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The first industrial-scale pharmaceutical manufacturing facility for production of lead-212-based radioligand therapies has been inaugurated. This news follows the company beginning construction on a similar facility in France , which is set to produce lead-212 radioligand therapies for the European market.
Orano Med (a subsidiary of the Orano Group), has begun to build a new manufacturing site for targeted alpha therapies (TAT) for oncology indications. The ATLab (Alpha Therapy Laboratory) Valenciennes in Onnaing, France, will produce lead-212 radioligand therapies. As a result, the project will receive public support of almost €3.8
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.
On 10 March, the National Health Service Blood and Transplant (NHSBT) opened a new Clinical Biotechnology Centre (CBC) with the aim of improving the UK’s ability to develop and manufacture cell and gene therapies. This is important due to the UK’s currently limited short-scale manufacturing capacity.
However, the biopharma industries realised that traditional vaccine development and manufacturing techniques, which take around five to 10 years for initial development to large-scale distribution, 1 were inadequate to meet the growing demand for COVID-19 vaccines. Digital technologies for smart vaccine manufacturing.
2,3 Clinical implementation of CAR T-cell technology requires a reproducible T-cell manufacturing platform, which necessitates effective gene-transfer tools and T-cell culture conditions. Due to shipping and manufacturing requirements, the time from a patient being included in the CAR T programme to receiving therapy can be several weeks.
Pharmaceutical wholesalers act as intermediaries between pharmaceutical manufacturers and retailers and facilitate the delivery of the right medicines in a timely, efficient, and secure manner. The post Leading pharmaceutical wholesalers appeared first on Pharmaceutical Technology. Discover the top pharmaceutical wholesalers.
Overreliance on automation can lead to complacency and blind trust in technology, leading to potential oversight of critical errors or deviations. It offers a novel solution to the challenge of data integrity by providing a tamper-proof record of transactions from raw material sourcing to final product distribution.
Pharmaceutical supply chains are extremely vulnerable to the effects of climate change and face many challenges from sourcing to distribution. Wildfires, floods, landslides, and drought, often in places unused to such extreme weather events, are causing a global shift in public health issues and can quickly lead to a humanitarian crisis.
As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.”
Prior to selling drugs or medical products in any country, pharmaceutical companies must prove compliance and gain the regulatory approval required by the country in which the goods will be distributed in. So, with mandates in place, how do manufacturing facilities meet these compliance goals? The dominion of data.
Researchers at the Indian Institute of Science created footwear that can self-regulate the pressure distribution when a person walks, helping to avoid pain and friction that can lead to issues for people with diabetes.
Intas Pharmaceuticals Ltd- (45 positions) Walk-In Interviews for Multiple Positions On 5th March 2023 Job Description Company Profile: INTAS Pharmaceutical is a leading, vertically integrated global pharmaceutical formulation development, manufacturing, and marketing company.
CGT Catapult highlighted that based on the database, “most ATMP trials in 2023 were gene therapies (76 percent), with an even distribution between in vivo and ex vivo gene therapy trials.” Additionally, the data showed that oncology remains the dominant therapeutic area under investigation, accounting for 41 percent of trials.
Shortages can lead to medicine rationing, delay in critical treatments and can mean patients may need to use less-effective alternatives and face an increased risk of medication errors, it said. Medicine shortages are a global health problem and are increasingly affecting European countries, according to EMA.
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.
Forge Biologics has received a qualified person (QP) declaration to manufacture adeno-associated virus (AAV) gene therapies to support European clinical programmes. The company stated that a European QP has completed an in-depth audit at its manufacturing facility in Columbus, Ohio, US.
French biopharmaceutical company ORPHELIA Pharma has entered an exclusive agreement with Tanner Pharma Group to manage the supply and distribution of Ped-TMZ, also known as Kimozo (temozolomide 40mg/ml, oral suspension) in European countries.
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.
Quoin Pharmaceuticals and Endo International subsidiary Endo Ventures have signed a licence and distribution agreement and a supply agreement to develop, register, supply, market and distribute the former’s QRX003 exclusively in Canada. A lead product of Quoin, QRX003 is a topical lotion intended to treat Netherton Syndrome.
Aseptic is best applied to smaller, discrete techniques, behaviours and/or processes, eg, aseptic manufacturing and aseptic process simulation. The very linkages between each manufacturing control lacks proper understanding and awareness of aseptic techniques. The term ‘sterile’ is not to be used casually.
To prepare for the second order effects of the IRA, one important step that we recommend for manufacturers is to clearly articulate and outline the remaining uncertainties regarding how the IRA will be implemented by CMS and identify scenarios most likely to impact their products. Acceptance and Consideration of Manufacturer Evidence.
is one of the leading API & Formulations manufacturing and marketing pharmaceutical Company. Managing distribution channel members such as Stockiest, Distributors & Chemists. Job Description. Alembic Pharmaceuticals Ltd. Experience up to 6 months. Prescription generation. Handle sales promotion activities.
