CMC Capabilities

Manufacturing

API Manufacturing Services

Our CGMP API manufacturing facilities in Taiwan & Changshu, China share same quality system with proven record of inspections from the US FDA, Japan PMDA, and other health authorities. Both quality and professional services are globally recognized and trusted by our partners. ScinoPharm specializes in the development and manufacturing of high-potency APIs (cytotoxics, steroids, and peptides; OEL < 0.1 µg/m³) and servers customers worldwide. We stand as your reliable partner and provide solution for pharmaceutical research, process development and scale-up, preclinical/clinical manufacturing, commercial production, cost efficiency and continuous improvement. ScinoPharm’s API plant has 18 CGMP-compliant production lines with modern reactors ranging from 20 L to 10,000 L, which can manufacture batches from a few grams to metric ton scale. Each production line has its own dedicated filtering, drying, micronization, and packaging equipment. In addition, with combining multiple peptide synthesis technology (LPPS, SPPS, PEG platform, Segment condensation, and Co-polymer), tangential flow filtration, and column chromatography purification technology (DAC and MCSPG), ScinoPharm is able to rapidly develop peptide products with high stereoselectivity and high yield. The production capacity is up to 200 kg per year.

Injectable Manufacturing Services

ScinoPharm drug product production utilizes a fully enclosed isolation system and automated filling equipment. To reduce the cross-contamination risks associated with cleaning, single-use systems are employed for sterile filtration, transfer tubing and temporary storage bags for compounding solution and aseptic filling. The plant currently features two independent production lines: 1. One line is capable of manufacturing high-potency injectable products in pre-filled syringes and cartridges, boasting a maximum capacity of 7,800 units per hour (uph) for 1 mL products. 2. The second is a vial production line equipped with a 10 m2 freeze-dryer (lyophilizer). This line can fill vials ranging from 10R to 100H in size. The maximum batch size for 10R ISO vials is approximately 19,000 units. This facility can leverage the advantages of the upstream ScinoPharm API plant in oncological Active Pharmaceutical Ingredients (APIs) to produce cytotoxic liquid or lyophilized vials. Once filling is complete, the products are routed to an automatic assembly/packaging line to finalize the finished product packaging according to the product type. The facility is capable of providing comprehensive, customized manufacturing processes based on the specific characteristics of the client's product, making it suitable for injectable products that have high technical barriers.

R&D Technology

API R&D

The API R&D team at ScinoPharm Taiwan consists of over 100 scientists and researchers that are highly qualified and experienced in API synthesis, process development, and analytical characterization. Over 80% of the R&D team holds a Master’s or PhD degree. Their experience, expertise, and dedication in delivering quality makes them one of the most experienced and highly respected R&D teams within the pharmaceutical industries in Taiwan.

Besides the ScinoPharm R&D Headquarters located in Southern Taiwan Science Park, there is a R&D facility at SciAnda (Changshu) Pharmaceuticals) located in Changshu city in the Jiangsu province of China, and a R&D laboratory located in Taipei within the Nangang National Biotechnology Research Park. The overall arrangement of these R&D facilities allow for strategic leveraging and cross-strait advantages ensuring the rapid and consistent recruitment of talent.

The API R&D team at ScinoPharm Taiwan has positioned itself as a leader in the synthesis and manufacturing of APIs used in anti-cancer drugs, and is the unparalleled leader in the kilogram-scale GMP production of peptide drugs. We are continuously thriving to expand and strengthen our CDMO (Contract Development & Manufacturing Organization) capacity and capabilities. This allows us to provide our clients with horizontally integrated services such as process development, scale-up, and support for drug registration applications.

Our API R&D focuses on the development and manufacturing of a diverse range APIs that are used in an array of drugs that include cytotoxic anti-cancer drugs, central nervous system drugs, antiviral drugs, steroid drugs, peptide drugs, and polymer compounds. In addition, supported by our pharmaceutical development capabilities, ScinoPharm is able to formulate injectable drug dosage forms, manufacture injectable products, and supply commercial options—all at the same site. This integration enables ScinoPharm to offer customers a comprehensive, one-stop, vertical service solution.

(INJ) Formulation R&D

Our core capabilities in R&D formulation and process development are based on our vast experience and expertise in generic drug development for a variety of sterile parenteral dosage forms. Through leveraging our capabilities and diverse knowledge in injectables, we are continuing to expand into contract drug development and manufacturing operations (CDMO). Our core capability in generic drug formulation and process development is focused on liquid and lyophilized drug development in different container-closure systems including vials, cartridges, and syringes. ScinoPharm’s Formulation R&D team have established themselves as leaders and experts in lyophilization that ranges from formulation optimization, bulk solution freeze-thaw and thermal characterization studies, cycle development, cycle transfer and scale-up, and regulatory compliance. In addition, our labs are well equipped to perform extensive physicochemical characterization of lyophilized drug product to support CMC regulatory requirements.

Furthermore, we have vast experience in the formulation and process development of combination products that include container-closure evaluation, compatibility and performance attributes. In addition, we are continuing to collaborate and grow our network of pen injector and auto-injector supply chains.

Our vast knowledge, experience, and commitment to quality in injectable drug development has allowed us to achieve and ultimately result in the approval and commercialization of generic drugs in the US and EU markets.In the field of contract drug development and manufacturing, we can offer services that include drug product formulation and process development, lyophilization cycle development, drug product manufacturing, drug product technical transfer from the laboratory stage to full-scale commercial production, and regulatory filing support.

Due to our expertise with peptide APIs, peptide drug products our contract development business places an emphasis primarily on these type of drugs. We can leverage our vast experience in peptide formulation, peptide stability, and extensive physicochemical characterization studies required for these types of products in order to facilitate regulatory filing and approval. Our facility is fully capable of performing all the testing needed in-house.
We also have the capability in the handling and manufacturing of highly potent and cytotoxic compounds utilizing isolation technology, dedicated equipment, and single-use disposable equipment.With our proficiency in technology transfer whether within our facility, or from other site, or from lab-scale to commercial scale, we are well positioned to ensure high quality, efficiency, and in a timely manner when introducing products to market.

Understanding the need and trend for the pharmaceutical industry drive towards the development of more advanced, complex, and effective drug delivery platforms, ScinoPharm’s Formulation R&D team has invested more time, lab equipment, capital, and resources committed to the development for these type of products that include specialized delivery of nanoparticles and combination drug technology.

Building on our Formulation R&D team’s expertise, core capabilities, adherence to quality, allows our company to adopt a strategic advantage of vertical integration between API production and drug product manufacturing to enhance regulatory CMC collaboration and support. Therefore, we can offer clients with one-stop services from API manufacturing through regulatory submission and commercial approval, demonstrating our firm commitment to a global strategic presence.