BioPharma Reporter

OCTOBER 6, 2021

A probe has identified 'human errorâ at the Spanish contract development and manufacturing organization, Rovi, as the reason for the presence of metal contaminants in Moderna COVID-19 vaccine doses, leading to Japanese authorities withdrawing 1.6 million doses of the shot in August.

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Contamination Vaccination Vaccine Manufacturing 64

Pharmaceutical Technology

JANUARY 6, 2023

The preparation of a semi-solid dosage form – from formulation and development, to scale-up, commercial manufacturing, and packaging – should ideally take place under one roof in a contiguous, end-to-end workflow to avoid unnecessary equipment and process changes. Simplicity matters. Optimising development and scale-up.

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Production Manufacturing Development Bioequivalency 130

XTalks

AUGUST 11, 2023

Related: 3 New Additions to the Plant-Based Cream Cheese Market As part of the brand’s “The Snack Your Snacks Would Snack on If Snacks Could Snack on Snacks” marketing campaign, Sabra released two YouTube Shorts that capture the appeal of Sabra Buffalo Hummus made with Frank’s RedHot and Sabra BBQ Hummus inspired by Stubb’s.

Marketing 96

Marketing Branding Production Sales 96

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.

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Contamination Compliance Regulation Production 105

XTalks

NOVEMBER 23, 2023

Salmonella Outbreak from Poultry — The US A widespread Salmonella outbreak linked to contaminated poultry affected thousands across multiple states this year. It also encouraged a citizen petition to make it illegal to sell poultry contaminated with any one of 31 strains of Salmonella. Coli Daycare Outbreak — Canada In September, an E.

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Contamination Regulation Bacterium Allergies 103

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. What is driving the surge in demand for APIs?

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Containment Manufacturing Production Contract Manufacturing 130

pharmaphorum

NOVEMBER 24, 2022

Now, this service-centred model is delivering advantages in the pharmaceutical industry, with costly manufacturing facilities and processes becoming widely available on an on-demand basis. µm per cubic metre – with ISO 9 representing the least stringent measures, while still being significantly cleaner than typical manufacturing facilities.

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Manufacturing Pharma Packaging Production Packaging 98

Pharmaceutical Technology

NOVEMBER 17, 2022

According to GlobalData analysis, specialist small molecule API capabilities such as containment or controlled substances are driving large contract manufacturing organisations (CMOs) to acquire facilities.

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Containment Contamination Contract 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.

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Contamination Manufacturing Regulation Production 130

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.

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Regulation Contamination Manufacturing Production 130

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.

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Packaging Packaging Production Contamination 130

XTalks

MARCH 26, 2021

The act will set maximum levels of mercury, lead, inorganic arsenic and cadmium in baby food and cereal, and require manufacturers to comply within one year. The reaction from parents was swift and class action lawsuits were filed against various manufacturers, including Beech-Nut, Gerber and Campbell.

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Regulation Manufacturing Contamination Production 98

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. The ingredients used in these drugs are high potency, even at small doses, and pose a risk to both human health and cross-contamination with other drugs in a manufacturing environment.

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Manufacturing Production Containment Contamination 130

XTalks

AUGUST 10, 2020

This phase-out comes after an FDA post-market scientific review and analysis from studies found bio-persistence of the grease-proofing substances. 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.

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Packaging Packaging Contamination Containment 98

XTalks

OCTOBER 26, 2020

Manufacturing packaging often pollutes the air with greenhouse gases, heavy metals and particulates and produces wastewater that contains potentially toxic contaminants. First, by fulfilling social corporate responsibility, companies can ensure that their products and overall brand are better received by their target market.

Packaging 98

Packaging Packaging Marketing Containment 98

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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Manufacturing Production Contract Manufacturing Contamination 40

XTalks

MAY 30, 2023

The healthcare industry has one of the heaviest environmental footprints, and manufacturers are increasingly faced with regulations to make more sustainable products,” said Mohammad H. Unfortunately, about 91 percent of this plastic waste from healthcare is not recycled and either ends up in landfills or contaminates natural environments.

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Drug Delivery Drug Delivery Systems Manufacturing Contamination 98

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. Containment challenges and opportunities High containment facilities guard against exposure to extremely potent products and cross-contamination.

