ScinoPharm
A One-Stop Shop CMO Service Provider

In the current scenario, demand for manufacturing expertise increases as the generic drug industry faces headwinds like stringent regulatory changes and price erosion. There is a recognized need for expert guidance, particularly for end-to-end continuous manufacturing of small molecule active pharmaceutical ingredients (APIs). While demand for complex APIs increases—more firms are choosing to outsource their development and manufacturing. That said, contract manufacturers are at the centre of the transformation that reshapes the pharmaceutical and biotech industry. Furthermore, the outbreak of the COVID-19 pandemic has favourably impacted the market as many nations have been continuously making microinterventions to speed up certification for third-party sources and ramp-up domestic production to keep supply chains functional. However, owing to the variety of new compounds entering the pipeline, lack of internal capability, and capacity constraints—CMOs need to provide a range of services to help companies overcome price erosion and improve bottom-line. In this regard, ScinoPharm strives to smoothly support its customers through this challenging process and help them benefit from the industry expertise it has accumulated over the span of two decades. The global manufacturer provides a wide array of process R&D services and API manufacturing capabilities designed to satisfy customers’ requirements and facilitate their rapid market introduction with speed and flexibility. In addition to cGMP manufacture of materials for clinical trials, ScinoPharm assures on-time development of noninfringing patent processes from the earliest stage of synthesizing potential NCE’s through large-scale commercial operation. “ScinoPharm offers dedicated, fast-responding contract research organization (CRO) and contract manufacturing organization (CMO) services with analytical and regulatory support to our customers,” states Dr. Portia Lin, Vice-President of Marketing at ScinoPharm.

As a specialist developer and producer of highly potent oncological APIs, ScinoPharm established a firm foothold by focusing on APIs’ manufacturing with high-tech barriers. The in-depth international regulatory and pharmaceutical experience of ScinoPharm’s senior executives has enabled them to create an API business environment similar to large multinational corporations. Its dedicated production facilities located in the Southern Taiwan Science Park complied with FDA and international GMP standards is equipped with advanced process monitoring systems to perform highly automated CGMP production operations cost-effectively. In addition to anti-cancer APIs, ScinoPharm also produces a wide variety of other products, including CNS APIs, gastrointestinal APIs, organic synthesis of small molecules and peptides.

ScinoPharm offers dedicated, fast-responding contract research organization (CRO) and contract manufacturing organization (CMO) services with analytical and regulatory support to our customers

In terms of product development— the company’s seasoned team of professionals, with R&D experts from Taiwan and China, together with its FDA-approved, state-of-the-art CGMP facilities, ensures rapid development and manufacturing of high quality, price competitive, and non-patent infringing APIs to customers. “As our focus is on developing proprietary products and their unique production processes, we strive to pursue an active patent application strategy to maintain our competitive edge,” explains Dr Lin. ScinoPharm actively builds independent intellectual property rights through its patents for its innovative products and techniques designed in the course of R&D activities, thus reinforcing international competitiveness. The company also ensures data integrity by utilizing the TotalFile Guard system to provide higher security/protection of data to control access to product insights and prevent data falsification. Furthermore, to ensure product quality, efficacy, and safety of drug users, products throughout each stage of development have state-of-the-art monitoring systems and waste treatment equipment for consistently conducting safety inspections and audits.

Looking ahead, in the face of the continued impact of the pandemic and the rapidly evolving industry, ScinoPharm will strive to enhance its technical capability while also maintaining its admirable quality and compliance track record to provide the best service to customers. For the first time last year, ScinoPharm’s Changshu plant underwent an onsite inspection by the China National Medical Products Administration for food and drug registration and the China GMP compliance inspection for two items. Once the marketing license has been obtained, ScinoPharm will carry out a large-scale commercial production as it is expected to become one of the Changshu plant’s knock-out products in the future. The company has also recently entered injectable products to provide customers with one-stop services using its vertically integrated structure from APIs to injectable formulations development services for liquid formulations in vials, cartridges, and pre-filled syringes or lyophilized formulations. ScinoPharm’s formulation development laboratory can handle high-potency drugs and has the R&D capabilities to facilitate drug registration. The firm’s formulation development team comprises experts with professional knowledge in formulation development, analytical method development, lyophilization cycle optimization, and process scaleup for NDA and ANDA dossiers. ScinoPharm is also focusing on the injectables CDMO business，, especially combination injectable products.

However, setting up an injectable oncology drugs plant in Taiwan is just the beginning of its strategy to consolidate and expand existing API business for a competitive advantage. “We will continue to strengthen the foundation of stable operations, seize the opportunities from demands of the global pharmaceutical market and abide by industrial regulations and quality standards, to improve corporate profitability of our shareholders, customers and colleagues,” concludes Dr. Lin.