Litchla, a global leader in liposome-based drug delivery technologies, is excited to announce the expansion of its Active Pharmaceutical Ingredient (API) services. With its state-of-the-art facilities and more than a decade of expertise, Litchlab is now offering a comprehensive suite of services that cater to a range of drug development needs—from preclinical research to large-scale commercial production. The company also brings specialized solutions to support the development of Antibody-Drug Conjugates (ADCs) and Radionuclide Drug Conjugates (RDCs).
Transforming API Development and Manufacturing
As the demand for complex and precision therapies grows, Litchlab’s advanced API capabilities are designed to meet the evolving needs of biopharma companies. By combining cutting-edge technology with deep expertise in chemistry and drug formulation, Litchlab supports a wide range of drug modalities including small molecules, biologics, ADCs, and other targeted therapies.
“We are committed to empowering our clients with flexible, scalable, and high-quality API solutions,” said, CEO of Litchlab. “Our expanded API capabilities, particularly in the development of ADCs and RDCs, ensure that we can support the next generation of precision therapies, bringing life-saving innovations to market faster.”
Key Highlights of Litchlab’s API Services
1. Custom API Development and Optimization
Litchlab specializes in the development of tailored APIs with a strong focus on process development, route scouting, and solid-state chemistry. Their expert team employs advanced analytical tools and in-depth chemical knowledge to identify efficient synthetic pathways, reduce impurities, and enhance the bioavailability and stability of active ingredients.
2. Non-GMP API Supply for Preclinical Studies
Litchlab offers flexible, small-scale API production for preclinical studies, providing quantities ranging from milligrams to kilograms. This service is ideal for early-stage research, enabling clients to quickly move from discovery to initial trials while maintaining flexibility in timelines and production scale.
3. GMP-Compliant Clinical API Manufacturing
Litchlab’s GMP-certified facilities provide scalable, multi-step synthesis of APIs, including drug substance production for clinical trials. The company’s expertise spans across complex chemistries such as high-potency API (HPAPI) synthesis, chiral separations, and purification, ensuring that the final product meets rigorous global regulatory standards for clinical and commercial applications.
4. Advanced Conjugation Services for ADCs and RDCs
As ADCs and RDCs gain traction in oncology and targeted therapies, Litchlab offers specialized services in payload development and conjugation chemistry. Their platform focuses on high-potency, stable, and effective payloads that are conjugated to antibodies or other targeting agents with precise control over drug-to-antibody ratios (DAR), enhancing therapeutic efficacy while minimizing off-target toxicity. Litchlab also provides customized solutions for the development of radionuclide conjugates for targeted radiotherapy.
5. Process Scale-Up and Manufacturing Support
Litchlab’s API services are equipped to scale from laboratory and pilot-scale production to large-scale GMP manufacturing, ensuring a smooth transition through the entire development pipeline. This includes optimization of production yields, purification techniques, and process safety evaluations to ensure that APIs meet the required standards for both clinical trials and final commercial production.
6. Regulatory Expertise and Compliance
With a strong track record in regulatory submissions, Litchlab assists clients with meeting global regulatory requirements for API production. From preclinical through to commercialization, Litchlab provides regulatory guidance to ensure API and formulation compliance with FDA, EMA, and other global regulatory agencies.
State-of-the-Art Facilities and Expertise
Litchlab’s cutting-edge GMP facilities are designed to support advanced manufacturing and multi-step synthesis of APIs. Their capabilities include PEGylation, polymer and copolymer manufacturing, and continuous flow chemistry for high-efficiency production. Additionally, their expertise in working with high-potency APIs and complex conjugates such as ADCs and RDCs ensures they can offer integrated solutions to biopharma companies seeking to develop next-generation therapies for challenging diseases.
A Partner for the Future of Drug Development
By expanding its API services, Litchlab continues to meet the growing demand for precision, targeted drug delivery solutions. With a focus on efficiency, scalability, and regulatory compliance, Litchlab is positioned as a trusted partner for biopharma companies looking to bring complex therapies to market, from preclinical studies through to commercial production.
To learn more about Litchlab’s innovative liposome technology and its latest developments,please feel free to contact us at:
E-Mail:RD1@Litchlab.com
