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Fujifilm Corporation is spreading the wealth across two production units as the contract development and manufacturing organization (CDMO) juggernaut works through a cell therapy expansion. Fujifilm is dividing $200 million between a pair of subsidiaries.
Even as supplies of Novo Nordisk’s immensely popular GLP-1 drugs Ozempic and Wegovy start to stabilize, the Danish drugmaker continues to announce manufacturing and capacity upgrades at a rapid cli | Novo Nordisk Pharmatech, a unit that specializes in producing drug ingredients, is spending 1.5
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. For cell and gene therapy applications, you need a variety of speciality enzymes of the highest purity, specificity, and consistency.
As medical devices evolve and become more sophisticated, we are seeing a trend toward specialization. Building customized solutions for specialized disease states creates a nimbleness to respond to new conditions and develop a platform uniquely suited for that condition. It will become commonplace to see devices that break new ground.
As demand for advanced therapies increases, so does the need for more specialized supply chain support, as these products have strict transportation and handling requirements. It is crucial to ensure supply chain risks are mitigated and have proactive strategies in place to address unforeseen challenges before they become an issue.
Crucially, January 2023 marked a key moment: the Medicines and Healthcare products Regulatory Agency (MHRA) granted Celadon Pharmaceuticals the first good manufacturing practice (GMP) registration since legalisation in 2018 for high Δ9-tetrahydrocannabinol (THC) cannabis active pharmaceutical ingredient (API).
Now, the manufacturing arriviste—which was founded in 2020—is expanding its production network again with the acquisition of Switzerland's Baccinex, which specializes in fill and finish services.
While maintaining a healthy manufacturing industry for production of ‘high tech’ pharmaceuticals, Europe has stepped away from manufacturing essential medicines and active pharmaceutical ingredients (APIs) due to unrelenting price pressures and is now heavily reliant on the import of these critical ingredients.
Ajinomoto’s Forge Biologics acquisition brings contract development and manufacturing organization capabilities in gene therapy. Forge specializes in manufacturing AAV vectors used to deliver these therapies.
When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial.
Endo India Par Formulations-Walk-In Interviews for Quality Control/ Manufacturing On 4th Dec’ 2022. Endo India Par Formulations is a pharmaceutical company that develops, manufacturers and markets safe, innovative and cost-effective pharmaceuticals that help improve patient quality of life. Job Description. Job Location: Indore.
When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial.
Speciality pharmacies play a crucial role in medication dosing, disease and side effects management, and patient care. Speciality pharmacies provide comprehensive medications for individuals with serious medical conditions requiring complex treatments, including cancer, cystic fibrosis, haemophilia, hepatitis, HIV, and others.
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. This can result in reductions in costs for our customers.”
Avid specializes in manufacturing biologic products for companies at all stages of development. CDMO Avid Bioservices is being acquired by the private equity firms GHO Capital Partners and Ampersand Capital Partners. The post Private Equity Is Picking Up Biologics CDMO Avid Bioservices in $1.1B
Developing and manufacturing complex novel oral solid dose products of highly potent compounds requires specialized expertise. The degree of potency and specific risks will determine the level of containment needed to ensure operator safety and prevent cross contamination at the development and manufacturing facility.
Developing and manufacturing highly potent oral solid dose drugs to respond to increasing demand in the industry requires specialized procedures and expertise.
an innovator in the field of orthopedic surgical robots, today announced that its TMINI Miniature Robotic System has received Special 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use with implants from three additional implant manufacturers. THINK Surgical, Inc., ” About THINK Surgical, Inc.
Lorrie is leader of the GAMP laboratory Special Interest Group and Co-Chair of the GAMP Data Integrity Special Interest Group. The post GAMP 5 update: computerized system expectations for pharma manufacturers appeared first on European Pharmaceutical Review.
Developing and manufacturing complex novel oral solid dose products of highly potent compounds requires specialized expertise. Learn more about creating a safe, efficient and scalable drug development program with HPAPIs in this eBook.
