Technology

Injection Manufacturing

Injectable Formulation

SPERA PHARMA, Inc. leverages the extensive experience gained from research and development at the country’s largest pharmaceutical company to provide high-value-added injectable formulations, characterized by speed, cost-effectiveness, and global applicability. From early to mid-stage development, we provide manufacturing services for clinical trial drugs.
In September 2023, our group company, Iwaki Seiyaku Sakura Factory Co., Ltd. began the operation of manufacturing lines that handle from early, mid, and late stages of clinical trial drugs to commercial production. This includes highly pharmacologically active (potent) drugs, enabling us to offer seamless services from drug development to commercial manufacturing.
Our company adheres to GMP standards in Japan, the United States, and Europe, as well as PIC/S GMP, guidelines, supporting distribution to the global markets, including these regions and other markets around the world. We have extensive experience and a strong reputation for reliability, having completed numerous contracts for injectable formulations with domestic and international pharmaceutical companies, universities, and venture companies.

Injectable Formulation Study

We offer services for formulation and formulation studies of solution, frozen, and lyophilized formulations. Additionally, we offer initial studies for suspension, emulsion, liposome, and pre-filled syringe formulations. Our extensive experience in analytical method development includes testing methods for small molecules as well as biopharmaceuticals such as protein and peptide products and nucleic acid drugs.
In recent years, there has been an increasing demand for data on the leakage of packaging containers, both domestic and international markets. We offer quantitative test method development and quantitative data acquisition for leak testing (CCIT) using container integrity testers.

Injectable Clinical Trial Drug Manufacturing

We offer services including vial filling, testing, and secondary packaging for injectable drug products, as well as quality testing, specification development, and stability testing for formulations, including biopharmaceuticals. Our scientists from the formulation development, analytical method development, manufacturing, and testing groups will collaborate seamlessly as one team, working on a project at the same site to enable rapid manufacturing process development and immediate resolution of any issues, guaranteeing smooth project delivery.

Overview of Injectable Drug Facilities

At our group company, Iwaki Seiyaku Sakura Factory Co., Ltd. manufacturing lines for clinical trial materials from early- to late-stage development and up to commercialization began operation in September 2023. This allows us to seamlessly provide services from pharmaceutical R&D to commercial manufacturing, including highly potent pharmacal ingredient. Our scientists will play a central role in formulation manufacturing and technology transfer for testing methods at Iwaki Seiyaku Sakura Factory Co., Ltd.

Collaboration between SPERA PHARMA and Iwaki Seiyaku Sakura Factory