Services

Affinity's Full-Time Equivalent (FTE) Services provide pharmaceutical and biotech companies with a comprehensive chemistry solution, offering flexibility and consistent control over their outsourced research programs.

Advantages of our FTE services include:

• Flexible terms tailored to your specific needs, including team size, duration and scope.
• Proven track record in rapidly delivering multiple leads and clinical candidates for our clients.
• A highly qualified team of chemists known for their critical thinking, problem-solving abilities, and high level of productivity.
• Stringent intellectual property (IP) protection measures to safeguard our clients' interests, along with high-quality notebook and record keeping.
• Dedicated project management, technical leadership, and resource allocation to ensure efficient project execution and delivery.

Interested in learning more about our FTE services? Click here to submit an inquiry.

One of our core strengths lies in our ability to deliver hard-to-find molecules and materials through custom synthesis services. We are committed to accommodating projects of any size, with no project considered too small for our attention. 

Custom synthesis serves as a cornerstone for establishing long-term relationships and collaborations with our valued customers. 

Your satisfaction is guaranteed, as we consider repeat business to be our most effective marketing strategy.

We provide custom synthesis services for a wide range of compounds (from milligrams to kilos), including:

• Reference standards, metabolites, and impurities
• Lead-like or drug-like compounds
• Diversity-oriented building blocks
• Unnatural amino acids, peptides, nucleosides, and nucleotides
• PEG linkers, ADC linkers, PROTAC linkers, and fluorescent dyes
• Biodegradable polymers
• And more...

Let us know your specific needs, and we'll tailor our synthesis to meet your requirements. Click here to submit an inquiry.

From initial evaluation to full-scale production, we provide comprehensive support at every stage of chemistry process development, continually enhancing your operational efficiency. Our expert team excels in developing processes that overcome common hurdles such as budget constraints, safety concerns, scalability issues, and sustainability.

Our process chemistry services encompass a wide array of activities, including, but not limited to:

• Evaluation of existing routes 
• Safety and scalability analysis
• Design and exploration of new synthetic routes
• Optimization of reaction conditions 
• Development of isolation and purification methods
• Development of analytical methods
• Salt screening and recrystallization
• Pilot-run validation of processes
• Pilot-scale production to support early-stage development
• Technology transfer to manufacturing sites

Click here to submit an inquiry and share your process needs with us. Our expert team is ready to assist you.

Engaging in chemical manufacturing involves several critical components, such as recruiting and training skilled personnel, acquiring and maintaining expensive equipment, and ensuring compliance with regulations, which can be daunting, especially for startups and small companies aiming to bring products to market swiftly. Whether at pilot-scale production or full-scale manufacturing, we are fully prepared to offer comprehensive assistance throughout the process.

Whether you possess a laboratory-scale chemical process or lack one entirely, our dedicated process team will take charge of the project from its inception. Working closely with our engineering team, they will devise a viable route and efficiently scale it up for manufacturing.

What sets us apart as your ideal manufacturing partner?

1. Environmental, health, and safety (EHS) are our top priorities. We prioritize long-term sustainable growth and adhere strictly to ethical practices.
2. We continually invest in cutting-edge technologies, including green processes, continuous flow processes, and automation, to enhance efficiency and sustainability.
3. We handle all aspects of the manufacturing process, from raw material procurement and inventory warehousing to process development, production, regulatory compliance, and logistics.
4. We hold all necessary certifications and registrations, and maintain a comprehensive quality assurance (QA) system to ensure consistently high standards.

Most active pharmaceutical ingredients (APIs) encompass diverse solid forms with distinct properties, including solubility, dissolution rate, stability, hygroscopicity, and bioavailability. Consequently, meticulous screening, characterization, and selection of solid forms are imperative for ensuring the quality of APIs. Our adept solid-state chemistry team collaborates seamlessly with our synthesis team to navigate the complete process development lifecycle.

Our solid-state studies encompass a range of activities, including:

• Polymorph/salt screening and selection
• Crystal/co-crystal form identification and characterization
• Amorphous (non-crystalline) material development and solid dispersion development
• Single crystal growth and absolute structure determination
• Thermodynamic phase relationship study
• Stability and hygroscopicity assessment
• Solubility and dissolution performance evaluation
• Solid-State NMR analysis