Roots Analysis

AUGUST 8, 2023

Recently, in the biopharmaceutical industry an increasing demand for quality biologics has been observed, where Single-Use-Systems (SUSs) Bioreactors have emerged as one of the most prominent and reliable solution for biomanufacturing. What is Single-use Bioreactors?

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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.

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Vaccines 40

European Pharmaceutical Review

JANUARY 22, 2024

The report shared that due to the key role of these services for single-use systems and finished formulations, many analytical techniques, “including UPLC, HPLC, Q-TOF, FTIR, accelerated solvent extraction, and GC-TEA, are used for extractable analysis”. Between 2023 to 2030, this represents a CAGR of 15.13

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Vaccines 52

Roots Analysis

APRIL 19, 2022

Bioprocess technology is one of the integral parts of biotechnology that deals with different biological processes involving living or competent cells to get value added products at the end of the process. Single-use technology involves the use of single-use systems, which are disposable in nature and can be used only once.

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BioPharm

MAY 30, 2023

Although new single-use technologies offer the flexibility needed to overcome several challenges in ATMP production, there are many considerations and hurdles manufacturers must be aware of when scaling.

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BioPharm

MAY 4, 2023

This guide explains how biopharmaceutical production and bioprocessing trends demand flexibility and consistency in R&D, scale-up, and production processes, requiring optimization through analytics.

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BioPharm

OCTOBER 19, 2022

Speed-to-market, flexibility and process efficiency are more important than ever in biopharmaceutical production. And so is the importance of single-use systems. Lorenzo De Benedictis provides insights and outlook on the future of single-use systems in Biopharma. And yet there is hesitation.Dr.

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BioPharm

OCTOBER 19, 2022

Speed-to-market, flexibility and process efficiency are more important than ever in biopharmaceutical production. And so is the importance of single-use systems. Lorenzo De Benedictis provides insights and outlook on the future of single-use systems in Biopharma. And yet there is hesitation.Dr.

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ISPE

DECEMBER 13, 2022

Advancements & Innovations in Decontamination and Single-Use Technology. Advancements & Innovations in Decontamination and Single-Use Technology. What should be considered when deciding between restrictive access barrier systems (RABS) and isolators to protect the product? Trudy Patterson. Tue, 12/13/2022 - 14:47.

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Dosage FDA 52

Hospital Pharmacy Europe

MARCH 21, 2024

1 This manufacturing technology is becoming increasingly important in all production sectors after having been first commercialised in the mid-1980s. Since then, several different methods of 3D printing have been developed, and many of these are now used for pharmaceutical purposes. 4 This technology is not the easiest to use.

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Hospitals Compounding Dosage FDA 111

European Pharmaceutical Review

JANUARY 25, 2024

Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. Ophthalmic drug products should be evaluated for extractables and leachables, FDA asserted.

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FDA Documentation Method Validation Packaging 91

European Pharmaceutical Review

SEPTEMBER 20, 2023

In recent years, the pharmaceutical industry has undergone a remarkable revolution, ushering in new and innovative products to address a wide range of unmet medical needs. This is the point at which mass spectrometry (MS) can be leveraged to accelerate and de-risk product and process development. Where now with quality by design?

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STAT

OCTOBER 20, 2023

Today, the criteria used to assess the clinical value of new pharmaceuticals and medical devices varies widely across Europe, making it more challenging for biopharma companies to efficiently launch products in multiple countries and contributing to the disparities in access across the continent.

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The FDA Law Blog

JANUARY 15, 2024

This story goes back to the 2009 Family Smoking Prevention and Tobacco Control Act, which prohibits manufacturers from selling any “new tobacco product” without authorization from FDA. FDA said randomized clinical trials could be used, but so could observational studies with respect to cessation data.

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FDA Documentation 115

European Pharmaceutical Review

APRIL 24, 2024

Sterile tryptone soya agar 55mm diameter tryptone soya agar RODAC contact plates were used in the investigation. stated that they aimed to determine “a convenient manual sampling procedure that can be routinely used to provide more consistency of practice”. Eaton et al. Eaton et al. However, Eaton et al.

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European Pharmaceutical Review

APRIL 10, 2024

The recent FDA approvals of two microbiome products in the US, in November 2022 and April 2023, 1-2 represent a significant milestone, maturing the industry and paving the way for advancement and regulatory clearance of additional microbiome products in broader indications.

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Immunization Chemotherapy FDA Pharmaceutical Companies 86

European Pharmaceutical Review

JANUARY 16, 2023

This Q&A covers the key developments in pharmaceutical microbiology in 2022, featuring insight from pharmaceutical microbiology experts: Dr Tim Sandle, Head of Microbiology, Bio Products Laboratory Limited. Dr Tony Cundell, PhD, Principal Consultant, Microbiological Consulting, LLC. Miriam Guest, Principal Microbiologist at AstraZeneca.

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Vaccines FDA Research Laboratories Documentation 127

European Pharmaceutical Review

FEBRUARY 12, 2024

But scaling up production and ensuring global supply of sensitive biological pharmaceuticals is a remarkable process that embodies Industry 4.0 – the rapid technological advancement that is characterising the fourth industrial revolution – and the very latest in advanced manufacturing technologies.

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Process Improvement Packaging 92

Pharmaceutical Technology

MARCH 22, 2023

The pharmaceutical industry began using radio frequency identification (RFID) tags in the early 2000s. Pfizer was the first to use the tech, adding RFID tags to track a Viagra (sildenafil) shipment circa 2006. As computing has developed in the past decade, so has the potential to store and use information in the cloud.

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Labelling Data Entry Communication FDA 105

Pharma Marketing Network

OCTOBER 13, 2023

Multichannel marketing is an effective digital strategy for pharmaceutical companies to reach consumers and encourage them to purchase products. Defining Multichannel Marketing Multichannel marketing is the practice of using multiple channels to communicate with customers and promote products or services.

