Non-GMP & GMP Manufacturing of APIs

BOC Sciences can provide non-cGMP/cGMP pilot and commercial scale solutions for your APIs. As a global leader in chemical manufacturing solutions, BOC Sciences has experienced employees, large-scale production plants and advanced equipment, which can provide you with excellent results with quality assurance for your projects. From early process optimization and scale-up to commercial production, we provide critical services throughout the lifecycle to bring your project to market.

Active Pharmaceutical Ingredient

The timely, effective, and high-quality research and manufacturing of small-molecule active pharmaceutical ingredients (API) is critical to its success. An active pharmaceutical ingredient (API) is the main active ingredient in a drug that produces the desired effect. It is a key component in treating and preventing diseases and ailments, providing therapeutic benefits. APIs are usually in the form of solid powders, crystals, or granules, and are combined with other substances called excipients to form the drug's final dosage form, such as tablets, capsules, or injections. The main role of an API is to target a specific disease pathway or mechanism in the body to produce a therapeutic effect. APIs can come from natural sources such as plants, animals, or microorganisms. They can also be synthesized in a laboratory through chemical processes. Regardless of their source, APIs must be pure, potent, and stable to ensure the safety and effectiveness of the drug. APIs supported by our CDMO include:

API Manufacturing

Committed to quality and innovation, BOC Sciences offers a wide range of customized CDMO services to meet the specific needs of clients in the pharmaceutical, biotechnology and life science industries. Our experienced team of chemists and scientists works closely with clients to develop efficient and cost-effective API production processes that ensure high purity, quality and regulatory compliance. BOC Sciences is equipped with state-of-the-art facilities and advanced equipment to perform complex chemical synthesis and purification processes, enabling efficient production from laboratory to commercial scale. Our development and manufacturing teams can execute the following:

Kilo Lab Manufacturing

• Our R&D base has multiple kilogram-level laboratories and API D-level clean rooms, which can complete the rapid synthesis of tens of kilograms of APIs.
• In the kilo laboratory stage, the existing process can be modified before further expansion, so as to maximize the success of the pilot scale process.
• We have strong technology transfer capabilities and can implement undifferentiated cGMP scale-up manufacturing after the process in the kilogram laboratory.
• Pre-verify the products from the kilo laboratory to the scaled-up scale, and keep the samples for records after the quality is no problem. A dedicated chemical engineer is responsible for the transfer between processes.
• Write a detailed process specification, and the project manager will give a detailed introduction to the customers. If you think the process needs to be adjusted, we will do it in a kilo laboratory.
• The setting of kilo laboratory can save huge cost for your project. It helps our team to clearly grasp all the information of key steps and process parameters, and to ensure that the subsequent manufacturing process is smoother and more efficient.

Pilot and Commercial Scale Manufacturing

The existence of the amplification effect will make many operations that are easy to implement or errors that are easy to correct under small-scale conditions very complicated, and in severe cases will lead to the failure of the entire project. BOC Sciences focuses on overcoming and solving the weak links of pilot scale-up technology and process, improving quality and efficiency, and further helping customers save R&D and production costs. Our pilot-scale and commercial-scale manufacturing have obtained cGMP compliance certification, and can supply materials for pre-clinical, IND and early clinical trials. Our production workshops have a total area of more than 6000 square feet, with a series of reactors ranging from 50 L to 2000 L, and multiple drug product (DP) filling production lines. Pilot scale up is the only way to enter commercial scale production. During the pilot scale-up, there may be an amplification effect that would not occur in laboratory-scale production.

• Various kinds of manufacturing processes, such as condensation, substitution, acylation, redox, fermentation, low temperature, high pressure and high temperature reactions, etc.
• Manufacturing of APIs conforming to cGMP principles from kilogram to hundred kilograms.
• Production of high value-added intermediates and registered starting materials from kilo to ton.
• Crystallization technology platform provides crystal form screening, crystallization process development and optimization, solid-state screening characterization and chiral separation.
• Offering a wide range of flow chemistry equipment with modular performance that can be configured to your desired chemical reaction to simplify your workflow.
• Providing impurity confirmation, impurity source control and process control, and establishment and verification of impurity analysis methods.

Manufacturing Facilities

BOC Sciences has a C-level pilot plant of 600 square meters and a D-level pilot plant of 200 square meters, as well as a C-level QC testing plant of 100 square meters that meet the requirements of cGMP, with a P2 laboratory qualification for the C-level plant of 80 square meters. There is one sterile filling and formulation production line.

In 2020, BOC Sciences passed the ISO9001 quality system certification and established a quality management system that meets the requirements of drug research and pilot production, including electronic systems for material management, equipment and facility management, and personnel management, in combination with cGMP, GLP and other regulatory requirements.

The scientific and flexible flow line design can not only meet the manufacturing of various types of reactions, but also reduce cross-contamination in the manufacturing process, and ensure the safety of employees and the quality of products.

The clean room area contains three-stage filtration systems, and air showers are set at the entrance. Separate fresh air, return air, and exhaust systems are used in different clean rooms to minimize the possibility of contamination and/or cross-contamination of manufacturing materials.

Use dedicated manufacturing areas for reactions with higher risk factors such as bromination and chlorination, and regularly investigate potentialsafety hazards in equipment and production systems.

Why Choose BOC Sciences?

Stable market: BOC Sciences has many years of mature API supply system and experience, and has long-term close and in-depth cooperation with many world-class well-known pharmaceutical companies.

Strict manufacturing: Our factories are strictly in accordance with cGMP production management, and have high-pressure hydrogenation, high-temperature and other reaction types, from kilograms to tons of production equipment systems.

Advanced technologies: We have accumulated core technologies in photochemistry, enzyme catalysis, fluid and micro-reaction, and asymmetric catalytic hydrogenation, which are at the international leading level.

Rich variety of raw materials: As a first-class specialty API service provider, BOC Sciences' products cover cardiovascular, central nervous, gastrointestinal and antiviral therapeutic areas.

Emphasis on independent innovation: BOC Sciences attaches great importance to the construction of core team and talent team. More than 95% of our R&D team have a master's degree or above.

Reasonable production layout: Our company has first-class factory buildings and equipment, advanced testing equipment and technologies.

Our high-quality manufacturing services are based on scientific methods, efficient inter-departmental coordination and rich project management experience. Up to now, we have established close cooperative relations with many well-known companies from all over the world. We are constantly expanding our manufacturing scale and technical level, aiming to provide customers with safe and reliable products. If you are interested in our non-GMP & GMP manufacturing service of APIs, please contact us immediately.