Active Pharmaceutical Ingredients (APIs) constitute the pharmacological foundation of modern medicine, requiring precise chemical synthesis, rigorous purification, and scalable processing. The complexity of modern drug candidates demands manufacturing partners who can navigate intricate synthetic pathways while maintaining strict control over impurities and physical properties. BOC Sciences offers comprehensive API manufacturing services, bridging the gap between laboratory discovery and commercial reality. From route scouting and process optimization to pilot scaling and full-scale production, we utilize advanced chemical engineering technologies to deliver high-purity APIs. Our integrated approach supports the pharmaceutical and biotech industries in securing a robust supply chain, optimizing cost-efficiency, and ensuring the technical excellence of their therapeutic compounds.
Chemistry Optimization & Feasibility
Scale Transition & Validation
High-Volume Supply & Efficiency
BOC Sciences delivers technical excellence in chemical synthesis and manufacturing, ensuring timely delivery and strict adherence to your quality specifications.
BOC Sciences supports a wide array of chemical entities, adapting our manufacturing protocols to the specific stability and reactivity profiles of your target molecule.
Provide your project details or target molecule, and our process chemists will assess feasibility and design a scalable manufacturing strategy.
Evaluate submitted requirements and target molecules, assess synthetic feasibility, and develop preliminary routes and production plans.
Conduct lab and pilot-scale development and optimization, validate route scalability, and control impurities while ensuring product stability.
Carry out pilot or commercial-scale production with strict quality testing to ensure batch purity and consistency.
Deliver APIs according to specifications and provide comprehensive technical documentation, analytical reports, and ongoing support.
Many APIs feature complex structures or high potency, making scale-up from lab to commercial production challenging. BOC Sciences utilizes advanced synthesis platforms and containment systems to enable safe handling of highly active molecules. Our customized processes ensure reaction stability and successful scale-up for sensitive compounds.
Complex synthetic routes often generate multiple impurities, making batch-to-batch consistency difficult across scales. We utilize state-of-the-art separation and analytical technologies, including chromatography and mass spectrometry, to monitor impurity formation. This rigorous monitoring ensures every API batch meets strict purity and quality standards.
Scaling laboratory processes to commercial production can result in reduced yields or raw material shortages. BOC Sciences applies scientifically designed scale-up strategies and maintains a reliable supply network to minimize risks. Our approach ensures production efficiency and flexibility to adapt manufacturing to client demands.
Accelerated timelines require thorough verification and seamless communication to prevent project delays. Our expert process chemistry team is fully engaged from initial evaluation through batch production. Detailed technical documentation and continuous communication ensure client requirements are accurately and efficiently realized.
Our co-located R&D and manufacturing sites allow for rapid troubleshooting and seamless scaling. Chemists who developed the process are directly involved in the technology transfer and plant start-up.
We offer a versatile range of reactor sizes (from 50L to 5000L) and materials (glass-lined, stainless steel, Hastelloy), enabling us to handle diverse chemical reactions and batch sizes tailored to your demand.
Our manufacturing operations are governed by a comprehensive quality management system. We maintain complete data integrity, material traceability, and rigorous equipment cleaning protocols to ensure product purity.
We excel at "difficult-to-make" molecules. Our team thrives on overcoming synthetic challenges, whether it involves unstable intermediates, complex purification, or hazardous reaction conditions.
Client Needs: A biotech client needed to scale up a reaction involving a highly exothermic nitration step that was deemed unsafe for traditional batch reactors at the kilogram scale.
Challenges: The exothermicity posed a runaway risk in large vessels, and the impurity profile degraded rapidly if temperature control was not precise. Standard jacketed reactors could not provide the necessary heat removal rate.
Solution: BOC Sciences' engineering team developed a sophisticated continuous flow process utilizing high-efficiency micro-reactors. This specialized setup provided an exceptionally high surface-area-to-volume ratio, enabling superior heat exchange and precise residence time control to suppress side reactions. We conducted rigorous validation of the flow parameters at the laboratory scale, including pressure-drop analysis and mixing efficiency tests, before seamlessly transferring the optimized protocol to a modular pilot-scale flow skid.
Outcome: The reaction was successfully scaled to produce 50kg of intermediate with a 15% increase in yield compared to the batch process and a significantly improved safety profile, enabling the client to proceed to the next development stage.
Client Needs: A pharmaceutical partner required a cost-effective route for a chiral amine API. The original route relied on an expensive chiral resolving agent and had a low overall yield (less than 20%).
Challenges: The existing resolution process generated large amounts of waste and required multiple recrystallizations to achieve the target optical purity (>99.5% ee). The cost of goods was too high for commercial viability.
