This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
This poses a significant challenge for pharmaceuticalmanufacturers, not least because of the technical challenges related to operations, supply chain and the environment. This article explores the potential impact of the proposal and considers how manufacturers can ensure the safety and reliability of their products.
The Fourier PAT includes a Fourier 80 compact NMR analyser equipped with a synTQ NMR dadpter that enables the integration with synTQ PAT knowledge management software. This can lead to refined (bio)pharmaceuticalmanufacturing operations that propel product quality, operational efficiency and overall productivity to new heights.
The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceuticalmanufacturing site quality rating system, the Quality management maturity (QMM) programme.
Discover the leading patient adherence pharmaceutical companies. Pharmaceutical Technology has listed the top patient adherence pharmaceutical companies based on our intel, insights and decades-long expertise in the sector.
Pharmaceutical wholesalers act as intermediaries between pharmaceuticalmanufacturers and retailers and facilitate the delivery of the right medicines in a timely, efficient, and secure manner. Discover the top pharmaceutical wholesalers. Services, such as customer relationship management (CRM), and after-sales service.
Pharmaceutical Technology has listed the leading API chemical companies in contract marketing based on its intel, insights, and decades of experience in the sector. The post Leading API chemical companies in contract marketing appeared first on Pharmaceutical Technology.
True adherence cannot exist without total health management, and how we manage it matters. Simplification In an increasingly complex healthcare system, it’s very easy to over-engineer a single aspect of health when in reality, what we need is a simplification of how we manage all aspects of our health. So how is this achieved?
Commercial dose companies form a critical component of the pharmaceuticalmanufacturing 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.
Pharmaceutical Technology has listed the leading commercial dose non-sterile companies in contract marketing based on its intel, insights, and decades of experience in the sector. The post Leading commercial dose (non-sterile) companies in contract marketing appeared first on Pharmaceutical Technology.
However, with cleanrooms-on-demand representing a feasible and accessible opportunity for those across pharmaceuticalmanufacturing, what are the key challenges in adoption and how can we expect the industry to overcome them to reap the rewards on offer? But with a single dedicated cleanroom environment costing around $2.5
Component management is fairly new to the regulatory market, with pharmaceutical firms moving from traditional document management systems to more dynamic component content management systems. Aside from the increasing volumes of data, submission teams have other reasons for moving to component management.
Andreas Häner (AH): Roche, along with other pharmaceutical companies, acknowledges concerns about pharmaceuticals in the environment (PiE). These professionals also support sustainability by promoting responsible effluent management practices that go beyond compliance.
Pharmaceutical Technology has listed some of the leading contract commercial packaging companies, based on its intel, insights and decades-long experience in the sector. The post Leading commercial packaging companies in contract marketing appeared first on Pharmaceutical Technology.
Consequently, pharmaceuticalmanufacturers risk their reputation if impersonating products fail to deliver the expected quality or health impact. For manufacturers, this allows for greater protection of products courtesy of real-time tracking data and the ability to refine and secure supply chains by spotting weak links.
The most prominent among them include: AI misinterpretation of critical information: As an example, a team might ask ChatGPT to answer a question, and the AI engine may deliver an impressive volume of information, while misaligning with the core business, leading to conclusions that are either overvalued or flat-out wrong.
The CDSCO headquarters conduct regulatory supervision over drug importation, approval of new pharmaceuticals and clinical trials, meetings of the Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB), and approval of some licences as the Central Licence Approving Authority.
Combination Therapy in Oncology Combination therapies comprising two or more therapeutic agents have become a cornerstone of oncology management and are increasingly a development focus for the pharmaceutical industry. When 1+1 ≠ 2 In theory, combining two or more branded agents can lead to a price that exceeds SoC monotherapy.
When questioned about which technologies he considered have potential to advance the sector, Chornet emphasised that not only is mRNA as a vaccine technology “a very promising and interesting platform [but that it is] disruptive and a game changer technology for vaccine [manufacturing] and overall biotech.”
AI can be used to improve the efficiency of pharmaceuticalmanufacturing processes through ongoing monitoring and predictive maintenance of equipment, optimization of production processes, and automated quality control, helping to reduce costs and improve yield.
How companies can both leverage AI and maintain essential human intervention for operational excellence—through optimal data management and comprehension, workforce education, and subsequent technological transformation. Humans are responsible for the data, including setting up data management systems that empower AI.
The discovery of a new chemical entity (NCE) that could potentially lead the way to a ground-breaking therapeutic treatment is an exciting prospect for any chemist. If clinical trials prove successful, that same process should then be scaled to commercial manufacturing.
Marcello Cattani, country lead and president and managing director, Italy & Malta, at Sanofi, as well as president of Farmindustria, spoke next, expressing that he couldn’t have been happier to be in attendance for the occasion. Going beyond the standards of care; improving drug safety and efficacy.
