Minicircle DNA Development and Manufacturing

• Advancements in Minicircle DNA Development for Biomedical Applications

  Replacement of injured parts is another crucial aspect. These are called regenerative medicines. Recovering/ Healing of the injured or diseased part(s) of body isentailedon them, and regenerativemedicine provides inhibits such recovery. Researchers are using minicircle DNA as part of new therapies aimed at conditions such heart disease, liver disorders and numerous other health issues.

• Streamlined Minicircle DNA Production for Clinical Trials

  People must first test new treatments by using clinical trials before they are available. Clinical trials are research studies which investigate if treatments on investigational use are safe and how well they work. Such clinical trials often use hundreds of patients and can last years. This is an important step in making sure that treatments are safe for everyone.

• Efficient Minicircle DNA Manufacturing for Affordable Therapeutics

  Producing adequate amounts of minicircle DNA for each test in clinical trials is one reason why the approach presents a challenge. Thankfully, scientists are coming up with innovative ways to streamline the process. In effect, they are trying to find new ways to produce minicircle DNA faster and better. Enabling this to happen should reduce costs and timeframes for testing but more importantly, it will get new treatments availableto patients faster which has got to be a good thing where some people are desperate.

Why choose Yaohai Minicircle DNA Development and Manufacturing?

• Quality System & Global Regulatory Compliance

  Yaohai BioPharma is a Top 10 Microbial CDMO that incorporates Minicircle DNA Development and Manufacturing as well as regulatory affairs. We have a quality management system which is in line with current GMP standards as well as global regulations. Our team of regulatory experts is proficient in global regulatory frameworks to accelerate biological launches. We ensure traceable production processes quality products, as well as complying with the rules of the US FDA and EU EMA. Australia TGA and China NMPA are also satisfied. Yaohai BioPharma has successfully passed the audit on site of the European Union's Qualified Person (QP) for our GMP quality system as well as our production facility. Furthermore, we have cleared the first certification audits of the ISO9001 Quality Management System, ISO14001 Environmental Management System, and ISO45001 Occupational Health and Safety Management System.

• 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 Minicircle DNA 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.

• Robust Supply Chain & Manufacturing Capabilities

  Yaohai Bio-Pharma, a top 10 Minicircle DNA Development and 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.

• Customization, Efficiency & Cost-Effectiveness

  Yaohai Bio-Pharma has experience in the production of biologics created from Minicircle DNA Development and Manufacturing. We offer customized RD and manufacturing solutions while making sure that there are no risks. We have been involved in diverse modalities such as subunit vaccines recombinant, peptides hormones, cytokines, growth factors, single-domain antibodies enzymes, plasmid DNA MRNA, and many more. We are a specialist in many microorganisms, including yeast extracellular and intracellular secretion (yields up to 15g/L) as well as bacteria intracellular soluble and inclusion body (yields as high as 10g/L). We have also created a BSL-2 fermentation platform to create bacterial vaccines. We focus on improving processes, increasing product yields, and reducing production costs. Utilizing a strong technology team, we can ensure prompt and reliable project delivery that will bring your product to market faster.

Related product categories

Not finding what you're looking for?
Contact our consultants for more available products.