Latest news with #GMP-compliant
Time Business News
10 hours ago
- Business
- Time Business News
Industrial Mixing Tank: Design, Function, and Applications
Industrial mixing tanks are a cornerstone of modern manufacturing processes across various sectors, including pharmaceuticals, food and beverage, chemicals, cosmetics, and water treatment. These tanks are engineered to mix, blend, combine, or emulsify substances—typically liquids, powders, and semi-solids—into a homogeneous product. Their design and functionality play a crucial role in ensuring process efficiency, product consistency, and safety. The design of a mixing tank is determined by the specific requirements of the process it serves. The key design elements include: Tanks are commonly made from stainless steel, carbon steel, plastic (such as polyethylene or polypropylene), or lined materials for corrosion resistance. Stainless steel is preferred for food-grade and pharmaceutical applications due to its hygienic properties. Cylindrical tanks with conical or dished bottoms are widely used to enhance mixing efficiency and ease of drainage. Horizontal tanks are used in space-constrained facilities, though vertical tanks offer better mixing performance. The agitator or mixer is the heart of the mixing tank. Common types include: Propeller Agitators – High-speed mixers for low-viscosity liquids. – High-speed mixers for low-viscosity liquids. Turbine Agitators – Suitable for mixing medium to high-viscosity fluids. – Suitable for mixing medium to high-viscosity fluids. Anchor and Paddle Mixers – Ideal for viscous or shear-sensitive products. Baffles are vertical strips inside the tank that prevent vortex formation and improve mixing. Other features might include heating/cooling jackets, sensors, and CIP (Clean-In-Place) systems. The primary function of a mixing tank is to create a uniform blend of ingredients. Depending on the process, this could involve: Homogenization: Creating a consistent mixture from multiple components. Creating a consistent mixture from multiple components. Suspension: Keeping solid particles evenly distributed in a liquid. Keeping solid particles evenly distributed in a liquid. Emulsification: Blending immiscible liquids like oil and water. Blending immiscible liquids like oil and water. Heat Transfer: Heating or cooling contents during mixing. Heating or cooling contents during mixing. Chemical Reactions: Acting as a reactor vessel for mixing reactants. Control systems allow operators to adjust mixing speed, temperature, and duration, ensuring precise processing tailored to each batch or product type. Industrial mixing tanks are used in a broad range of applications: Used for mixing sauces, dairy products, beverages, and flavorings while maintaining hygiene and consistency. Tanks often include temperature control for pasteurization. Essential for blending chemicals, solvents, or resins. Some tanks are built to withstand high pressures and corrosive substances. Used for producing liquid medications, vaccines, and personal care products. Precision and cleanliness are critical, often requiring GMP-compliant tanks with sterile mixing environments. Used for coagulation, flocculation, and chemical dosing processes to treat water or wastewater efficiently. Tanks mix creams, lotions, shampoos, and gels, often with integrated heating and vacuum systems to achieve the desired texture and stability. Industrial mixing tanks are indispensable tools for modern production, enabling efficient and reliable processing across industries. Their design is tailored to meet specific processing requirements, and advancements in materials and automation continue to improve their performance and sustainability. Choosing the right tank design and configuration is critical for product quality, process efficiency, and compliance with industry standards. TIME BUSINESS NEWS
Business Wire
a day ago
- Business
- Business Wire
AGC Biologics' Heidelberg Site Supplies Drug Substance for Phase II Studies of Valneva's Tetravalent Shigella Vaccine Candidate
SEATTLE & HEIDELBERG, Germany--(BUSINESS WIRE)-- AGC Biologics, your friendly CDMO expert, today announced a development and manufacturing services agreement with specialty vaccine company Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) to supply drug substance for an investigational four-valent Shigella bioconjugate vaccine at the CDMO's Heidelberg facility. Valneva exclusively licensed the vaccine candidate from LimmaTech Biologics AG, which previously worked with AGC Biologics to establish GMP-compliant manufacturing and quality control of the vaccine's complex protein-polysaccharide conjugates for first-in-human studies. The objective of the new partnership with Valneva is to establish phase II supply relying on the