Circular RNA, or circRNA, is a specific kind of RNA that has a different shape. Whereas normal RNA has a linear straight-line appearance, circRNA is looped. CircRNAs — a type whose structure is crucial because they usually turn out to be abundant and participate in a lot of important cellular processes. For one thing, they regulate how our genes are expressed, which can influence everything from our body’s growth patterns to how we respond to disease. CircRNAs are of great interest to scientists; better understanding of them can reveal how diseases develop and identify novel therapeutic approaches. But there is a problem: circRNAs are very small and tend to be present in very low quantities in the samples scientists study. This makes it challenging to harvest enough circRNA for research.
Before the definitive foundation was established to collect circRNA, a well-established method called High-performance liquid chromatography, or HPLC in brief, was utilized. HPLC is a versatile technique used for separating various molecules according to their physical and chemical characteristics. It operates by separating molecules based on size and shape. Because circRNAs are very small, they can be easily lost amid the thousands of other molecules in a sample. It means circRNAs can be separated out from other RNAs, proteins and exogenous debris that may have been included in the sample by using effective methods such as size exclusion chromatography (SEC), a HPLC technique. It's an important separation for scientists who need to isolate the circRNA for their research.
Once HPLC assists in purification of circRNA, it must be analysed thoroughly by scientists to understand its functions in us. CircRNAs emerged as important molecules involved in multiple biological functions, making a thorough understanding of the various circRNA types and roles critical for deciphering their involvement in diverse diseases. Scientists do not know the sequence of the purified circRNA and will need to in order to discover the functions of these roles. For this, they utilize techniques such as reverse transcription PCR (RT-PCR). With RT-PCR, scientists make additional copies of the circRNA so that they can study it more specifically. They are often informative, providing information on how these molecules function and what they do in our cells, by analyzing the circRNA sequences.
Researchers need to recover all the circRNA they can get their hands on. CircRNAs are only available in small quantities in biological specimens, and HPLC can be helpful for separating and collecting a larger amount of these critical molecules. So researchers have a greater likelihood of obtaining enough circRNA for their experiments, and generating actionable findings. The more circRNA they can collect, the more functions and roles they can learn about in health and disease.
Methods for circRNA extraction from complex biological materials are often high-cost (e.g., ultrafiltration), tedious, and prone to contamination. Getting the circRNA out without losing any often takes some careful handling and multiple steps. This is where HPLC is really useful. HPLC methods can make the extraction more rapid and effective process. By reducing the steps in extraction, HPLC also minimizes potential loss of valuable samples. This careful method produces more reliable data and helps ensure that the isolated circRNA is as pure as possible.
CircRNAs are very difficult to study, and it relies on scientists being extra precise in their identification and measurement. Based on this factor, HPLC not only is a key step to removing other contaminants but also guarantees that only circRNA molecules can be isolated, improving the specificity and sensitivity of circRNA detection. This results in a cleaner sample, which is important for research accuracy. Having a purified sample of circRNA helps scientists have more confidence in their results and have a lesser chance to making mistakes in their studies.
Yaohai Bio-Pharma is a Top 10 biological company that specializes in HPLC-based circRNA Purification. We have built a modern manufacturing facility with robust RD capabilities and modern manufacturing facilities. Five drug substance production lines complying with GMP standards for microbial fermentation and purification along with two fill and final lines for vials and cartridges as well as pre-filled needles are readily available. The available fermentation scales vary between 100L and 2000L. The filling volume ranges from 1ml up to 25ml. Syringes or cartridges that are pre-filled are filled with 3 to 3.5ml. Our production workshop that is cGMP-compliant ensures constant supply of clinical sample and commercial products. Our facility produces large molecules that are exported to all over the world.
Yaohai Bio-Pharma, a leader in HPLC-based circRNA Purification of microbial biologics, is located in Jiangsu. We are focusing on microbially produced therapeutics and vaccines that are suited for human, veterinary, and pet health management. We have modern RD as well as manufacturing technology platforms that cover the entire process, from engineering microbial strains, cell banking, process and method development, through to commercial and clinical manufacturing, making sure that we can ensure the successful supply of the most cutting-edge solutions. We have acquired a large amount of experience in the microbial bio processing field. More than 200 projects have been completed successfully and we support our clients in overcome regulations such as those of the US FDA and EU EMA. We also aid them with Australia TGA and China NMPA. We are able to respond rapidly to market requirements and offer customized CDMO services thanks to our experience and expertise.
Yaohai Bio-Pharma is HPLC-based circRNA Purification 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.
Yaohai BioPharma, a top 10 Microbial CDMO that integrates quality management and regulatory affairs. Our quality system that is compliant with current GMP standards as well as international regulations. Our team of regulatory experts is proficient in global regulatory frameworks to accelerate biological launches. We ensure traceable production procedures quality products, as well as conformity with the requirements of the HPLC-based circRNA Purification and EU EMA. Australia TGA and China NMPA are also met. Yaohai BioPharma successfully passed an in-person audit conducted by a Qualified Person of the European Union (QP) to examine our GMP system and production facility. We also completed the initial certification audits of the ISO9001 Quality Management System and ISO14001 Environmental Management System.