Huiyu is an innovation driven pharmaceutical company with primary strategic focus on the regulatory market, the company specializes in R&D and manufacturing of innovative APIs, generic APIs and advanced intermediates, and also provides API CMO services with dangerous reaction capabilities including hydrogenation, oxidation, as well as capability of high pressure, high temperature, cryogenic reaction conditions. Pressure range: 0~5MPa, temperature range: -55 ℃~220℃. 

Huiyu Pharma offers seamless High Potent PAPI scalability from lab scale to 10,000 Liter scales to support feasibility, clinical trial material manufacture and commercial production. We have an experienced workforce and capabilities across our network to help client meet regulatory as well as Environment, Health and Safety (EHS) requirements. Our development and manufacturing site network is routinely inspected by global regulatory authorities including US FDA, EMA, MHRA, etc.

ADCs / bioconjugates pose a complex challenge from a development and manufacturing perspective. Huiyu Pharma offers a complete end to end solution that simplifies the value chain and accelerates the timeline to the clinic or the market.

Manufacturing Process

Benefit from years of experience in drug substance manufacturing across a broad spectrum of both platform and novel conjugation technologies. We can help client commercialize drug candidate. We have a successful track record in process design and the execution of validation/conformance batches to support PAI, launch, and commercial manufacturing requirements:

• √ Different GMP scales to produce flexible batch scales between grams and kilograms
• √ Qualified stainless steel and single-use equipment
• √ Aseptic biopharmaceutical manufacturing environment
• √ cGMP facilities with safety procedures in place to handle cytotoxic compounds with OEL down to 1 ng/m3
• √ GMP facilities successfully inspected to deliver Bioconjugates Products into different countries globally

mRNA drug substance production is a cell-free process that involves linearization of plasmid DNA(pDNA), mixing it with enzymes and nucleotides to allow for its transcription into mRNA, and mRNA capping, etc.
Manufacturing
mRNA production begins with in-vitro transcription, where the linearized pDNA is synthesized to form mRNA in a reactor. Then, the mRNA is purified in steps involving chromatography and ultrafiltration (UF)/diafiltration (DF) to prepare for the formulation stage. Finally, the purified mRNA is encapsulated into Lipid Nanoparticles (LNP) through precise pump mixing technology to prevent degradation and to allow for in vivo delivery.
Storage 
Because mRNA is susceptible to degradation upon changing temperatures, it is subject to strict storage conditions. Huiyu Pharma is able to meet such challenges through its upright and walk-in storage systems with temperatures as low as -70°C as needed.