Mikrobiell tillverkning för kommersiellt utbud Sverige

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  The Benefits and Challenges of Microbial Manufacturing at Scale

  These microbe-based manufacturing of products have several benefits. The first and most obvious pro is that it is good for the environment. Compared to traditional manufacturing methods, microbial manufacturing is cleaner (produces less waste), greener (requires less energy) and has a reduced resource requirement. Microbes are also widely adaptable. There are couple of thousand species that can be grown in a variety locations and hence we may be able to produce materials in places otherwise not suitable for GMP Semaglutid tillverkning. That said, keep in mind that using a ton of microbes can be problematic as well. Such as contamination where all the germs become harmful and mix with a good pleasant microbe, or over grows if there is an overpopulation of microbes. It is important to control these hurdles so that production continues with the same level of safety, efficiency and quality.

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  Revolutionizing How We Make Everything from Medicine to Food

  Microbial manufacturing is revolutionizing food and drug production. Through microbes we produce proteins and enzymes that are required for many medicinal products such as insulin to help people with diabetes maintain their health. For example, without the aid of microbes we would not be able to synthesise the insulin and hormones needed to survive. In addition, microbes can generate food enzymes that enhance the flavor and feel of some foods that are beloved to our taste buds too. And there is a growing tradition of experimentation as scientists continue to look for new avenues such as manufacturing plastics or other harmful materials in an eco-friendly manner through microbes. That´s a giant-step for the protection of our plant!

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  How Microbial Manufacturing is Changing the Landscape of Industry and Sustainability

  Microbial production is making the world a better place by developing sustainable methods to create products. When making valuable materials with microbes, we should not have to rely on non-renewable resources like oil or gas. These resources are limited and will finish one day and also they have adverse impacts on the environment. Microbial manufacturing helps us manufacture items in regenerative, zero-waste and no-harm ways (to ourselves or other life forms).

Why choose Yaohai Microbial Manufacturing for Commercial Supply?

• Kvalitetssystem och global regelefterlevnad

  Yaohai BioPharma, a top 10 Microbial CDMO, integrates quality and regulatory matters. We have a quality system that is fully compliant with the current GMP standards, as well as international regulations. Our team of regulatory experts has a deep understanding of world-wide regulatory frameworks. This lets us accelerate biological launches. We are able to guarantee traceable production procedures and high-quality products that conform with regulations from the US FDA, Microbial Manufacturing for Commercial Supply, Australia TGA, and China NMPA. Yaohai BioPharma has successfully passed an on-site audit conducted of the European Union's Qualified Person (QP) for our GMP quality system and production site. We also have been through the initial certification audits of the ISO9001 Quality Management System and ISO14001 Environmental Management System.

• Anpassning, effektivitet och kostnadseffektivitet

  Yaohai Bio-Pharma is experienced in the development of microbial-derived biologics We offer tailored RD solutions and manufacturing while keeping risks to a minimum We have used a variety of modalities including recombinant subunits vaccines (including peptides) growth factors hormones and Cytokines We've specialized in several microorganisms like yeast intracellular and extracellular secretion (yields up to 15g/L) and bacteria intracellular soluble and inclusion body (yields as high as 10g/L) We have also created a Microbial Manufacturing for Commercial Supply fermentation system to develop bacteria-based vaccines We are experts in optimizing processes increasing yields as well as reducing production costs Utilizing a strong technology team we ensure timely and quality project delivery to bring your exclusive products to market faster

• Robust försörjningskedja och tillverkningskapacitet

  Yaohai Bio-Pharma, a top 10 Microbial Manufacturing for Commercial Supply 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.

• Professionell expertis & lång erfarenhet

  Yaohai Bio-Pharma is a leading microbiological CDMO. Our focus has been on microbially produced Microbial Manufacturing for Commercial Supply and vaccines for human, veterinary and the management of pet health. We have state-of-the-art RD platforms and manufacturing methods which cover the entire procedure starting with microbial strain creation and cell banking, to process and method development to commercial and clinical production and implementation of cutting-edge solutions. Over the years we have gained vast expertise in bio processing using microbial sources. We have successfully delivered over 200 projects across the globe and have assisted our clients with navigating the regulations from the US FDA, EU EMA, Australia TGA, and China NMPA. We are able to react rapidly to market requirements and offer a customized CDMO services due to our expertise and knowledge.

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