The status isn’t awarded lightly and Chiesi is the largest pharmaceuticalmanufacturer to be named a B Corp. “We We start our meetings by bringing to life a patient testimony and asking the team to reflect on how the goal of each meeting ultimately leads back to the needs of patients,” Chiesi says. “If About the author.
Nitrosamines have garnered significant attention from the pharmaceutical industry due to their detection in commonly prescribed medications for conditions like type 2 diabetes, high blood pressure, and heartburn. [1] Regulatory manager at a fortune 500 company Implications for stakeholders: As regulations evolve, so must the industry.
Cancer detection involves measurement of biomarkers, which leads to the application of targeted therapy (which targets specific cancer cells). In Germany, medicine approval by the European Medicines Agency (EMA) leads to reimbursement of the medicine by statutory health insurance, with free pricing in the first year.
The introduction of rapid microbiological testing methods, such as biofluorescent particle counters for real time detection of microbial contamination, has had an important impact on cell and gene therapy manufacturing. This is the first step towards the use of IoT technologies to enhance the management and maintenance of our cleanrooms.
Additionally, regulatory compliance is simplified, and extensive EH&S management systems are not as readily needed due to the absence of solvents from the process. Pharmaceutical companies can produce high-quality ASDs with improved sustainability, scalability, and performance by adopting these advanced fusion-based technologies.
Tablet manufacturing, which is the most common OSD form, takes an API dry powder ingredient and compresses it to form tablets, which can be coated or uncoated. Compared to other dosage forms, tablets are simpler to manufacture, package, and transport.
The inventory position of 28 major pharmaceuticalmanufacturers in 2022 has been revealed in an annual report. Analysis explored the impact of macro-trends on inventory management from corporate reports of Big Pharma companies including Merck, AstraZeneca and Pfizer.
Although the driving factors of the shortage are complex, the bottom line is that drug manufacturers, particularly those that produce generic drugs, can’t afford to stockpile raw materials and products to prepare for shortages due to financial, storage capability, and product expiry limitations.
While navigating changes has long been a challenge for the industry, the last two years’ events have made supply chain management significantly more difficult. Come back next week for the final part, on managing workforce shortages. About the Author. Maxine Fritz, executive vice president, Pharma Biotech, NSF.
Historically, pharmaceuticalmanufacturers have built sufficient capacity so that they can leverage sudden surges in demand. What do you consider are the challenges with managing data? Some of the primary packaging material has enormous lead times so we’re having to stock up on inventory.
For instance, in pharmaceuticalmanufacturing, mistakes in training can lead to contamination or waste, which can cause businesses unnecessary headaches. Lynne Byers, global managing director, Pharmaceuticals and Dietary Supplements Consulting, NSF. About the Author.
GoodRx also offers supportive resources to help consumers holistically manage their condition, including discounts on continuous glucose monitors (CGMs) and coupons for diabetes medications, as well as a Diabetes Hub that offers diabetes-specific articles and resources written by medical experts on GoodRx Health. “We References: 1.
The pharmaceutical freeze-drying systems market is expected to be driven by the integration of smarter technologies in lyophilisation methods such as electron microscopy, biochemistry, and advancement in surgeries.
Despite this toll, AMR has often been called the ‘silent pandemic’: 4 “AMR is sadly silent because it has not been discussed like other pandemics – and of course has been in the shadow of the COVID-19 pandemic in recent years,” commented Melissa Gong Mitchell, Secretariat Lead of the AMR Industry Alliance.
The pharmaceutical supply chain is a global and complex network that includes a wide range of stakeholders such as pharmaceuticalmanufacturers, wholesale distributors, and pharmacy benefit managers (PBM), to ensure efficient and timely delivery of medications to the patients.
What are the top three supply-related challenges facing pharmaceuticalmanufacturers? Manufacturers must navigate this complex landscape, obtain necessary certifications, and stay updated with evolving regulations. Globalisation and supply chain complexity are a factor.
In an age of disruption, technology is key to enabling pharmaceuticalmanufacturers monitor, track and control shipments and their processes. Pharmaceutical firms are changing the way they do business; the future winners will be highly automated and digitalised. But this results in huge, complex datasets.
AstraZeneca has successfully leveraged the work of this CPI collaboration to define our Autonomous Manufacturing strategy, which has supported our vision of implementing industry-leadingpharmaceuticalmanufacturing and accelerated the development of our future ready IT architecture, shared Francis ODoherty, Director, Operations IT at AstraZeneca.
Implementing PAT in (bio)pharmaceuticalmanufacturing New sensors or larger equipment with more complex setups (software and hardware) require stringent procedures to become fully implemented in a good manufacturing practice (GMP) manufacturing facility.
We organize all of the trending information in your field so you don't have to. Join 8,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content