Drug Patent Watch

DECEMBER 17, 2024

Contract Development and Manufacturing Organizations (CDMOs) are at the forefront of this shift, playing a crucial role in bringing innovative therapies to market. Today, they’re strategic partners in drug development and manufacturing, offering end-to-end solutions that can make or break a pharmaceutical company’s success.

Manufacturing 90

Manufacturing Production Development Big Data 90

Pharmaceutical Technology

MARCH 22, 2023

The need for quality When it comes to injectable medicine, achieving product sterility through aseptic manufacturing is of critical importance. A poor choice of closure or a dimensional defect on a packaging component can impact the container’s integrity, causing leaks, oxidation, and/or contamination.

Contamination 130

Contamination Packaging Packaging Manufacturing 130

STAT News

AUGUST 15, 2022

A new report from the National Academies of Sciences, Engineering, and Medicine (NASEM) aims to change that. communities. Although researchers have known about the impact of these chemicals for years, there has been little guidance available for clinicians. Read the rest…

Contamination 98

Contamination Packaging Packaging Engineer 98

Pharmaceutical Technology

OCTOBER 28, 2022

It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Biosimilars are biologic medical products that almost exactly replicate products already being manufactured by other companies.

Bioequivalency 130

Bioequivalency Production Contamination Branding 130

XTalks

MARCH 25, 2022

Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process,” the company stated in a news release. Last summer, Pfizer recalled a dozen lots of its smoking cessation drug Chantix due to nitrosamine contaminants.

Contamination 95

Contamination Drugs Production Manufacturing 95

XTalks

DECEMBER 14, 2020

AvKARE, a generics pharmaceutical manufacturer based in Pulaski, Tennessee, has issued a recall on one lot each of its sildenafil 100 mg tablets and trazodone 100 mg tablets due to a packaging “mix-up” in which both drugs were filled into the same bottle. According to AvKARE, the error occurred at a third-party bottle filling facility.

Packaging 98

Packaging Packaging Drugs Generic Pharmaceutical 98

Pharmaceutical Technology

DECEMBER 20, 2022

Maintaining sterility is critical in the final steps of parenteral drug processing, ensuring doses are free from microbial contamination that could affect patient safety. With operator intervention being a primary source of contamination, finding ways to reduce human contact has been an ongoing challenge and goal in aseptic filling.

Regulation 130

Regulation Contamination Manufacturing Production 130

Pharmaceutical Technology

MARCH 23, 2023

When freeze drying sterile pharmaceuticals, mass spectrometry helps manufacturers protect valuable batches from silicone oil contamination – a possible risk of the lyophilisation process. Preventing silicone oil contamination Silicone oil is a common component of lyophilisation systems.

Contamination 130

Contamination Manufacturing Regulation Production 130

The Pharma Data

MARCH 29, 2022

an animal food manufacturing company of Carney’s Point, New Jersey, has agreed to stop selling, manufacturing and distributing raw pet food and come into compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). Food and Drug Administration (FDA) announced today that Bravo Packing, Inc.,

Manufacturing 52

Manufacturing Contamination Cosmetics Regulation 52

pharmaphorum

NOVEMBER 6, 2022

Eli Lilly plans for a new biopharmaceutical manufacturing facility in Ireland that will be used to produce active ingredients for its biologic medicines, including its new Alzheimer’s candidate donanemab, has been blocked by a planning objection.

Manufacturing 105

Manufacturing Contamination Development Medicine 105

Pharmaceutical Technology

MAY 2, 2023

The pharmaceutical industry is constantly striving for better, cleaner, safer manufacturing, especially when it comes to injectable medicines. Datwyler is a leading provider of parenteral packaging components and is helping the industry put quality first through the invention of the FirstLine® manufacturing standard.

Packaging 130

Packaging Packaging Production Contamination 130

Pharmaceutical Technology

MAY 17, 2023

In addition to revolutionising diabetes care, insulin has become an essential component of biopharmaceutical manufacturing, where its growth-supplementing ­­­properties are relied on to enhance commercially available cell culture media and achieve higher yields of target therapeutic proteins. One big challenge is contamination.

