ミニサークルDNAの開発と製造 日本

• バイオメディカル用途向けミニサークル DNA 開発の進歩

  損傷した部分の交換も重要な側面です。これらは再生医療と呼ばれます。身体の損傷または病変部分の回復/治癒は再生医療に必須であり、再生医療はそのような回復を阻害します。研究者は、心臓病、肝臓障害、その他多くの健康問題などの症状を対象とした新しい治療法の一部としてミニサークル DNA を使用しています。

• 臨床試験のための合理化されたミニサークル DNA 生成

  新しい治療法が利用可能になる前に、まず臨床試験を行ってその治療法をテストする必要があります。臨床試験とは、研究目的の治療が安全かどうか、またどの程度効果があるかを調べる調査研究です。このような臨床試験では、数百人の患者が対象になることが多く、何年もかかることがあります。これは、治療がすべての人にとって安全であることを確認するための重要なステップです。

• 手頃な価格の治療薬のための効率的なミニサークル DNA 製造

  臨床試験の各テストに十分な量のミニサークル DNA を生成することが、このアプローチが課題である理由の 1 つです。ありがたいことに、科学者たちはプロセスを効率化する革新的な方法を考案しています。実際、科学者たちはミニサークル DNA をより速く、より良く生成する新しい方法を見つけようとしています。これが実現すれば、テストのコストと期間が削減されるはずですが、さらに重要なのは、新しい治療法がより早く患者に提供されるようになることです。これは、一部の人々が切実に望んでいる状況では良いことです。

Yaohai Minicircle DNA 開発製造を選ぶ理由は何ですか?

• 品質システムとグローバル規制コンプライアンス

  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.

• 専門知識と豊富な経験

  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.

• 強力なサプライチェーンと製造能力

  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.

• カスタマイズ、効率性、コスト効率

  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.

関連商品カテゴリー

探しているものが見つかりませんか?
その他の利用可能な製品については、コンサルタントにお問い合わせください。