across various phases of development. Discover the top API protein and peptide companies in contract marketing.

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