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A new Denmark-based manufacturing facility is set to establish the final development steps and upscaling of cell therapies. Partly due to this and due to the explorative phase cell therapy is in, it is very expensive to develop and manufacture cell therapies, so there simply are not many facilities doing it.”
Drastic steps need to be taken if the UK is to reverse a steep decline in medicines manufacturing in recent years, according to a cross-industry coalition. Over the same period, similar countries – including Ireland, France, and Germany – have been moving to boosting manufacturing productivity, output, and exports.
Our ambition is to build a modern, industry-leadingmanufacturingnetwork, by bringing together talented people and cutting-edge processes, technologies and data to reliably deliver high quality, affordable and sustainable medicines and vaccines to patients. Standardise manufacturing .
Sandoz has announced it is investing €25 million in its manufacturing site in Holzkirchen, Germany, to expand its biosimilar development capabilities. The investment “strengthens Bavaria’s position as a leading biotechnology hub” and will help to generate “innovation and job growth” noted Bavarian Prime Minister Dr Markus Söder.
AstraZeneca has announced a $300 million investment in a US-based manufacturing facility in Rockville, Maryland, which will focus initially on T-cell therapies for oncology indications. Currently, AstraZeneca’s manufacturing sites in the US focus on producing small molecules and biologics, the company highlighted.
After agreeing to acquire a US-based manufacturing facility and its operations from Novartis, Bristol Myers Squibb (BMS) adds in-house production of viral vectors to its capabilities. This move will support the expansion of the company’s global cell therapy manufacturingnetwork.
WHO confirmed that the newly approved WLAs include: The European Medicines Regulatory Network (EMRN), which is made up of the European Commission (EC), the European Medicines Agency (EMA) and the medicines regulatory authorities of 30 countries.
September 2023 saw a wave of new pharmaceutical manufacturing facility expansions and launches across Europe. Importantly, each site features advanced technologies to support development and manufacture of these therapeutics. Materials and financing costs are high and squeezing manufacturers and their customers alike.
There has been a steady stream of developments in the vaccine manufacturing space throughout 2023. A notable milestone was Moderna’s announcement in April that it had, following finalisation of a ten-year strategic partnership with the UK Government, commenced construction of its mRNA vaccine manufacturing technology centre.
You’re here because you want more manufacturing sales leads—and you’re not alone. Recent research shows that 63% of manufacturers consider marketing a “high priority” It makes sense: good marketing produces quality leads, who can then be sold to by sales teams. Let’s get started!
Conducted last month, survey respondents expect that tariffs will bring: A significant number of biotechs (94 percent) anticipate a surge in manufacturing costs if tariffs are put in place on import trade from the EU, thereby decreasing access to affordable medicines.
a groundbreaking respiratory support technology company, announced today that it has begun the manufacturing process for the ALICE CPB (Cardiopulmonary Bypass) device (the “ALICE device”) to undergo the Verification and Validation phase prior to its planned 2023 submission to the U.S. Inspira Technologies OXY B.H.N. and Israel.
Maja Pedersen has been appointed as Chief Quality Officer (CQO), to lead FUJIFILM Diosynth Biotechnologies’ global quality team. There, she oversaw the entire CDMO network. Pedersen’s new role is effective immediately. Commenting on her new appointment, Pedersen said that she is “excited” about engaging with relevant stakeholders.
Discover the leading patient adherence pharmaceutical companies. Many companies use artificial intelligence (AI) to enable pharmaceutical manufacturers to overcome barriers to medication adherence. The post Leading patient adherence pharmaceutical companies appeared first on Pharmaceutical Technology.
By remaining compliant, medicines are manufactured in line with their pre-defined and approved specifications, in order to ensure the delivery of safe and effective products to consumers. So, with mandates in place, how do manufacturing facilities meet these compliance goals? The dominion of data. Cybersecurity and non-conformance.
Sandoz] has the only major remaining vertically-integrated production network for penicillins in Europe” Penicillins are the leading category of antibiotics worldwide, Sandoz highlighted. This represents a significant upgrade of penicillin active pharmaceutical ingredient (API) manufacturing, Sandoz declared.
The pharmaceutical supply chain is a global and complex network that includes a wide range of stakeholders such as pharmaceutical manufacturers, wholesale distributors, and pharmacy benefit managers (PBM), to ensure efficient and timely delivery of medications to the patients.
Under the terms of the agreement, BioNTech will pay $50 million to Autolus, granting the immunotherapy company rights including the option to access Autolus’ commercial and clinical site network, manufacturing capacities in the UK and commercial supply infrastructure.
Specifically, an additional four years of funding for the Advanced Therapy Treatment Centre (ATTC) Network is available through the programme. The funding will start with three established Centres, and then across an expanded network, according to Chief Clinical Officer for Cell and Gene Therapy Catapult, Jacqueline Barry.
A report from the Advanced Therapies Treatment Centre (ATTC) Network has highlighted urgent need for rapid change and improvement in the field to maximise patient access to advanced therapies. It was compiled based on expertise gathered at the ATTC Network’s UK Advanced Therapies Adoption Challenge event in October.
The exhibition, which will take place from 8-10 October 2024, is being hosted in Milan for the second time in three years in recognition of the massive pharmaceutical ingredients and manufacturing industry in the region. “We expect a large international attendance and will marry this with local and regional manufacturing insights.”