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Pharmaceutical Companies Pharmaceutical Companies Communication 98

The Checkup by Singlecare

FEBRUARY 16, 2024

Instead, if you have an asthma-related cough, you’ll want to use your rescue inhaler, such as albuterol or levalbuterol. There are also other medications that can be used for long-term control of asthma symptoms, including cough. Some people use a spacer (valved holding chamber) with an MDI.

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Labelling Insurance Coverage FDA Insurance 75

Digital Pharmacist

DECEMBER 20, 2023

By shifting your focus, you can meet your patient base on the devices and platforms they use every day, establish an online presence, and market yourself on multiple channels. For example, this could be cost, convenience, location, or specialty products and services. How Can Pharmacies Attract Customers?

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The Checkup by Singlecare

APRIL 19, 2024

Whether you have an underlying condition that intensifies during periods of excess stress or your pain is caused by a single, stressful event, abdominal distress is no picnic. Peppermint Peppermint is often used to flavor toothpaste, gum, and tea. It soothes the stomach by increasing mucus production in the inner layer of the stomach.

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European Pharmaceutical Review

NOVEMBER 24, 2022

The number of unauthorised and unregulated online outlets selling counterfeit pharmaceutical products is continuously growing, with many selling counterfeit medications via the internet typically posing as legitimate vendors. One area in which the problem can be tackled effectively is product packaging.

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Packaging Labelling Documentation Dosage 101

The Checkup by Singlecare

DECEMBER 13, 2023

It can be used in adults and children to relieve symptoms of pain (such as from a sore throat or headache) and lower fever. When taking a combination product like this, you have to ensure that each ingredient is safe for you to take. certain migraine medications and combination cough and cold products).

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Dosage Packaging Labelling Hospitals 98

European Pharmaceutical Review

AUGUST 31, 2023

Even with extremely rapid vaccine development, limitations in production capabilities can have real-life implications. To cope with the growing demand for production flexibility and agility, IMA Group is structured according to highly specialised pharmaceutical divisions that concentrate on specific processing and packaging areas.

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Hospital Pharmacy Europe

SEPTEMBER 4, 2023

The use of a stem cell gene therapy in sickle cell disease may offer a promising, curative treatment, according to a new study published in the New England Journal of Medicine. The overall effect of this transcriptional switch is a move away from production of foetal haemoglobin to adult haemoglobin within red blood cells.

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Hospitals 95

European Pharmaceutical Review

DECEMBER 26, 2023

The increasing adoption of technologies promoting safety, efficacy and reduced production costs has been a persistent trend that will continue to benefit the industry and help to treat a broader patient population. million for Hemgenix [AAV5-hFIX-Padua]). This enhances the commercial viability of USP.

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Packaging Vaccines 88

The Checkup by Singlecare

FEBRUARY 2, 2024

Here are some common reasons people use chlorophyll: To fight acne : Some research has found that chlorophyll can help fight acne. One small, short-term study of about 10 people found that using a topical gel or ointment containing chlorophyllin helped clear up acne and minimized the appearance of large pores.

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ISPE

NOVEMBER 29, 2022

The rapid introduction of a pandemic vaccine created a challenge to the classical sequential approach to process characterization, transfer, and validation at production scale. Use of NTT (No-Touch-Transfer) with fully automatic bag opening for inner and outer bag. Given the expense of each unit, lost product must be minimized.

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ISPE

APRIL 28, 2023

More than ever before, biotechnology companies are pushing for exponential growth by expediting the scalability of manufacturing processes and the use of different modalities. Reducing the time it takes to move through these stages can help companies gain a competitive advantage by being the first to market with a new product.

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Pharmaceutical Technology

FEBRUARY 28, 2023

Breakthroughs in therapies containing monoclonal antibodies (mAbs) are showing ever-greater potential in treating a range of diseases, alongside biopharma manufacturers facing the challenge of keeping up with demand for production while controlling costs. Increasing product yield is the most fundamental way to achieve this.

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Documentation Communication 94

The FDA Law Blog

DECEMBER 22, 2022

One of the more concerning provisions in the Appropriations Bill can be found in section 3306, which addresses “Bans of Devices for One or More Intended Uses.” The Court agreed with the Petitioners, holding that banning the use of the device would regulate the practice of medicine or prohibit the off-label use of a device.

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ISPE

AUGUST 9, 2023

This article discusses the considerations and approaches adopted by Pfizer, Eli Lilly, GSK, and Amgen in designing and implementing their small molecule drug substance (DS) CM processes and some key contrasts relative to existing CM approached for drug product (DP). In DS production, numerous and diverse sets of unit operations (e.g.,

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Compounding 98

ISPE

AUGUST 30, 2023

WuXi Biologics built one of the largest contract manufacturing facilities in the world using single-use production technology. The final 13 months of construction (about 3,000,000 hours of work) were completed without a single recordable event. recordable injury rate (TRIR).

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Pharmaceutical Companies Pharmaceutical Companies 98

Pharmaceutical Technology

MAY 16, 2023

The US Food and Drug Administration (FDA) has approved expanded labelling for Cumberland Pharmaceuticals’ Caldolor therapy to include use in infants. All but one patient in the trial received a single dose of Caldolor. Cumberland sponsored a multi-centre trial in 21 hospitalised infants in order to validate its expanded usage.

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Labelling FDA 98

Pharmaceutical Technology

MARCH 17, 2023

As the field of digital therapeutics continues to broaden, specific uses in mental health and neurology are increasingly making headway for patients and on the market. Companies are testing the use of digital platforms along with pharmacological treatments.

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Packaging Patient Care FDA 111