Exploring the Benefits of Outsourcing Custom Synthesis Services

May 1, 2024
7 min read

The need for specialized chemicals is ever-increasing in the relentless pursuit of innovation across industries like pharmaceuticals, biotechnology, materials science, and many others. Building and maintaining the infrastructure and expertise for in-house chemical synthesis is costly, time-consuming, and often inefficient for many companies. This is where outsourcing custom synthesis services emerges as a compelling solution, empowering organizations to access the unique molecules they need without the burden of internal development.

What is Custom Synthesis?

Custom synthesis collaborates with specialized chemical manufacturers to produce molecules or compounds not readily available from commercial suppliers. These services encompass a vast spectrum of synthetic needs:

Small-scale synthesis: Tailored production of milligram quantities of novel compounds for initial research, testing, and proof-of-concept studies.

Large-scale synthesis: Production of kilogram-scale batches of active pharmaceutical ingredients (APIs), intermediates, building blocks, and reference standards needed for development, clinical trials, or manufacturing.

Complex and Niche Chemistry: Synthesis of molecules that require specialized expertise, equipment, or techniques, often encompassing areas like high-pressure reactions, chiral synthesis, or handling of highly reactive species.

Key Advantages of Outsourcing

Cost Reduction: Eliminate the substantial capital expenditures and ongoing operational costs of establishing, equipping, and staffing in-house synthesis labs.

Access to Specialized Expertise: Benefit from the knowledge and skills of experienced synthetic chemists, often with expertise far beyond what an individual company could reasonably maintain internally.

Focus on Your Core Strengths: Outsourcing allows your in-house teams to focus their time and resources on your primary research goals and innovation rather than the complexities of chemical production.

Scalability: Seamlessly adjust your synthesis needs as your project demands evolve without the constraints imposed by fixed in-house capacity.

Faster Time-to-Market: Custom synthesis specialists accelerate the product development timeline by leveraging their experience and optimized processes, often significantly faster than building in-house capabilities.

Additional Considerations When Outsourcing

Quality, Not Just Price: Strict quality control and rigorous analytical testing are paramount to ensure the purity and integrity of your synthesized products. Prioritize providers with a proven emphasis on quality.

IP Protection: Robust contracts and confidentiality agreements with your custom synthesis provider are crucial to safeguard your intellectual property throughout the collaboration.

Logistics and Supply Chain: Assess the provider's ability to manage the procurement of specialized materials and ensure a smooth delivery process to your facility.

Why Custom Synthesis is Essential in Drug Discovery

The drug discovery process is arduous and expensive. Custom synthesis plays a critical role for these reasons:

Novel Targets and Therapeutics: Researchers often need unique, never-before-synthesized molecules and intermediates to explore new drug targets and mechanisms addressing unmet medical needs.

Optimized Lead Candidates: Custom synthesis enables the production of structural variations on promising lead compounds, facilitating a rigorous structure-activity relationship (SAR) investigation and improving candidate efficacy.

Supporting the Pipeline: Custom synthesis is necessary to continuously supply APIs, intermediates, and reference standards throughout the development pipeline, from preclinical studies to clinical trials.

ARSI Canada: Your Trusted Custom Synthesis Partner with Deep Expertise

ARSI Canada, based in Mississauga, Ontario, empowers your projects with reliable and high-quality custom synthesis services. Our team of expert chemists possesses a deep understanding of diverse synthetic methodologies, encompassing:

Small and Large Molecule Chemistry: We are adept at handling the complexities of both small and large molecules, ensuring a seamless experience for your project regardless of size or structure.

Complex Chemistry: Our team boasts extensive experience in tackling intricate areas of synthesis, including:

Coupling Reactions: We are proficient in various coupling reactions, such as Suzuki and Buchwaldt, to assemble complex molecules efficiently.

Protein Degradation/PROTACs: We possess the expertise to synthesize PROTACs, a novel class of molecules designed to target and degrade specific proteins.

Specialized Areas: We are experienced in a wide range of technical areas, including hydrogenation, chiral separation, radiopharmaceuticals, nitrosamines, oligonucleotides, amino acids, peptides, carbohydrates, nanomaterials, organometallic chemistry, antibodies & conjugates, LNPs, and stable isotope synthesis.

We are not only equipped to handle these complex areas but are also well-versed in:

Active Pharmaceutical Ingredients (APIs): We specialize in synthesizing various APIs, including pharmaceutical intermediates & excipients, drug analogs, reference standards, degradation products, drug metabolites, analytical standards, and labeled compounds.

Process Scale-Up and Custom Manufacturing: We offer seamless scale-up of your synthesis projects, from milligram quantities for initial testing to kilogram-scale batches for further development or production.

Combinatorial Synthesis: We can generate diverse compound libraries and intermediates to support your research efforts efficiently.

Regulatory Support: Our team is experienced in control strategy development, regulatory starting material strategies, specification setting, determining operating parameter ranges/ORJ studies, and ensuring your projects comply with all necessary regulations.

Method Development and Validation: Our expertise covers complex method development, validation, and technology transfer for organic, inorganic, residual solvents, and trace metals. Additionally, we offer expertise in genotoxin method development and screening, stability-indicating methods, and force degradation studies.

Screening Capabilities: We utilize advanced analytical techniques like HPLC/UPLC, LC-MS/MS, and GC-MS to comprehensively screen organic impurities, nitrosamines, and elemental impurities (Class 1, Class 2A, and Class 2B).

Cleaning Validation: We ensure thorough cleaning validation through rinse and coupon recovery studies, adhering to the strictest quality standards.

Conclusion

Outsourcing custom synthesis offers a strategic advantage for companies across various industries. By partnering with an experienced provider, you can reduce costs, tap into specialized expertise, stay focused on your core innovation, scale your chemical production effortlessly, and ultimately bring your products to market faster.

If you're ready to explore the benefits of outsourcing custom synthesis, contact ARSI Canada today. Let us help you synthesize the molecules that drive your research and development forward. Request a quote or schedule a consultation to discuss your specific project needs.

Kazi Habib
A seasoned professional with over 15 years of experience in the pharmaceutical field, brings a wealth of knowledge to the world of science

His journey spans across pharmaceuticals, Contract Development and Manufacturing Organizations (CDMOs), and biotechnology companies.

Beyond the corporate landscape, Kazi’s true passion lies in translating complex scientific concepts into accessible and engaging content. With a keen eye for detail and unwavering commitment to excellence, he crafts thought-provoking articles that bridge the gap between science and curious minds.

Join Kazi on an enriching journey through the captivating world of chemistry. Here, insightful analysis meets a fervor for sharing knowledge, creating a space where scientific exploration and engaging storytelling converge.