XTalks

AUGUST 12, 2024

Lead, a toxic metal, can enter the food supply through environmental contamination during the growing, raising or processing of foods. FDA’s Regulatory Framework on Lead in Food Lead contamination in food can arise from various environmental sources, including past usage of lead in paint, gasoline and plumbing materials.

Contamination 105

Contamination Compliance Regulation Production 105

XTalks

MAY 18, 2023

Cornell University researchers have been making strides in the development of a revolutionary tool to combat dangerous pathogens in commercial dry food manufacturing plants. Food manufacturers use steam for tasks like dehydration, distillation, pasteurization and cooking, which helps preserve the taste and texture of their offerings.

Manufacturing 52

Manufacturing Contamination Production Packaging 52

pharmaphorum

FEBRUARY 15, 2022

It’s not the first time that pharma ingredients have been found in the world’s waterways, but is the largest and most comprehensive assessment of pharmaceutical pollution to date, according to the international research team that spanned 86 academic groups.

Contamination 105

Contamination Manufacturing Scientist Research 105

Pharmaceutical Technology

FEBRUARY 3, 2023

Researchers have relentlessly worked through the barriers to create lifechanging treatments for patients in need. “As CAR T based therapies manufactured with lentiviral vectors are also on the rise, points out Clive Glover, PhD, General Manager, Pall Corporation. Biores Open Access. 2020 Oct 16;9(1):219-228. doi: 10.1089/biores.2020.0031.

Genome 244

Genome Genomics Medicine Gene Therapy 244

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. This adds costs and time to the processes involved.

Containment 130

Containment Manufacturing Production Contract Manufacturing 130

XTalks

MARCH 10, 2022

In the last decade, next generation sequencing (NGS) has gone from being solely a research tool to becoming routinely applied in many fields, including food safety testing. Traditional food safety testing methods used in manufacturing facilities are inconsistent, time consuming and often require trained technicians.

Manufacturing 98

Manufacturing Genome Genomics Contamination 98

XTalks

AUGUST 10, 2020

As our knowledge of the health effects of PFAS evolves, understanding how they get into our bodies and the environment — where they may contaminate crops and water supplies — is critical. Some research has shown that people who cook at home more often may have lower levels of PFAS in their bodies. Getting PFAS Out of Food Packaging.

Packaging 98

Packaging Packaging Contamination Containment 98

Pharma Times

DECEMBER 15, 2023

Funded by the UK Research and Innovations’ (UKRI) Engineering and Physical Sciences Research Council (EPSRC), the platform will decontaminate the air of pathogens and measure air quality to ensure a safer and healthier environment.

Contamination 90

Contamination Engineer Research Manufacturing 90

pharmaphorum

OCTOBER 14, 2022

DiCE includes 20 organisations from nine countries, representing the manufacturing industry, research, and recycling sectors. — Circular Digital Health (DiCE project) (@circular_health) October 13, 2022. ” A central objective of DiCE is to extend a product’s lifetime. .”

Contamination 124

Contamination Production Development Manufacturing 124

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

Pharmaceutical Technology

JANUARY 12, 2023

Research Associate III, who is a parenteral fill/finish and lyophilization specialist at Baxter BioPharma Solutions (BPS) – a business unit of Baxter Healthcare, Inc. That would not allow sufficient time to manufacture, package and distribute before half of the content was degraded. Why is continuing research so important?

Production 130

Production Contamination Development Manufacturing 130

XTalks

JUNE 14, 2022

Researchers at the Karolinska Institutet in Sweden developed a new nano-sensor for detecting pesticides on produce in a matter of minutes. While still at an early stage, the researchers hope these nano-sensors could help uncover pesticides before consumption. So, why is it important to detect pesticides on food before consumption?

Contamination 98

Contamination Research Production Manufacturing 98

Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

Clinical Research 52

Clinical Research Research Compliance Clinical Trials 52

Camargo

NOVEMBER 29, 2021

Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available. Biologic products are used for the prevention or treatment of numerous diseases and conditions, including: Cancer.

Development 180

Development Protein Production Hormones 180

Pharmaceutical Technology

NOVEMBER 15, 2022

Manufacturers are actively looking at ways they can improve drug delivery through well-designed parenteral packaging systems, and the choice to deploy prefilled syringes for more and more injectable drug products is a key part of this push. However, they are not always a first choice. When launching a new vaccine, vials tend to be chosen.

Packaging 130

Packaging Packaging Vaccination Vaccine 130

XTalks

MAY 30, 2023

The VTT Technical Research Centre of Finland has addressed this issue by developing a fully recyclable, modular ECG patch constructed from VTT’s novel cellulose e-skin material. Unfortunately, about 91 percent of this plastic waste from healthcare is not recycled and either ends up in landfills or contaminates natural environments.

Drug Delivery 98

Drug Delivery Drug Delivery Systems Manufacturing Contamination 98

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

OCTOBER 24, 2023

The limitations of stainless-steel bioreactors such as high risk of contamination, process related challenges and high operational cost have prompted innovators to develop more advanced single use bioreactor in order to meet the rising demand for safe and efficacious biotherapeutics.

Manufacturing 40

Manufacturing Contamination Marketing Production 40

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. Cross-contamination of standard products with highly potent ones is another key concern.

Containment 130

Containment Development Drugs Contract Manufacturing 130

pharmaphorum

JUNE 8, 2022

Driving a Holistic Approach to Assurance of Product Sterility through Aseptic Manufacturing following QRM Principles. Join us to discuss and address the Guidance and Regulation including the EU GMP Annex 1, environmental control delving into the contamination control strategy, Pharma moving forward 4.0 Leaders in Sterility Assurance.