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Containment Manufacturing Contract Manufacturing Bioavailability 130

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.

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Packaging Packaging Vaccination Vaccine 130

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.

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Manufacturing Production Contamination Medicine 40

Pharma in Brief

AUGUST 9, 2021

The proposed amendments are intended to modernize the Canadian therapeutic product regulatory system at every stage of products’ lifecycles from authorization to post-market. Terms and conditions would be imposed after discussions with the manufacturer and would obligate them to take steps to manage risks and resolve uncertainties.

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Regulation Drugs Manufacturing Production 98

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 This event is CPD Accredited.

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Compliance Contamination Manufacturing Production 52

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

Pharmaceutical Technology

MAY 11, 2008

This process might be expensive to implement with the outlay for new precision equipment but solves the per-item marking problem for the US market. ” LEVEL TRACKING Pharmaceutical manufacturing company Seidenader Vision has also developed a system – the SATrack and Trace. .

Drugs 100

Drugs Packaging Packaging Production 100

Roots Analysis

FEBRUARY 28, 2022

Considering patient’s health and safety, the drug products are expected to be free from microbial contamination and should be safe for use throughout the drug’s life cycle. It also ensures that the quality of drug product is maintained from the point of manufacturing to its use.

Containment 52

Containment Packaging Packaging Contamination 52

Delveinsight

SEPTEMBER 8, 2021

A group of experts specialized in the field of pharmacology deals with clinical/non-clinical testing, biologic design and manufacturing, regulatory agency interactions, submission preparation, and so on. Market Assessment & Operational Sales. A new product shall open to an entirely new market.

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Marketing Production Sales Life Science 52

XTalks

AUGUST 26, 2024

Lead, a toxic metal, can enter the food supply through environmental contamination during the growing, raising or processing of foods. In this episode of the Xtalks Food Podcast, Sydney talks about how lead contamination in food can arise and what the FDA is doing to monitor lead levels. per share in an all-cash transaction.

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Contamination Branding Compliance Regulation 52

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.

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Containment Development Drugs Contract Manufacturing 130

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. Upgrading facilities. However, we understand that this is not always possible. Implementing Pharmaceutical Quality systems.

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Compliance Regulation Manufacturing Contamination 98

XTalks

FEBRUARY 5, 2021

Packaging ensures that food products maintain freshness throughout their shelf lives and do not prematurely spoil or become contaminated. Barrier Protection from Oxygen, Water Vapor and Contaminants. Product branding and advertising is more important than ever, with the market for food products becoming increasingly competitive.

Packaging 64

Packaging Packaging Contamination Containment 64

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

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

XTalks

JULY 22, 2021

Related: Johnson & Johnson Pulls Neutrogena and Aveeno Spray Sunscreens Over Benzene Contamination. Chantix has a safety profile that has been established over 15 years of marketing authorization and through a robust clinical program, according to the FDA. Pfizer said the benefit/risk profile of Chantix remains positive.

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Drugs Doctor Doctors Branding 98

Pharmaceutical Technology

MARCH 6, 2023

Proper monitoring and control methods help manufacturers carry out the freeze drying, or lyophilisation, process correctly and consistently. There are two main parameters to control, says Daniel Kuchenbecker, Market Manager, Medical & Pharma, Pfeiffer Vacuum. Please check your email to download the Webinar.

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Production Contamination Manufacturing Marketing 130

pharmaphorum

JANUARY 24, 2022

The Global High Potency API/HPAPI Market is projected to reach 37 billion USD by 2027, growing at an ever-increasing CAGR of 8.43%. Explore the employment of cleaning validation, organisational controls, and facility as key measure to tackle cross contamination. Highly Potent Active Pharmaceutical Ingredients. 9th and 10th May 2022.

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Containment Engineer Contamination Manufacturing 52

Roots Analysis

JUNE 6, 2024

Roots Analysis added The autoinjectors market research report forecast period from 2024 to 2035. The autoinjectors market is highly fragmented, featuring the presence of both established companies as well as emerging start-ups. Key Initiatives in the Autoinjectors Market Domain A.

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Medicine Drug Delivery Manufacturing Marketing 40