Sales reps in the manufacturing industry face unique challenges. A strong manufacturing sales training program can help. In this article, we’ll explain what manufacturing sales training is, why it’s important, how to build an effective manufacturing sales training program for your department, and more.
To be a superpower globally, the UK life sciences sector must not only discover and develop medicines of the future domestically, but also manufacture a significant share in the country too, according to a new report from the Medicines Manufacturing Industry Partnership (MMIP). It provides almost 45 percent of the £36.9
Sandoz , a leading antibiotics producer has announced its €50 million investment to increase Europe’s manufacturing capacity of finished dosage form (FDF) penicillin, the most common form of antibiotic worldwide, to enhance global manufacturing capacity of amoxicillin and other major penicillin products.
The pandemic highlighted how fragile the global manufacturingnetwork is, as supply of certain products was limited and regulatory inspections became difficult to carry out. In a global economy, across a number of industries, low-margin products are often manufactured in countries where labour is cheap.
For companies that manufacture globally marketed products, the journey towards implementing rFC is a slow one” There are two possibilities for rFC implementation, depending on the pharmacopeial guidance. However, for companies that manufacture globally marketed products, the journey towards implementing rFC is a slow one.
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. Environmental Monitoring In-Depth Focus 2024 How is eXmoor navigating these advances in the sector? What were the solution?
tariffstargeting imports from key manufacturing hubs like China, Mexico, and Canadais set to introduce new challenges that will reshape the landscape of medical device sales and manufacturing in 2025. based manufacturers relying on imported parts. A core objective of these tariffs is to bring more manufacturing back to the U.S.,
Two of ZS’ major studies suggest that the trend towards more advanced KAM strategies and capabilities will continue to accelerate for pharma manufacturers. How should leading pharma companies respond? Consolidation among providers continues unabated, leading to larger and larger health systems. healthcare ecosystem.
Thankfully, in this post , I already addressed the key elements for a successful manufacturer/distributor relationship (If you haven’t seen it, you will find it very useful when you refer to it). Moreover, I have seen 5 pitfalls in the manufacturer/distributor relationship that could endanger the partnership. Open feedback.
Within the 14-page document , published by an EMA special task force, are 10 recommendations of best practices that “marketing authorisation holders, wholesalers, distributors, and manufacturers can consider adopting to ensure continuity of medicinal product supply and reduce the impact of shortages”.
Enhancing Development and Manufacturing Operations through Environmentally Sustainable Means The pharmaceutical industry’s evolving nature impacts patient care due to ongoing drug shortages from weakened operations. This not only boosts sustainability but also enhances process efficiency, leading to lower manufacturing costs and risks.
Pharmaceutical benefit managers and management companies serve as intermediaries between insurance companies, pharmacies, and drug manufacturers. Pharmaceutical Technology has listed some of the leading benefit managers and management companies in the industry based on its intel, insights, and decades-long experience in the sector.
Pharmaceutical drug research and development (R&D) activities are capital-intensive, which makes the outsourcing of clinical dose manufacturing and marketing popular. Find the leading clinical dose companies in contract marketing.
For hundreds of years, we have found myriad uses for microbial enzymes in manufacturing – from food, drink, and household products to a range of industrial applications. The enzymes must be manufactured under cGMP conditions – completely free of animal-derived ingredients.”. Developing best-in-class speciality enzymes.
Manufacturing delays and capacity issues that continue to impact the pharmaceutical supply chain have led to medicine shortages around the globe; an issue that has been exacerbated further by geopolitical events, the energy crisis and rising inflation. What are the top three supply-related challenges facing pharmaceutical manufacturers?
This major difference leads to very different requirements and processes for the clinical trial supply chain, which are summarized below. CGT trials operate with much lower volumes of manufactured final product. CGT have highly unique and specialized manufacturing processes. Differences in CGT vs traditional trials supply chain.
The alliance will focus on measures to expedite the clinical programme of NKGen using its autologous NK cell therapy, SNK01, and leveraging its clinical partners and donors’ network. Based in the US, NKGen develops and markets new autologous, allogeneic and CAR-NK NK cell therapies.
The collaboration combines the virtual executive leadership and programme management of Cell One Partners with the technologies, capabilities, and capacity of CBM for the development, testing, and manufacturing of therapies.
Trauma/ER: The BodyTom 64’s unique combination of internal lead shielding and battery operation allows any standard trauma bay to be transformed into an advanced CT imaging suite. NeuroLogica is the global corporate headquarters and manufacturer of mobile computed tomography devices. About NeuroLogica. NeuroLogica Corp.,
Overcoming challenges in patient safety, manufacturing and supply of radiopharmaceuticals As clinical trials progress and the first results are published, companies’ best candidates will emerge in the next five years. Long production times and high energy costs in manufacturing are additional considerations.
Energy crisis effects will be felt across healthcare, but for medicines manufacturing and delivery the issue is especially complex because the networks of medicine supply extend across the globe and across countries which see differing impacts of energy costs and supply. Medicines manufacturing is energy intensive.
This creates a need for flexible and scalable software tools for data processing, according to Robin Schmid from Institute of Organic Chemistry and Biochemistry of the Czech Academy of Sciences (IOCB Prague) and UC San Diego (CA, USA), project lead architect and one of the first authors of the paper.
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