Compliance 52

Compliance Contamination Manufacturing Production 52

The Pharma Data

DECEMBER 23, 2020

The FDA rapped California-based drug manufacturer Sky Systems in a Form 483 with a dozen observations after an inspection revealed the firm lacked a quality control unit. The investigator found the facility had no procedures in place to conduct annual reviews of products and had missing or incomplete batch production records. Jason Scott.

Contamination 52

Contamination Manufacturing Production Drugs 52

pharmaphorum

AUGUST 4, 2022

For instance, in pharmaceutical manufacturing, mistakes in training can lead to contamination or waste, which can cause businesses unnecessary headaches. The sheer pressure on the pharmaceutical industry to innovate caused a surge of job roles in IT, research and development (R&D), sales, and marketing.

Development 98

Development In-Vitro Manufacturing Compliance 98

FDA Law Blog

JULY 18, 2023

Claud — The Office of Pharmaceutical Quality (OPQ), located within FDA’s Center for Drug Evaluation and Research (CDER), uses global inspection, surveillance, policy, and research activities to set quality standards for drugs. That leaves 60% that manufacture at least one application product. By John W.M. and South Korea.

Manufacturing 52

Manufacturing Production Contamination Drugs 52

FDA Law Blog

JUNE 17, 2024

Claud — FDA’s Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) is charged with assuring that drugs marketed in the U.S. The Quality Report includes a rundown of what the universe of FDA-registered drug manufacturing sites looks like as included in the CDER Site Catalog. By Kalie E.

Manufacturing 59

Manufacturing Drugs Production Contamination 59

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. Warning Letters, generally made public in a batch each Tuesday, are FDA’s public sanction that is most widely used to bring pressure on manufacturers and clinical trial investigators.

Manufacturing 59

Manufacturing Production Drugs Contract Manufacturing 59

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

The Pharma Data

MAY 3, 2021

Included were articles on the mid-career transition from research scientist to regulatory professional, continuous professional development and the value of graduate-level qualifications, and findings from two surveys on different aspects of the profession. Reviewing nitrosamine contamination. Continuous professional development.

Development 52

Development Contamination In-Vitro Production 52

XTalks

AUGUST 11, 2023

These outstanding dips are for the big flavor fans out there,” said Sabra’s global chief research, development and sustainability officer Olugbenga Diyaolu, in a press release. “As The cause for concern this time was the possibility of Salmonella contamination.

Marketing 96

Marketing Branding Production Sales 96

The Pharma Data

AUGUST 21, 2020

As the pharma community continue to research and develop hundreds of potential therapies to combat the Covid-19 pandemic, very few initiatives are yet to cross the finishing line into the commercial market. Roche and Regeneron join forces to increase global supply of an antibody cocktail for Covid-19. Sign up now. Secure your free seat today.

Vaccination 52

Vaccination Vaccine Manufacturing Contamination 52

FDA Law Blog

MAY 23, 2023

Part 117, and the Food Allergy Safety, Treatment, Education and Research Act (2021). the product label declares “tree nut” or “fish” but fails to declare the type of tree nut or species of fish in either the ingredient list or in a separate “Contains” statement).

Containment 45

Containment Contamination Manufacturing Compliance 45

pharmaphorum

OCTOBER 7, 2020

Pepa has 15 years of combined experience in Regulatory Affairs (CMC) and multiple aspects of drug development and research and has participated in the approval of 15 original and biosimilar biologic license applications, focusing on microbiology product quality and sterility assurance aspects.

Contamination 52

Contamination Production Manufacturing Compliance 52

Pharmacy Checkers

DECEMBER 12, 2019

The FDA’s continuing problems with inspections of drug manufacturing plants, as well as the relative comparative strength of other drug regulators, ought to inspire serious reflection, even introspection, among drug safety policy professionals about whether or not, and how, we have the gold standard. Why do I write “exact same”?

Drugs 71

Drugs Manufacturing Medicine Regulation 71

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

XTalks

OCTOBER 16, 2020

In the Ebola trial, US researchers worked in conjunction with international aid groups and investigators from the DRC to test the drug alongside the other antiviral treatments. Remdesivir was granted emergency use authorization (EUA) in May 2020 by the FDA for the treatment of hospitalized COVID-19 patients with severe disease.

Antibody 98

Antibody Drugs Clinical Trials Clinical Trials 98

Roots Analysis

JUNE 6, 2024

Roots Analysis added The autoinjectors market research report forecast period from 2024 to 2035. Examples of some partnerships in this domain include: In January 2024, SHL Medical partnered with FUJIFILM Diosynth Biotechnologies to enhance the former company’s manufacturing capabilities for their Molly autoinjectors.

Medicine 40

Medicine Drug Delivery Manufacturing Marketing 40

The Pharma Data

DECEMBER 17, 2020

Ten Western states reported a more than 98% increase in synthetic opioid-involved deaths, the researchers said. Based upon earlier research, these deaths are likely linked to co-use or contamination of cocaine with illicitly manufactured fentanyl or heroin. In 18 of these jurisdictions, the increase was greater than 50%.

Drugs 52

Drugs Contamination Scientist Manufacturing 52

XTalks

OCTOBER 21, 2022

A contamination at a retail establishment has the potential to greatly impact public health. Related: What Does the FDA Registration Renewal Process Entail for Food Manufacturers? Not long into the pandemic, it became increasingly important to explore ways to overcome these challenges.

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Regulation Contamination Manufacturing Development 52