GMP Plasmid DNA Manufacturing

• Achieving Quality Assurance through GMP in Plasmid DNA Production

  For an even better experience well, dogs living together in the same space and get everything else dialed will accomplish this on top of “whiz-bang-slam-homerun”. A: If you make plasmids to GMP standards, then no matter who makes them, at least the steps and tools are right. This inspection supports them to avert the mistake that may consume time or cause misunderstanding in next steps. GMPs make the process of producing plasmids much more predictable and easier, enabling manufacturers to focus on creating top quality products.

• Streamlining Process Control with GMP in Plasmid DNA Manufacturing

  There are not too many steps that manufacturers must adhere to while preparing plasmids and simply taking a step from GMP guideline. These key steps include:

• Key Approaches to Best Practice GMP in Plasmid DNA Production

  Strictly following the GMP rules for plasmid DNA production is important and these steps are key in doing so. It provides the foundation upon which they can create human-safe and effective plasmids.

Why choose Yaohai GMP Plasmid DNA Manufacturing?

• Customization, Efficiency & Cost-Effectiveness

  Yaohai Bio-Pharma is GMP Plasmid DNA Manufacturing in microbial-derived biologics. We offer custom RD as well as manufacturing solutions, while minimising the risk. We've been involved in numerous modalities like recombinant subunit vaccines, peptides hormones, cytokines growth factors, single-domain antibodies, enzymes, plasmid DNA, the mRNA, and other. We are experts in several Microbial hosts, such as yeast extracellular and intracellular (yield up to 15 grams per liter) bacteria periplasmic secretion as well as soluble intracellular inclusion bodies (yield up to 10 grams/L). Additionally, we have developed the BSL-2 microbial fermentation platform for the development of bacterial vaccines. We have a track record of improving production processes, thereby increasing yields, and reducing costs. With a highly efficient technology team, we guarantee prompt and reliable project delivery and bring your products to market quicker.

• Robust Supply Chain & Manufacturing Capabilities

  Yaohai Bio-Pharma, a top 10 producer of GMP Plasmid DNA Manufacturing, specializes in microbial fermentation. We have set up a modern facility with advanced facilities as well as robust RD manufacturing capabilities. Five production lines for drug substances complying with GMP standards for microbial purification and ferment along with two automated fill and finish lines for vials as well as cartridges as well as pre-filled needles are readily available. The available fermentation scales range between 100L and 2000L. Vial filling specifications cover 1ml - 25ml. the pre-filled cartridge or syringe filling specifications are between 1-3ml. The production workshop is cGMP certified and offers the availability of commercial and clinical samples. Our plant produces big molecules that are exported to all over the world.

• Professional Expertise & Extensive Experience

  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 GMP Plasmid DNA 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.

• Quality System & Global Regulatory Compliance

  Yaohai BioPharma, a GMP Plasmid DNA Manufacturing Microbial CDMO, integrates regulatory affairs and quality management. We have a quality system that is compliant with current GMP standards, as well as regulations around the globe. Our regulatory team is knowledgeable in global regulatory frameworks to expedite biological launches. We make sure that production processes are traceable, high-quality products, and complying with the rules of the US FDA and EU EMA. Australia TGA and China NMPA is also fulfilled. Yaohai BioPharma has successfully passed the audit on site of the European Union's Qualified Person (QP) to ensure our GMP quality system and production site. We also have passed the initial certification audits of the ISO9001 Quality Management System and ISO14001 Environmental Management System.

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