Pengembangan dan Pembuatan DNA Minicircle Indonesia

• Kemajuan dalam Pengembangan DNA Minicircle untuk Aplikasi Biomedis

  Penggantian bagian yang cedera merupakan aspek penting lainnya. Ini disebut obat regeneratif. Pemulihan/penyembuhan bagian tubuh yang terluka atau sakit adalah tanggung jawab mereka, dan obat-obatan regeneratif menghambat pemulihan tersebut. Para peneliti menggunakan DNA lingkaran mini sebagai bagian dari terapi baru yang ditujukan untuk kondisi seperti penyakit jantung, gangguan hati, dan berbagai masalah kesehatan lainnya.

• Produksi DNA Minicircle yang Efisien untuk Uji Klinis

  Masyarakat harus terlebih dahulu menguji pengobatan baru dengan menggunakan uji klinis sebelum tersedia. Uji klinis adalah studi penelitian yang menyelidiki apakah pengobatan yang digunakan dalam penelitian aman dan seberapa baik cara kerjanya. Uji klinis semacam itu sering kali melibatkan ratusan pasien dan dapat berlangsung bertahun-tahun. Ini merupakan langkah penting untuk memastikan bahwa pengobatan aman bagi semua orang.

• Manufaktur DNA Minicircle yang Efisien untuk Terapi yang Terjangkau

  Menghasilkan DNA lingkaran kecil dalam jumlah yang cukup untuk setiap pengujian dalam uji klinis adalah salah satu alasan mengapa pendekatan ini menghadirkan tantangan. Untungnya, para ilmuwan menemukan cara inovatif untuk menyederhanakan proses tersebut. Akibatnya, mereka mencoba menemukan cara baru untuk menghasilkan DNA lingkaran kecil dengan lebih cepat dan lebih baik. Mewujudkan hal ini akan mengurangi biaya dan jangka waktu pengujian, namun yang lebih penting, hal ini akan membuat pengobatan baru tersedia bagi pasien dengan lebih cepat dan hal ini merupakan hal yang baik ketika sebagian orang merasa putus asa.

Mengapa memilih Pengembangan dan Manufaktur DNA Minicircle Yaohai?

• Sistem Mutu & Kepatuhan Terhadap Peraturan Global

  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.

• Keahlian Profesional & Pengalaman Luas

  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.

• Rantai Pasokan & Kemampuan Manufaktur yang Kuat

  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.

• Kustomisasi, Efisiensi & Efektivitas Biaya

  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.

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