For pharma and biotech companies, there are many advantages to partnering with a Contract Development and Manufacturing Organisations (CDMO): they can access more specialized knowledge, state-of-the-art equipment, and qualified staff, as well as reduce their total cost of ownership, all while maintaining speed to market.
With over 18 years of experience, Alexander Dragitsch is a commercial customer service contract manufacturing (CSCM) manager at Baxter’s Halle/Westfalen facility in Germany. The Halle customer service team is a “one-stop-shop” for client requests when it comes to commercial drug product manufacturing,” explains Dragitsch.
The Food and Drug Administration (FDA) has successfully inspected Nexus Pharmaceuticals’ pharmaceutical manufacturing facility located in Pleasant Prairie, Wisconsin, US. The inspection will allow the company to commence commercial operations at the three-storey, 84,000ft² manufacturing facility.
What Can Independent Manufacturer Sales Reps Expect From Manufacturers, Suppliers, Vendors & Service Providers. When working directly with Manufacturers, there are several things that can but should never be expected of them by independent sales reps. Review the following examples. Review the following examples.
However, if clothing that contains health sensors is to become widely adopted, it would be beneficial if such technologies are compatible with existing industrial manufacturing processes. The less ‘specialized’ a technology is to manufacture, the less expensive it is and it is more likely that it will be used by many people.
Processes in pharmaceutical manufacturing such as processing, milling, grinding, and mixing, are associated with the generation of dust. The researchers highlighted that the risks of hazard exposure include danger to the health of operators and cross-contaminations during manufacturing.
Bharat Biotech-Production, Quality Control, Quality Assurance, Packing & Visual Inspection- Apply Now Job Description Bharat Biotech International Ltd is a Multidimensional biotechnology Company specializing in product-oriented research, development and manufacturing of vaccines and biotherapeutics is engaged in developing next -generation vaccines (..)
The agreements also include the manufacturing and commercialisation of the two assets, including DB-1303 and DB-1311, across the globe. As part of the new deals, BioNTech will have commercial rights to the ADCs worldwide, excluding mainland China, the Hong Kong special administrative region and the Macau special administrative region.
Conclusions from the meeting of the special European Council (17-18 April 2024) have recognised a need for new European competitiveness deal “anchored in a fully integrated Single Market”.
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.
However, scaling processes up to a manufacturing scale is far from straightforward. The challenges with scaling up mAbs therapy production When developing a mAb therapeutic, there has traditionally been inconsistency between early lab processes, pilot processes and commercial manufacturing.
CGT trials operate with much lower volumes of manufactured final product. CGT have highly unique and specializedmanufacturing processes. This implies precise (and frequently changing) timeline planning for drug manufacture and delivery. This is a primary factor for the staggeringly high unit cost of CGT.
Johnson & Johnson is a worldwide corporation that manufactures not just medical devices and surgical gear but also medicines, biotechnology, and products for personal hygiene. Ethicon, a J&J subsidiary, manufactures the majority of surgical and medical devices. Medtronic is a pioneer in developing innovative surgical equipment.
Pharmaceutical crime also harms the legitimate manufacturers, who are impacted by counterfeits that can erode brand reputation and reduce the funds available for product research and development. This gives consumers the ability to validate the authenticity of their purchases with the use of custom holograms.
Pharmaceutical Technology Europe® spoke with Leonardo Vincenzi from CONTINUUS Pharmaceuticals, a US company that specializes in process development, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.
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.
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.
SGS owned contract development and manufacturing organisation (CDMO), Quay Pharma , is the recipient of one of more than 120 of International Trade category awards given out in 2022. Quay Pharma has enjoyed notable success in the US, where it has opened a dedicated sales office and a development and manufacturing facility, noted SGS.
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”.
Eugia Pharma Specialities Limited is Subsidiary of Aurobindo Pharma Limited, Aurobindo Pharma Ltd’ (APL). APL is a growing India multinational pharmaceutical manufacturing firm with turnover of over US$2.8 Job Description.
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