Fabricarea de vaccinuri pe bază de VLP România

• Safe, Effective, and Scalable Manufacturing

  VLP vaccines - VPP begins with construction of a small virus-like particle in the lab. But fear not, because these particles are NOT contagious to humans! Scientists insert tiny bits of the germs that these vaccines will provide protection which is also known as VLPs. 

• VLP-based Vaccine Process

  VLP vaccines are an advancement in the field of vaccine science. They can be quickly and easily produced at scale so that we are better equipped to protect people in times of emergencies or when a disease breaks out. They are also good at keeping us, well safe from disease! That is even more true today, when germs seem to evolve almost overnight.

• Enhancing Immunity with VLP-based Vaccines - A Promising Future

  VLP technology can also be partnered with new technology (such as mRNA used in the covid vaccines). mRNA is a type of genetic material that gives the body instructions. Together with mRNA, using VLPs allows researchers to develop a vaccine for teaching our bodies how to fight germs more effectively. Combine, you get more potent vaccines that are also less likely to fail.

Why choose Yaohai VLP-based Vaccine Manufacturing?

• Sistemul de calitate și conformitatea cu reglementările globale

  Yaohai BioPharma is a Top 10 Microbial CDMO that incorporates quality control and regulatory matters. We have a quality system which is in line with current GMP standards and international regulations. Our regulatory team is knowledgeable in global regulatory frameworks to accelerate biological launches. We ensure traceable manufacturing processes and top-quality products that are compliant with the requirements of the US FDA, EU EMA, Australia TGA, and VLP-based Vaccine Manufacturing. Yaohai BioPharma has successfully passed the audit on site of the European Union's qualified Person (QP) for our GMP quality system and production site. In addition, we've cleared the first certification audits of the ISO9001 Quality Management System, ISO14001 Environmental Management System, and ISO45001 Occupational Health and Safety Management System.

• Experiență profesională și experiență vastă

  Yaohai Bio-Pharma is a leading in VLP-based Vaccine Manufacturing CDMO. Our main focus has been the production of microbial vaccinations and therapeutics to treat pets, human and veterinary health. We possess cutting-edge RD and manufacturing technology platforms that cover the entire manufacturing process from the engineering of microbial strains, to cell banking processing and method design to clinical and commercial manufacturing, making sure that we can ensure the successful delivery of the most advanced solutions. We have accumulated a huge quantity of knowledge in the bio processing microbial field. More than 200 projects have been successfully completed and we help our clients comply with regulations like those of the US FDA as well as EU EMA. We also help them to navigate Australia TGA and China NMPA. We are able to respond rapidly to market requirements and offer customized CDMO services due to our experience and expertise.

• Lanț de aprovizionare robust și capabilități de producție

  Yaohai Bio-Pharma, a top 10 VLP-based Vaccine Manufacturing of biological products, is a specialist in microbial fermentation. We have set up a modern facility that has robust RD capabilities and advanced infrastructure. Five lines of production for drugs conforming to GMP standards to purify and ferment microbial cells along with two fill and finish lines for vials as well as cartridges and needles pre-filled are readily available. The fermentation scales available for use range from 100L to 2000L. Filling specifications for vias are 1ml to 25ml, whereas pre-filled syringe or cartridge filling requirements are between 1-3ml. The production workshop is cGMP certified and offers the availability of commercial and clinical samples. The large molecules manufactured in our facility are available for delivery worldwide.

• Personalizare, eficiență și rentabilitate

  Yaohai Bio-Pharma has experience in the manufacture of biologics derived from microorganisms. We offer tailored RD solutions and manufacturing while minimizing the risk. We have worked with diverse methods, such as VLP-based Vaccine Manufacturing of vaccines (including peptides), growth factors, hormones, and Cytokines. We specialized in multiple microbial hosts, including yeast extracellular and intracellular (yield up to 15 g/L) bacteria periplasmic secretion, soluble intracellular, and inclusion bodies (yield up to 10 grams/L). We also have a BSL-2 fermentation platform to create bacterial vaccines. We specialize in improving processes, increasing product yields, as well as reducing production costs. We have an efficient technology team that guarantees timely and quality project delivery. This allows us to deliver your exclusive products quicker to market.

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