Insulin 130

Insulin Production Manufacturing Contamination 130

XTalks

FEBRUARY 21, 2022

BioNTech announced its new vaccine manufacturing approach in Africa where the company will ship modular factories, called the BioNTainer, to the continent to enable domestic production of the vaccines to help increase supplies. Each BioNTainer is a clean room equipped with state-of-the-art manufacturing solutions.

Vaccination 105

Vaccination Vaccine Production Manufacturing 105

XTalks

AUGUST 31, 2023

ModifyHealth, a leader in the burgeoning food as medicine industry, recently released four new meal plan offerings catering to a variety of dietary needs in the US. With the launch of these new meal plans, ModifyHealth solidifies its reputation as a frontrunner in the food as medicine industry.

Medicine 52

Medicine Production Contamination Branding 52

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. In contrast, most biologics are complex mixtures that are difficult to completely identify or characterize.

Development 180

Development Protein Production Hormones 180

Roots Analysis

JANUARY 12, 2023

The focus of stakeholders has now shifted to optimizing the cell therapies manufacturing process. For the success of cell-based therapies , an effective manufacturing platform and a robust supply chain model is imperative. The key steps involved in the supply chain of cell therapies manufacturing are presented below.

Manufacturing 40

Manufacturing Production Contamination Medicine 40

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.

Manufacturing 40

Manufacturing Production Contamination Gene Therapy 40

Roots Analysis

JUNE 6, 2024

Autoinjectors Market Manufacturers & Current Landscape Presently, close to 150 autoinjectors have been commercialized / being developed by more than 50 players for the treatment of various therapeutic areas, including diabetes, multiple sclerosis and rheumatoid arthritis.

Medicine 40

Medicine Drug Delivery Manufacturing Marketing 40

The Pharma Data

FEBRUARY 18, 2022

The company has introduced its approach to establishing scalable vaccine production by developing and delivering turnkey mRNA manufacturing facilities based on a container solution. The manufacturing solution consists of one drug substance and one formulation module, each called a BioNTainer.

Manufacturing 40

Manufacturing Vaccination Vaccine Production 40

pharmaphorum

JULY 21, 2022

This means there will be increased regulatory inspections over the next 12-18 months, so sites must reevaluate their quality and safety credentials and maintain a state of good manufacturing practice (GMP) readiness. in structural characterization of medicinal products and an MBA in management. Upgrading facilities. She has a Ph.D.

Compliance 98

Compliance Regulation Manufacturing Contamination 98

Pharmaceutical Technology

DECEMBER 6, 2022

Despite the current emphasis on biologic medicines, small molecule drugs still dominate the pharmaceutical manufacturing world. Manufacturing these highly potent and often cytotoxic drugs introduces many risks for operators and the environment. But containment is not only important at commercial-stage manufacturing.

Containment 130

Containment Development Drugs Contract Manufacturing 130

XTalks

DECEMBER 14, 2020

AvKARE, a generics pharmaceutical manufacturer based in Pulaski, Tennessee, has issued a recall on one lot each of its sildenafil 100 mg tablets and trazodone 100 mg tablets due to a packaging “mix-up” in which both drugs were filled into the same bottle. According to AvKARE, the error occurred at a third-party bottle filling facility.

Packaging 52

Packaging Packaging Drugs Generic Pharmaceutical 52

pharmaphorum

AUGUST 24, 2020

The conference is proudly chaired by Lynne Ensor, Vice President, Technical, Parexel International as a 21-year veteran of the FDA, her areas of expertise include biopharmaceutical sterile product manufacturing and testing, pharmaceutical microbiology, pharmacy compounding, and regulatory policy development. in Biology and Ph.D.

Contamination 52

Contamination In-Vitro Production Containment 52

XTalks

OCTOBER 8, 2024

In the statement announcing approval of the mpox test, WHO Access to Medicines and Health Products assistant director-general Dr Yukiko Nakatani said, “This first mpox diagnostic test listed under the Emergency Use Listing procedure represents a significant milestone in expanding testing availability in affected countries.

In-Vitro 98

In-Vitro DNA Contamination Manufacturing 98

Pharmacy Checkers

DECEMBER 12, 2019

Importing medicines from countries that do not have our same strong standards could taint our medicine supply.”. The second sentence is deceptively broad: as in, yes, importing medicines from countries that do not have our “same” standards could taint our medicine supply. Not necessarily, but it could. If the U.S.