ability of AGC Biologics' Heidelberg site to guide complex molecules through clinical stages. Valneva and LimmaTech announced the launch of a Phase 2 infant study in April, and a Phase 2b Human Challenge Study (CHIM) in November 2024. Shigellosis is the second leading cause of fatal diarrheal disease worldwide, strongly contributing to pediatric morbidity and mortality. It is estimated that up to 165 million infections are due to Shigella, of which 62.3 million occur in children younger than five years. Developing an effective vaccine to prevent this deadly disease is a public health imperative for many areas of the world. "Our site's unique ability to handle complex molecules and multi-valent assets can help this potentially life-saving program reach its next clinical milestone," said Dieter Kramer, Senior Vice President and General Manager, AGC Biologics Heidelberg. "We appreciate Valneva entrusting our team of experts with this challenge and are honored to contribute to efforts that aim to prevent millions of deadly infections in the future." AGC Biologics runs multiple cGMP microbial fermentation lines at its Heidelberg facility. The site has produced biologics products for 40 years. It offers developers freedom-to-operate strain development, proven experience with different bacterial and yeast systems, proprietary plasmid DNA (pDNA) and messenger RNA (mRNA) platforms, large-scale tanks for late-phase protein refolding, the ability to take on early-phase and fast track projects, and late-phase and commercial expertise. To learn more about the microbial system-based biologics, pDNA and mRNA manufacturing site in Heidelberg, visit For more information on AGC Biologics' global CDMO services across all modalities, go to About AGC Biologics AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, to provide friendly and expert services. We provide world-class development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with locations in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba and Yokohama, Japan. We currently employ more than 2,600 Team Members worldwide. AGC Biologics is a part of AGC Inc.'s Life Science Business. The Life Science Business runs 10+ facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit
Time Business News
20-07-2025
- Business
- Time Business News
Pharma & Research Laboratories in Canada
Canada is recognized as a world leader in pharmaceutical research, development, and innovation. Highly equipped Pharmaceutical Laboratories and a regulatory structure that favours growth give the country a leading edge in medical and biotech advances. If you are a pharmaceutical company, healthcare provider, or a biotech start-up, the potential for partnerships with a reputable Canadian lab is both broad and profound. Pharmaceutical laboratories play a crucial role in developing safe and effective drugs and treatments for patients. These laboratories are key to: Conducting clinical research and trials. Developing new drugs and formulations. Maintaining compliance with quality standards and regulations. Advancing vaccine and biotechnology research. There are numerous reasons the world owes Pharma Laboratories a great debt for the company's significant contributions to public health. They are the unsung heroes of modern medicine, from cancer research to vaccine development. Lab Canada has been expanding at an unprecedented pace in the last few years. With strong government support, significant investment in research and development, and a highly skilled workforce, Canadian labs are making notable strides in pharmaceutical science. Canada is listed as one of the world's leaders in clinical trials, biologics research, and biotech innovation. The Canada lab has some of the best good manufacturing practices (GMP-compliant) and technology in the industry, which is unmatched anywhere. Many of these labs are also ISO-certified, meaning they adhere to international quality standards and maintain a safe testing environment. Most Canadian Pharmaceutical Laboratories Offer services that cater to all aspects of the pharmaceutical development cycle. These include: Analytical Services: Analysis for chemicals, stability testing, and testing of raw materials. Analysis for chemicals, stability testing, and testing of raw materials. Formulation: Dosage formulation including tablets, capsules, AND injectables, etc. Dosage formulation including tablets, capsules, AND injectables, etc. Microbiology Testing: Testing for harmful microorganisms in products. Testing for harmful microorganisms in products. Regulatory Submission: Supply relevant information for regulatory filings. Supply relevant information for regulatory filings. Bioavailability & Bioequivalence Studies: Efficacy of the drug being compared with the standard. From