Human Insulin Biomanufacturing

• Pioneering Techniques in Human Insulin Biomanufacturing

  The facilities that make insulin have strict rules in addition to quality control procedures, barring for example unsafe practices which would be hazardous not only to human health but the environment. These safety precautions include the use of special tools: wearing protective clothing that helps keep everyone safe is engaged in their work. It is important to ensure that both the people producing insulin and their environment are safeguarded.

• Quality Control and Safety Measures in Human Insulin Biomanufacturing

  One way to address this is by producing something called biosimilar insulin. A biosimilar insulin is similar to the brand name (reference) insulin, but it comes at a cheaper price. Which translates into a higher percentage of the world getting that basic insulin they need, even those in places where there is no money for such things.

• Meeting Global Demand for Affordable Diabetes Treatmen

  But the production of biosimilar insulin is not developed as well. May be it will take more time but efforts have been made in this direction, together with modern ideas on how to reduce even further the cost of making insulin. They give birth to new means of making insulin and are in league with organizations that partner for the distribution of insulins in communities across regions where it is proven highly vital. This is very important work to make certain that all who need insulin are able to afford it without suffering insurmountable financial distress.

Why choose Yaohai Human Insulin Biomanufacturing?

• Professional Expertise & Extensive Experience

  Yaohai Bio-Pharma, a leader in CDMOs for microbial biologics, is located in Jiangsu. We are focusing on microbially produced therapeutics and vaccines that are Human Insulin Biomanufacturing for human, veterinary as well as pet health management. We have the most cutting-edge RD platforms as well as manufacturing technology that cover the entire manufacturing process, from microbial strain development, cell banking, process and method development to clinical and commercial manufacture which ensures successful production of novel solutions. We have gained an extensive amount of experience in bio processing of microbial cells. More than 200 projects have been successfully completed, and we support our clients in get through regulations, such as those of US FDA as well as EU EMA. We also aid them with Australia TGA and China NMPA. Our experience and professional knowledge as well as our extensive knowledge allow us to quickly respond to market demands and provide customized CDMO services.

• Robust Supply Chain & Manufacturing Capabilities

  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. Human Insulin Biomanufacturing 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.

• Customization, Efficiency & Cost-Effectiveness

  Yaohai Bio-Pharma has experience in manufacturing biologics that are created from microorganisms. We offer bespoke RD solutions as well as manufacturing services while minimising potential risks. We have worked with diverse techniques, such as recombinant cellular subunits, vaccines (including peptides), growth factors, hormones, and the Human Insulin Biomanufacturing. We are a specialist in many microorganisms like yeast extracellular and intracellular secretion (yields up to 15g/L) and bacteria intracellular soluble, and inclusion body (yields up to 10g/L). We have also developed a BSL-2 fermentation platform to create bacterial vaccines. We have a track record of improving production processes, thereby increasing yields and reducing costs. We have a highly-efficient technology team to ensure timely and high-quality delivery of projects. This helps us bring your products that are unique faster to the market.

• Quality System & Global Regulatory Compliance

  Yaohai BioPharma, a Human Insulin Biomanufacturing 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.

Related product categories

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