BSL-2 Microbial Development and Manufacturing

• A Closer Look at the Processes Involved in BSL-2 Microbial Development

  When you want to study a microbe, the first thing you do is get one. They then grow the bacteria in a lab. Safety Measures At Work for Scientists Taking Into Account Security Policies In BSL-2 Labs This is important since it retains the microbes within just the laboratory, protecting against them from getting out and causing harm to men and women or pets outside the laboratory. Safety Comes First As Always Beside the opportunity of greatly detailed investigation researchers would employ all the means available to ensure that these microbes are still safe once they achieve successful growth. They investigate the operation of microbes and treatment options for a variety of ailments. This coverage is re-posted with permission from The Scientist, where the article was originally published on May 6th, 2015Read moreWhen it comes to consuming living microbes, all of them have everything they need to stay alive and efficaciously set up shop within our bodies; that's why this type research study, like the one released today, is so crucial in developing a better grasp over how we can most wisely access such tiny organisms for our overall health.

• Designing and Optimizing Manufacturing Workflows for Biologics and Vaccines

  The process of developing and testing the microbe is followed by mass production of it for application. This also had to done beautifully, so lot of planning and organizing went in here. Yaohai team is committed to improving manufacturing efficiency in every step in this process. At the same time they produce high quality products too e.g. vaccines to immunize people against various illnesses. It is from these manufacturing workflows, the end products are designed to be safe and efficient for all.

• Ensuring Safety and Efficacy in BSL-2 Microbial Development and Commercialization

  Risk management is the pragmatic principle guiding microbial design at every stage of development from a safety perspective. They has always had a strict test center to ensure that all microbial products manufactured by the company can be used on human or animals. In addition, they maintain relationships with regulators to protect the safety and quality control of products. Thus, it is crucial for these products to be properly tested before being released in public so that everyone can use them without any life hazards.   

Why choose Yaohai BSL-2 Microbial Development and Manufacturing?

• Tugev tarneahel ja tootmisvõimalused

  Yaohai Bio-Pharma, a top 10 producer of biological products, is a specialist in microbial fermentation. We have established an advanced facility that is equipped with modern facilities and strong RD manufacturing capabilities. We have five drug substance manufacturing lines that are in compliance with GMP requirements for microbial fermentation and purification, as well as two fill-finish lines that are automated for cartridges, vials, as well as pre-filled syringes. The available fermentation scales vary from 100L to 500L, 1000L and 2000L. BSL-2 Microbial Development and Manufacturing for vias are 1ml to 25ml, whereas the pre-filled syringes and cartridge filling specifications cover 1-3ml. Our production workshop is cGMP compliant and guarantees steady supply of clinical samples as well as commercial items. Our plant produces large molecules which are shipped to the globe.

• Professionaalsed teadmised ja ulatuslikud kogemused

  Yaohai Bio-Pharma is a leading Microbial biologics CDMO. We have been focused on microbial-produced therapeutics and vaccines for human, veterinary, and the management of pet health. We are equipped with BSL-2 Microbial Development and Manufacturing RD platforms as well as manufacturing technology that encompass the entire process beginning with the development of microbial strains cells, methods and processes, to commercial and clinical manufacturing which ensures successful implementation of cutting-edge solutions. We have acquired a large amount of experience in bio processing of microbial cells. We have delivered over 200 global projects, and help our clients with navigating the laws from the US FDA, EU EMA, Australia TGA, and China NMPA. Our professional expertise and extensive experience allows us to quickly respond to market demands and provide tailored CDMO services.

• Kvaliteedisüsteem ja globaalne regulatiivne vastavus

  BSL-2 Microbial Development and Manufacturing is a Top 10 Microbial CDMO that incorporates quality control and regulatory matters. We have established a robust quality system that complies with the current GMP standards and regulations all over the world. Our regulatory team is well-versed on global regulatory frameworks to speed up biological launches. We guarantee traceable production processes and top-quality products that are compliant with the rules of US FDA, EU EMA, Australia TGA, and China NMPA. Yaohai BioPharma successfully passed an audit on site conducted by an accredited Qualified Person from the European Union (QP) to review our GMP system and production facility. Additionally, we've passed the first certification audits of the ISO9001 Quality Management System, ISO14001 Environmental Management System, and ISO45001 Occupational Health and Safety Management System.

• Kohandamine, tõhusus ja kulutõhusus

  Yaohai Bio-Pharma is experienced in biologicals derived from microbial sources. We provide customized RD solutions and manufacturing, while minimising potential risks. We have worked on various modalities, including recombinant subunit vaccines, peptides hormones, cytokines growth factors, single-domain antibodies enzymes, plasmid DNA various mRNAs, and more. We have specialized in multiple microorganisms, including BSL-2 Microbial Development and Manufacturing intracellular and extracellular secretion (yields up to 15g/L) and intracellular soluble bacteria and inclusion body (yields up to 10g/L). We have also established a BSL-2 fermentation platform to create bacteria-based vaccines. We are experts in improving processes, boosting product yields, and decreasing production costs. We have a highly efficient technology team that ensures timely and top-quality project delivery. This allows us to bring your unique products faster to market.

Seotud tootekategooriad

• Bakteriofaagi AP205 VLP tootmine
• Bakteriofaagi Q VLP tootmine
• Kimäärse VLP vaktsiini tootmine
• Konjugeeritud VLP vaktsiinide tootmine
• DNA vaktsiini tootmine
• E. coli fermentatsioon VLP tootmiseks
• GLP-1 agonisti tootmine
• GLP-1 analoogtootmine
• GLP-1 fragmentide tootmine
• GLP-1 mutatsiooni tootmine

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