small batch testing to vast pharmaceutical manufacturing, be assured that Canadian Analytical Laboratories is our trusted partner in innovation and dependability. When choosing a laboratory, reliability, compliance, and innovation are non-negotiable. Here are some reasons why getting a Canadian lab is a good business decision: Elite Level Standards: Canadian labs comply with Health Canada & FDA standards. Canadian labs comply with Health Canada & FDA standards. Cutting-edge Technology: These laboratories are equipped with the best-of-breed tools, from AI-powered analytics to robotics automation. These laboratories are equipped with the best-of-breed tools, from AI-powered analytics to robotics automation. Expertise & Talent: With highly educated chemists, biologists, and lab techs, quality is a given. With highly educated chemists, biologists, and lab techs, quality is a given. Nut Data Integrity: Security and accuracy should be maintained in all testing activities. Security and accuracy should be maintained in all testing activities. Teamwork: Easily collaborate with research and manufacturing teams worldwide. Pharma Labs also services more than drug manufacturers. These include: Biotechnology Companies Healthcare Providers Nutraceutical Brands Academic and Research Institutions Veterinary Medicine Providers From diagnostics to commercial production, Laboratories Canada delivers tailored services to different industries. Laboratory needs continue to evolve in response to global health threats. Canada is investing heavily in AI for diagnostics, personalized medicine, and green chemistry. The future of Pharma Laboratories in Canada is bright, sustainable, and innovative. In today's fast-paced world, having the right partner can make all the difference when developing innovative pharmaceutical products. Pharma Laboratories Canada upholds the highest standards of quality, innovation, and compliance among its partnered drug developers and industry professionals in the pharmaceutical, biotechnology, and healthcare sectors. Whether you're introducing a new drug or in the process of testing, having a Canadian laboratory means your project is in reliable hands. When it comes to Research and Development, Canada laboratory represents trust, effectiveness, and innovation. Q1. What are the services provided by Pharma Laboratories in Canada? A: They provide analytical testing, formulation development, microbiology testing, support for clinical trials, and regulatory consulting. Q2. Do Canadian laboratories meet the international standard? A: Yes, most Canadian labs comply with GMP, ISO certifications, and follow FDA and Health Canada regulations. Q3. How Do I Find the Best Canadian Lab for My Project? A: Look at lab accreditation, experience, technology, turnaround times, and customer reviews. Q4. Do foreign pharmaceutical companies support Canadian labs? A: Absolutely, Canadian labs frequently partner with overseas clients and provide comprehensive services, including logistics, documentation, and regulatory applications. Q5. These labs are only for drugs? A: No, they additionally cater to the biotechnology, nutraceuticals, academic research, and veterinary sectors. TIME BUSINESS NEWS
Korea Herald
18-07-2025
- Business
- Korea Herald
MFDS Clears DeepQure's HyperQure™ for Clinical Trial in Atrial Fibrillation
SEOUL, South Korea, July 18, 2025 /PRNewswire/ -- DeepQure announced today that South Korea's Ministry of Food and Drug Safety (MFDS) has approved a clinical trial of HyperQure™ RDM System, the company's novel laparoscopic renal denervation (RDN) system, for the treatment of atrial fibrillation (AF). The trial is designed to evaluate the safety and efficacy of laparoscopic RDN in patients with recurrent AF following pulmonary vein isolation (PVI) and resistant hypertension. It will be conducted as a multicenter, prospective, single-arm, open-label exploratory study. HyperQure™ is a next-generation laparoscopic RDN device developed over the past decade under the leadership of Professor Chang-Wook Jeong at Seoul National University Hospital. By adopting an extravascular approach, HyperQure™ addresses key limitations of conventional intravascular RDN, offering direct anatomical access to renal nerves with the potential for improved precision and outcomes. DeepQure is also conducting RDN clinical trials for resistant hypertension in both South Korea and the United States. Patient enrollment is nearing completion domestically, while trials are actively underway at five major academic medical centers across the U.S. The MFDS's approval for this new indication marks an important milestone, expanding HyperQure™'s potential from hypertension to atrial fibrillation and reinforcing its technical scalability and multi-disease therapeutic