Solution: Our process chemists conducted a high-throughput screening of an extensive enzyme library, successfully identifying a highly selective transaminase capable of direct asymmetric synthesis. To enhance the commercial viability, we optimized the reaction environment and engineered an innovative, integrated cofactor regeneration system that minimized auxiliary reagent consumption. This bio-catalytic approach replaced the traditional resolution method, streamlining the synthesis into a more sustainable and atom-economical "green chemistry" framework.
Outcome: The new bio-catalytic route increased the overall yield to 85% and eliminated the need for heavy metal catalysts. The optical purity consistently exceeded 99.8%, and the manufacturing cost was reduced by 40%.
Client Needs: A generic drug manufacturer faced a supply chain disruption and needed a secondary supplier to rapidly produce 500kg of a key intermediate within 3 months.
Challenges: The timeline was extremely aggressive. The tech package from the client was incomplete, lacking critical data on filtration times and drying curves, which risked production bottlenecks.
Solution: BOC Sciences mobilized a multi-disciplinary 24/7 task force to expedite every stage of the project. We performed rapid process familiarization and "stress-testing" in the Kilo Lab to generate the essential engineering data, specifically focusing on crystallization kinetics and solid-liquid separation parameters. Concurrently, our global sourcing team utilized our verified vendor network to secure high-quality raw materials, while the quality team established parallel analytical method validation to ensure no delays in batch release.
Outcome: We successfully completed the campaign one week ahead of schedule. The material met all purity specifications, preventing a stock-out situation for the client's final drug product.
BOC Sciences possesses extensive experience in process scale-up, ensuring a smooth transition from lab-scale synthesis to pilot and commercial production. Our engineering team conducts in-depth studies on reaction thermodynamics and kinetics, optimizing stirring efficiency, heat transfer, and dosing strategies to mitigate byproduct increases or yield fluctuations. This comprehensive technical assurance ensures that target molecules maintain high consistency and process stability across various manufacturing scales for reliable supply.
We hold significant technical advantages in handling challenging reactions, including multi-step synthesis, chiral resolution, and asymmetric catalysis. BOC Sciences’ chemists excel at designing efficient synthetic routes, utilizing advanced catalytic systems and protective group strategies to precisely construct complex molecular frameworks. Whether introducing specific functional groups or controlling stereochemistry, we provide customized solutions to overcome technical bottlenecks in the large-scale manufacturing of high-value API products.
Through systematic process risk assessments, we strictly monitor starting materials, intermediates, and potential byproducts during manufacturing. BOC Sciences utilizes high-sensitivity analytical techniques to perform deep impurity profiling and suppresses impurity formation by optimizing crystallization or purification processes based on a profound understanding of reaction mechanisms. This source-control approach enhances overall quality stability and provides clear, transparent physical property parameters for subsequent pharmaceutical research.
BOC Sciences is equipped with specialized processing equipment capable of executing high-pressure hydrogenation, cryogenic reactions, and highly exothermic hazardous chemical processes. Our facilities integrate automation systems to precisely regulate reaction parameters, prioritizing energy efficiency and operational safety. This diverse technical repertoire allows us to undertake extreme chemical transformations, achieving efficient batch or continuous production of APIs with unique structures while maintaining rigorous operational stability.
During API manufacturing, we emphasize solid-state characterization, including polymorphism, particle size distribution, and hygroscopicity. BOC Sciences offers systematic crystallization process development to screen for the most stable crystal forms or specific amorphous states based on project needs. By precisely controlling nucleation and growth conditions, we ensure products possess excellent powder flowability and processing performance, enhancing the feasibility of downstream formulation development and ensuring consistent physicochemical properties.
BOC Sciences solved a synthetic bottleneck that had stalled our project for months. Their process development team suggested a novel catalyst that improved our yield significantly. Their ability to translate chemistry from the board to the plant is outstanding.
— Dr. Anderson, VP of CMC, Emerging Biotech
We rely on BOC Sciences for the production of our key intermediates. They have consistently met our delivery timelines and quality specifications. Their transparency regarding raw material sourcing gives us great confidence in our supply chain security.
— Mr. Thompson, Sourcing Director, Global Pharma
Moving our process to BOC Sciences was a smooth experience. Their engineers asked the right questions during the evaluation phase, and the pilot run matched our lab results perfectly. A truly professional manufacturing partner.
— Ms. Lewis, Manufacturing Manager, Specialty Chemical Co.
The purity profiles of the APIs delivered by BOC Sciences are exceptional. Their documentation is thorough, and their quality team is very responsive to our audit requests and questionnaires.
— Dr. Hamilton, QA Director, Generic Drug Manufacturer
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