Formosa Laboratories, Inc.: End-to-End Pharmaceutical Ingredient Manufacturing

In the past few years, the generic drugs market has been witnessing rapid growth. The reason behind this immense growth is due to low-end market prices of generic drugs over branded or super generic drugs. However, extensive competition among generic drug developers to win this low-cost market is a growing challenge that is prompting them to partner with contract manufacturing organizations. Not only would such collaborations help drug makers in efficient and timely delivery of services and products but also support them in fulfilling healthcare insurance systems requirements and contracts with hospitals. Taiwan-based Formosa Laboratories is uniquely positioned to offer contract manufacturing organization (CDMO) services extending from Active Pharmaceutical Ingredient (APIs) and Antibody Drug Conjugates (ADCs) to cytotoxic and non-cytotoxic injectables of aseptic liquid filling and lyophilization. Established in 1995, the company initially offered API development with Good Manufacturing Practices (GMP) compliance from regulatory authorities worldwide. Over the years, it gradually extended its services to include CDMO for API formulation development, lyophilization, and injectable manufacturing.
Building on their professionalism and indepth analytical expertise, and experiences in API development, the company streamlines formulation development and manufacturing timeline for drug submission by achieving parallel API and finished product development. “We are dedicated to developing cost-effective manufacturing processes and carrying out highly efficient procurement management to supply quality products that support our clients’ market presence or commence new market entries,” mentions 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.

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-ofthe- art injectable facility.
Another specialty of 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 stateof- 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 onschedule 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 difficultto- make cytotoxic and non-cytotoxic unique APIs and their injectable formulation products,” concludes Dr. Cheng.