GMP sdAb Manufacturing

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  Ensuring Safety and Efficacy with GMP sdAb Production

  Yaohai is well aware that safety and efficacy of our sdAbs are absolutely pivotal. This is why we follow GMP rules during the whole process. And this is how we ensure that our customers get the finest products to fulfil their dreams. We want them to work well and we want our sdAbs to be used, this is why it plays a huge role in achieving that — GMP.

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  Streamlining the Manufacturing Process with GMP Guidelines

  Application of GMP rules helped us greatly in refining the manufacturing process, We have guided our efforts based on these principles from the first reagents we use to the final products we generate, in order to deliver the highest quality sdAbs. This commitment allows us to not only maintain quality, but also speed up the time it takes for us to produce products. We want to ensure that you get your sdAbs shortly and that they maintain highest of standards.

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  Meeting Regulatory Standards with GMP sdAb Manufacturing

  The process of making sdAbs is a rules-based order. GMP ensures our products are manufactured following these fundamental standards for the safe and minimal quality output, consistently. This all-important consistency builds trust with our customers and the auditors who review us. By adhering to these guidelines, we can practice responsible stewardship of our sdAbs and continue to deliver important products for our customers.

Why choose Yaohai GMP sdAb Manufacturing?

• Tvirta tiekimo grandinė ir gamybos galimybės

  Yaohai Bio-Pharma, a top 10 manufacturer of biological products, specializes in microbial fermentation. We have built a modern facility with robust RD capabilities and advanced equipment. We have five drug substance manufacturing lines that conform to GMP requirements for microbial fermentation and purification. We also have two automated fill-finish lines for cartridges, vials and pre-filled syringes. The fermentation scales available for use range from GMP sdAb Manufacturing to 2000L. The specifications for the filling of a vial range from 1ml up to 25ml. pre-filled syringe or cartridge filling specifications range from approximately 1-3ml. Our cGMP-compliant production facility ensures constant supply of clinical sample as well as commercial items. Our plant produces big molecules which are shipped to the globe.

• Kokybės sistema ir visuotinis reguliavimas

  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 GMP sdAb 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.

• Pritaikymas, efektyvumas ir ekonomiškumas

  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 GMP sdAb 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.

• Profesionali patirtis ir didelė patirtis

  Yaohai Bio-Pharma is a leading microbiological CDMO. Our focus has been on microbially produced GMP sdAb Manufacturing 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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