In the near term, manufacturers may need to reconsider price increase strategy given inflation penalties for Medicare beneficiaries. Reduced patient out-of-pocket (OOP) costs in Part D have the potential to reduce beneficiary reliance on foundation support, with commensurate reductions in manufacturer donations required.
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.
Victoza, Copaxone, Lupron, Zoladex, Sandostatin, and Somatuline are some of the popularly marketed peptide API therapeutic drugs while more than 600 peptide-based pharmacological leads are being investigated worldwide, across various phases of development.
The pharmaceutical industry requires specialised and cost-effective commercial packaging solutions to improve efficiency and preserve the integrity of products through the entire supply chain, from primary packaging and labelling to shipping, delivery, storage and distribution to end users.
is one of the leading API & Formulations manufacturing and marketing pharmaceutical Company. Managing distribution channel members such as Stockiest, Distributors & Chemists. Alembic Pharmaceuticals Ltd- Opening for B.Pharm/ D.Pharm/ MBA/ Science Graduate Freshers-Apply Now. Job Description. Alembic Pharmaceuticals Ltd.
” This combination maps the distribution of metabolites, drugs and contaminants in tissue sections while providing the analytical power and identification capabilities of chromatography methods.
Find the leading API biologics companies in contract marketing. The list includes providers of development services, biologics management supply chain solutions, clinical trial services, commercial and logistics services, as well as packaging, labelling and distributing services for biologics.
Additionally, OSD manufacturing approaches are well developed, with processes that ensure a repeatable distribution of ingredients, uniformity in dissolution, and bioavailability, which verify that the drug product is safe and effective. Compared to other dosage forms, tablets are simpler to manufacture, package, and transport.
Clinical packaging and labelling follow stringently controlled procedures and high-standard quality control measures to assure the safety and functionality of investigational medicinal products, during their storage, distribution, and use.
Understanding them can help you make an informed decision that will lead you in the right direction. Making and Distributing Products The first decision you need to make is whether you prefer to work for a manufacturer or a distributor. Just note, this might lead to miscommunication in some instances.
The European Medicines Agency (EMA) defines counterfeit medicine as being “made by someone other than the genuine manufacturer, by copying or imitating an original product without authority or rights and [infringing] trademark law”. But what exactly does this look like? . The first line of defence.
The current shortages have been spurred by a number of issues, some short-term and many long-term, that have plagued the manufacture and development of antibiotics. One of the reasons is the most evident: the winter months often lead to greater need for antibiotics, and that can lead to shortages.
From the manufacturer perspective, payer policies and legislation on combination therapy pricing are impacting global development, pricing, access, and commercialization strategies. When 1+1 ≠ 2 In theory, combining two or more branded agents can lead to a price that exceeds SoC monotherapy.
This deal, therefore, serves as a threat to other vaccine developers with authorisations for distribution in the EU, including Moderna, Novavax, and Sanofi. More significantly, the revised contract secures about 70 million vaccine doses every year from 2023 to 2026 for member states, leaving little space in the market for competitors.
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.
Monoclonal antibody conjugates for cancer treatment is a key innovation area in immuno-oncology The primary purpose of antibody drug conjugates (ADCs) is to increase the efficacy of anticancer medications by minimising systemic drug distribution and targeting specific cells. Kadcyla, one of the two marketed drugs, is manufactured by Roche.
This has led pharmaceutical equipment manufacturers to react quickly, while maintaining due levels of diligence and social responsibility. Each of these places us in a position to work alongside the customer to optimise the manufacturing process and develop new solutions.
This includes chemistry, manufacturing and controls (CMC) operations, as well as supply chain management, corporate governance, and “oversight of multi-product, multi-ton production and multi-billion-dollar inventory management”. Previously, Rayne held the role of Chief Operating Officer at Capsida Biotherapeutics.
It includes manufacturers, distributors, wholesalers, pharmacies, and more – all must work together to keep medications readily available. This can also lead to decreased customer satisfaction and damage any business’s reputation.
This is likely due to the complexities and risks associated with drug development and manufacturing and pursuing new opportunities to drive positive change towards a more sustainable future. Extreme temperatures lead to more cases of heat stroke, which can be fatal or lead to chronic health issues.
There are many different ways to sell the products you manufacture. They buy products from manufacturers and sell them to retailers. At the end of the day, distributors simplify the sales process for manufacturers. That’s why so many manufacturers want to do it. Distributors are go-betweens. Don’t worry!
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