Drugs 71

Drugs Manufacturing Medicine Regulation 71

pharmaphorum

SEPTEMBER 9, 2022

Water-borne illnesses are also likely to become more common, as increased rain and storm surges contribute to flooding and contaminated run off. In 2017, the global medicines supply was interrupted when Hurricane Maria hit Puerto Rico, home to more than 500 medical product facilities and producer of 10% of all drugs consumed in America.

Production 105

Production Pharma Companies Medicine Generic Drugs 105

The Pharma Data

AUGUST 21, 2020

However, in this week’s round up, Pharma IQ shares promising news of a Covid-19 candidate collaboration between Roche and Regeneron that looks to boost manufacturing and delivery efforts to patients in need of a cure. Roche and Regeneron join forces to increase global supply of an antibody cocktail for Covid-19. Sign up now. Source link.

Vaccination 52

Vaccination Vaccine Manufacturing Contamination 52

Pharmacy Checkers

NOVEMBER 21, 2019

The FDA’s capacity to evaluate new and generic drug applications and its oversight over drug manufacturing are why we have this degree of assurance. Just as there is not a completely safe and effective drug, there is not an unequivocally foolproof system to make sure every single drug is manufactured at the highest quality.

Generic Drugs 68

Generic Drugs Manufacturing Drugs Regulation 68

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

Pharmaceutical Technology

APRIL 16, 2023

The question now is how to best design and manufacture autoinjectors that can be used to safely store and administer these larger volumes. Conventional cartridge-based solutions are complex and require users to manually attach the needle to the device, risking contamination and injuries. SHL Medical’s Molly 2.25 Autoinjector 3.

Protein 130

Protein Containment Drug Delivery Drugs 130

The Pharma Data

DECEMBER 30, 2020

. “This is very good news for the world — it makes a global approach to a global pandemic much easier,” Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, told the Times. More Dangerous Mouthwashes and Hand Sanitizers Recalled.

Contamination 52

Contamination Vaccination Vaccine Pharmacy 52

Advarra

SEPTEMBER 14, 2023

GxP in Medical Devices It’s no surprise: Developing and manufacturing medical devices is so highly regulated , and this regulatory approach extends to the recent proliferation of medical devices created using artificial intelligence and machine learning (AI/ML). Working together, the U.S.

Clinical Research 52

Clinical Research Research Compliance Clinical Trials 52

pharmaphorum

JANUARY 17, 2022

The case was brought by the US Federal Trade Commission (FTC) and US states New York, California, Illinois, North Carolina, Ohio, Pennsylvania and Virginia, for Shkreli’s actions that blocked any competition with its key medicine to preserve monopoly profits. Many people carry the illness but do not exhibit symptoms.

Bioequivalency 45

Bioequivalency Generic Drugs Contamination Drugs 45

XTalks

OCTOBER 16, 2020

Ebola virus is transmitted through direct contact with blood, body fluids and tissues of infected people or wild animals, as well as with surfaces and materials – such as bedding and clothing – contaminated with these fluids. Results from the trial were published in the New England Journal of Medicine in December, 2019.

Antibody 98

Antibody Drugs Clinical Trials Clinical Trials 98

Roots Analysis

JANUARY 17, 2024

They offer several advantages over traditional drug delivery systems ( such as vials and syringes ), including reduced chances of dosing errors, increased patient compliance and decreased risk of microbial contamination. These syringes also have low risk in supply chain and streamlined regulatory process ( when compared to other materials ).

Drug Delivery 40

Drug Delivery Contamination Drugs Production 40

Creogenic Pharma

APRIL 15, 2023

At Creogenic Pharma, we have a dedicated workforce of professionals and a cGMP compliant manufacturing facility. We also have contamination-free spacious warehouses and link-ups with certified vendors in the industry. This wide range of medicine is essential for any business in the pharmaceutical sector.

Pharma Companies 40

Pharma Companies Pharma Production Medicine Production 40

The Pharma Data

JANUARY 27, 2021

The two-hour event will cover various topics, including an overview of the Company’s board and executive leadership, its commitment to environment, social and governance (ESG) matters, and progress updates on the Company’s critical care programs, manufacturing and distribution approach, and commercial readiness plans. 28, 2021 11:00 UTC.

Clinical Trials 52

Clinical Trials Clinical Trials Production Trials 52