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Comprehensive CDMO Services
Lambda Therapeutic Research Ltd. is positioning the “Contract Development & Manufacturing Organization (CDMO)” in its vision to serve as an integrated solutions provider for biologics drug development, GMP manufacturing, and to enable First in Human (FIH) clinical trials globally.
Our flexible capacity and equipment trains, combined with our agile, collaborative approach, give us the ability to scale up any biologic product for each unit operation – from pilot batch to clinical quantities – to accelerate the time to file and market.
In this integrated offering, the following cutting-edge technical functions will be fully engaged in providing end-to-end support to our customers in bolstering the development pathway for their lead biologics/bio-therapeutics or biosimilars.
Facility and Infrastructure:
Lambda CDMO’s state-of-the-art facility is built on around 20,000 sqft area with development and manufacturing functions. This will enable cGMP manufacturing services that will provide our prospective customers the opportunity to manufacture kilogram quantities of biologics drug substance (DS) and drug product (DP) of the highest quality to support their clinical development pathways. The manufacturing facility is well-equipped and qualified with current quality requirements, including appropriate area grades, controlled movements, and separated sterile operations. Lambda aims to become a co-development partner and support reliable long-term supply requirements by building sufficient manufacturing capacity.
Services
Each of the functional areas that contribute to the development and manufacturing of biologics will also focus on capability enhancements to support any client requirements:
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Cell line engineering for monoclonal antibodies (mAbs), bi-specifics, and bi-functionals.
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Cell culture and downstream processing for DS manufacture.
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Formulation development for drug product manufacturing.
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Continuous manufacturing and process intensification for mAbs.
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Physico-chemical analysis for batch release, stability, and characterization.
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Characterization of higher-order structure.
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Orthogonal analytical tool kits, which can support characterization of additional isotypes (IgG2 and IgG4, apart from IgG1) of mAbs and other related scaffolds, including antibody-drug conjugates.
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In vitro bioassays for mAbs, ADCs, bi-specifics, and bi-functionals.
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Microbiological assays (e.g., sterility test, Microbial Limit test, and BET test).
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In vitro immunogenicity assays to define safety risks for novel biologics and peptides.
Expertise
The management and scientific team in our CDMO are highly talented with wide international experience in process and analytical sciences for the development, manufacturing, and technology transfer of biologics. The team is focused on clients’ requirements and is sensitive to the cruciality of on-time and in-full deliverables, which expedite clients’ programs to reach the market on time. The leadership team is well-versed in:
- Flexibility and speed with a focus on product quality.
- Phase-specific development with a singular focus on accelerated early-phase development.
- Continuous improvement to provide cost-effective solutions.
- Strong IP protection and robust data integrity.
- Proactive and transparent communication through well-defined project management.
- Problem-solving and risk assessments.
The Lambda advantage is built on the three pillars that focus on customer engagement – accelerate, simplify, and succeed. These pillars enhance value for our customers and support their development requirements.
Accelerate
Advance your projects from concept to market with our streamlined processes.
Simplify
Simplifying complex workflows to enhance efficiency and reduce operational burdens
Succeed
Achieve your development goals with our tailored solutions and expert support.
Quality and Regulatory Compliance:
The cGMP manufacturing facility is being built with current global requirements for regulations and compliance in mind. We can seamlessly support client requirements for dossier filings in highly regulated markets (US, EU, Japan, TGA, etc.). We are building rigorous quality systems for data integrity, data retention, customer transparency, information, and intellectual property security by ensuring robust firewalls and compliance systems. Our quality system will enable clients to count on us for integral, uniform, and continuous deliveries of products and services.
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