July - Sept 202119BUSINESSMANAGEMENTREVIEW.COMWe are dedicated to developing cost-effective manufacturing process and carrying out highly efficient procurement management to supply quality products that support our clients market presence or commence new market entriesFORMOSA LABORATORIESEND-TO-END PHARMACEUTICAL INGREDIENT MANUFACTURINGmentions Dr. C.Y Cheng, founder of Formosa Laboratories. When such capabilities are combined with the history of supplying non-infringing APIs, Formosa Laboratories emerges as an indisputable API partner to generic companies who aspire to an early entry into the market by Promoting Pediatric Primary Prevention (P4) challenge.Another specialty of Formosa Laboratories' is integrating API manufacturing with injectable products. The firm provides one-stop solutions for sterile injectable drug products and has implemented a comprehensive process control in its state-of-the-art injectable facility. It has set-up a commercial high-speed line to aseptically fill liquid for non-cytotoxic products that reaches 18,000 vials per hour with a 100 percent weight check for in-process control (IPC). Alongside, the auto-loading and unloading system at Formosa Laboratories' facility (ALUS) for lyophilizer enables an efficient manufacturing state when handling complex processes. Even the quick Vaporized Hydrogen Peroxide (VHP) cycle and low hydrogen peroxide residual concentration is advantageous in handling biologic drugs. Moreover, the disposable single-use systems at the facility help reduce contamination risks and streamline process operations for biologic product manufacturing. "Such state-of-the-art facilities enable us to carry out processes under full cGMP conditions with speed, efficiency, exceptional quality, and flexibility and adapt to changes in clients' goals," says Dr. Cheng.For the commendable work carried out by Formosa Laboratories in API development and CDMO, Dr. Cheng credits collaborations with several enterprises. Majorly, the company's partnership with its sister company, EirGenix, which specializes in antibody development and manufacturing, to deliver ADC/API or the ADC/injectable product, takes the lead. This collaboration helped Formosa Laboratories support a European company to successfully develop a difficult ADC and file an Investigational New Drug Application (IND). "The ADC process scaled up to production scale for the client," says Dr. Cheng.Additionally, the firm strategically associates with specialty formulation development companies to manage the production schedule in supply chain management of raw materials and the partnership with vendors. All this results in well-coordinated operations among departments and vendors to ensure on-schedule delivery of goods.Having assisted many clients, Formosa Laboratories is now looking to cater to a larger customer base in the future. The company is expanding its business from small molecules to include large molecules and growing its CDMO service in ADC development through collaboration with EirGenix. In terms of geographic expansion, Formosa Laboratories has moved overseas and set up a sales and BD subsidiary in Japan. "With our strong R&D capability, extensive experience in GMP production, and inception of our modern injectable facilities, we aim to become a first-rate CDMO service provider for difficult-to-make cytotoxic and non-cytotoxic unique APIs and their injectable formulation products," concludes Dr. Cheng. BM
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