Pengembangan Proses Antibodi Domain Tunggal (sdAb) Indonesia

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  Metode pemilihan sdAb baru untuk meningkatkan spesifisitas

  Yaohai dan timnya telah menciptakan beberapa metode yang sangat tepat untuk menyaring sdAb. Metode ini tidak hanya sangat spesifik, tetapi yang lebih penting lagi, metode ini membantu mereka memastikan keamanan sdAb dengan memahami apa yang akan dan tidak akan menjadi target dalam tubuh seseorang. Produksi VHH Anti-EGFR GMP akan memastikan bahwa obat tersebut aman dan efektif bagi semua orang yang membutuhkannya.  

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  Memfasilitasi ekspresi sdAb dalam berbagai sistem host

  Mereka bahkan mencari jenis sel yang dapat menghasilkan sdAb lebih baik daripada hasil penyaringan aslinya. Hal ini membantu mereka mengembangkan lebih banyak sdAb yang dapat berfungsi secara efisien di bidang yang ditargetkan. Hal ini akan menambah keragaman sel yang dapat mereka saring untuk produksi sdAb dan meningkatkan generasi fusi mereka untuk menghasilkan sdAb yang lebih efektif. 

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  Kemajuan dalam formulasi sdAb untuk meningkatkan stabilitas dan umur simpan

  Berapa lama obat itu bertahan? Lalu, apa yang bisa dilakukan orang yang bekerja dengan Anda untuk membuatnya sangat stabil sehingga obat itu juga memiliki masa simpan yang lama. Yang terpenting, obat itu disimpan di tempat yang tetap efektif untuk jangka waktu yang lebih lama. Dan menjaga Produksi VHH Anti-HER3 GMP disimpan dengan sangat hati-hati berarti lebih banyak orang bisa mendapatkan obat tersebut tanpa khawatir obat tersebut tidak lagi berfungsi.  

Mengapa memilih Pengembangan Proses Antibodi Domain Tunggal Yaohai (sdAb)?

• Keahlian Profesional & Pengalaman Luas

  Single Domain Antibody (sdAb) Process Development is a leading in microbial biologics CDMO. Our focus has been on microbial-produced vaccines and therapeutics that are suited for human, veterinary, as well as pet health management. We have the most cutting-edge RD platforms and manufacturing technology which cover the entire procedure beginning with the development of microbial strains and cell banking, to process and method development, to commercial and clinical production which ensures successful delivery of innovative solutions. Over time, we have accumulated vast knowledge of microbial-based bio processing. Over 200 projects have been successfully completed, and we assist our clients to comply with regulations like those of US FDA and EU EMA. We also help them to navigate Australia TGA and China NMPA. Our professional expertise and extensive experience allows us to quickly respond to market demands and provide bespoke CDMO services.

• Sistem Mutu & Kepatuhan Terhadap Peraturan Global

  Yaohai BioPharma is a Top 10 Microbial CDMO that incorporates quality management and regulatory issues. We have developed a solid quality management system that conforms to the current GMP standards and regulations globally. Our regulatory team has an in-depth understanding of the world-wide regulatory frameworks. This allows us to accelerate biological launches. We ensure traceable production processes as well as high-quality products and in compliance with the guidelines of the US FDA and EU EMA. Single Domain Antibody (sdAb) Process Development and China NMPA are also satisfied. Yaohai BioPharma successfully passed an on-site audit conducted by an accredited Qualified Person of the European Union (QP) to review our GMP system and production facility. We have also been through the first certification audits of the ISO9001 Quality Management System and ISO14001 Environmental Management System.

• Kustomisasi, Efisiensi & Efektivitas Biaya

  Yaohai Bio-Pharma is Single Domain Antibody (sdAb) Process Development 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.

• Rantai Pasokan & Kemampuan Manufaktur yang Kuat

  Yaohai Bio-Pharma, a Single Domain Antibody (sdAb) Process Development manufacturer of biological products, is a specialist in microbial fermentations. We have built a modern factory equipped with modern facilities and strong RD and manufacturing capabilities. Five drug substance production lines that are compliant with GMP standards for microbial purification and ferment, as well as two fill and finish lines for vials as well as cartridges, as well as needles that are pre-filled, are readily available. The available fermentation scales vary from 100L to 500L, 1000L, to 2000L. Filling volumes vary from 1ml to 25ml. Syringes or cartridges pre-filled are filled with the equivalent of 1-3ml. Our cGMP-compliant production facility ensures the availability of stable clinical samples and commercial products. The big molecules that are produced at our plant are readily available for international delivery.

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