potential. HyperQure™ is ISO 13485–certified, GMP-compliant, and was designated as Innovative Medical Device No. 36 by the MFDS, underscoring its clinical relevance and breakthrough innovation. "This approval validates HyperQure™ as a next-generation solution that overcomes the limitations of traditional RDN techniques," said a DeepQure spokesperson. "With parallel trials in resistant hypertension and now atrial fibrillation, we are accelerating our push into the global cardiovascular market with a truly differentiated solution." About DeepQure DeepQure is a medical technology company pioneering minimally invasive therapies for cardiovascular and autonomic nervous system disorders. Founded by experts in clinical medicine, engineering, and global healthcare, the company is focused on developing breakthrough solutions that address unmet needs in cardiovascular diseases. DeepQure is headquartered in Seoul, South Korea, with clinical programs active in both Korea and the United States. About HyperQure™ RDN System HyperQure™ is DeepQure's proprietary laparoscopic renal denervation (RDN) system designed to treat conditions such as resistant hypertension and atrial fibrillation. Unlike conventional intravascular approaches, HyperQure™ utilizes an extravascular route to access and ablate renal nerves with enhanced precision. The system has been designated as an Innovative Medical Device by the Korean MFDS and has obtained ISO 13485 and GMP certifications, enabling global clinical deployment.
Business Wire
16-07-2025
- Business
- Business Wire
Elevated Signals Launches New Planning & Scheduling Module to Drive Profitable, Scalable Production
VANCOUVER, British Columbia--(BUSINESS WIRE)-- Elevated Signals, the leading manufacturing operations software for regulated industries, has launched its new Planning & Scheduling module, giving fast-growing manufacturers a smarter way to plan, adjust, and optimize production. Our new module replaces these disconnected tools with a smarter, integrated system that brings structure to the chaos, helping manufacturers stay aligned, agile, and ahead of demand The new module provides teams with agility through a drag-and-drop interface that automatically adjusts all related steps in the production plan. This enables them to accurately model capacity, avoid over- or underproduction, and respond faster to demand, cutting delays, reducing labour costs, and maximizing throughput. Designed for regulated industries such as cannabis, nutraceuticals, food, and beverage, Elevated Signals brings all production data, including inventory, QA, work orders, and planning, into one flexible system. With everything in one place, manufacturers can easily trace batches, generate GMP-compliant records, and be audit-ready without the last-minute scramble. No more stitching together spreadsheets, calendars, and disconnected tools. Teams have instant clarity and can focus on production, not tracking down data. 'Factory managers need to hit production targets reliably and predictably, but most are still relying on spreadsheets and whiteboards to plan their operations,' said Amar Singh, CEO and co-founder of Elevated Signals. 'That leads to missed deadlines, team stress, inventory issues, and ultimately missing profitability and revenue goals. Our new module replaces these tools with a smarter, integrated system that brings structure to the chaos - helping manufacturers stay aligned, agile, and ahead of demand.' 'We've been using a tangle of spreadsheets to manage our production plans,' said Paul Brownfield, General Manager, QAP, Organnicraft Production Inc. 'Elevated Signals' Planning & Scheduling module will bring that whole process into one clear, interactive view. It'll ensure our plans are up-to-date, easy to edit, much more resilient, making team coordination effortless - especially when things change last minute.' With the Planning & Scheduling module, teams can: Connect planning directly to BOMs, inventory levels, SKUs, batches, work orders, QA requirements, and labour needs Easily model and see plans in calendar or Gantt-style views Create reusable templates for core workflows for greater efficiency Schedule from ship dates or start dates, with built-in buffer logic Looking ahead, this launch is just the beginning. Upcoming features like forecasting, costing, and AI insights will give manufacturers even greater control over performance and profit. About Elevated Signals Elevated Signals builds manufacturing operations software for regulated industries, including cannabis, nutraceuticals, food, and beverage. Its GMP-ready platform connects inventory, quality & compliance, planning, and costing into one easy-to-use system, empowering teams to plan smarter, act faster, and scale with confidence. Learn more at
