Manufacturing Services
Antibody-drug conjugates (ADCs) act by directly targeting and then killing selected cells, affecting both the growth and behavior of cells. ADCs are typically used to treat unwanted malignancies and tumors but are also being developed for use in a number of other therapeutic areas. They represent one of the fastest growing segments of the pharmaceutical and biotechnology industry.
While antibody-drug conjugates have widespread treatment potential, the successful and safe manufacturing of these highly potent drugs requires a highly skilled team of experts and well-controlled manufacturing facilities. ADCs consist of three parts: an antibody specific to the target associated antigen, a payload designed to kill target cancer cells, and a chemical linker to attach the payload to the antibody.
antibodies, payloads, bioconjugation and sterile fill/finish. This integrated capability for the development and manufacture of ADC products can accelerate program timelines and reduce program complexity, resource requirements and risk.
We offer integrated development and manufacturing services across the ADC components: antibodies, payloads, bioconjugation and sterile fill / finish.
About
Solid Form Services
The selection of a lead solid form of an API is a critical step in early pharmaceutical development. Determining the most suitable chemical and physical form impacts a range of critical parameters including manufacturability, stability and bioavailability. The selection of a lead solid involves the screening and characterization of chemical forms (free form, salts, hydrates, solvates and cocrystals) and polymorphs and/or amophous forms Every molecule is different with varying propensity for polymorphism and the formation of hydrates and solvates. Additionally, the physicochemical properties of the molecule and the target product profile will determine the need for screening salts, cocrystals or bioavailability-enhanced formulations. These properties will also determine solubility, dissolution rate and/or manufacturability of any solid form.
The selection of a lead solid form of an API is a critical step in early pharmaceutical development. Determining the most suitable chemical and physical form impacts a range of critical parameters including manufacturability, stability and bioavailability. The selection of a lead solid involves the screening and characterization of chemical forms (free form, salts, hydrates, solvates and cocrystals) and polymorphs and/or amophous forms Every molecule is different with varying propensity for polymorphism and the formation of hydrates and solvates. Additionally, the physicochemical properties of the molecule and the target product profile will determine the need for screening salts, cocrystals or bioavailability-enhanced formulations. These properties will also determine solubility, dissolution rate and/or manufacturability of any solid form.
Tailored services to fit your specific ADC payload program
Early handling protocols for your compound Analytical methods to support your early formulation prototype characterization including assay, purity and dissolution Phase-appropriate methods to support batch release and stability testing of early phase compound, intermediate or drug product manufacturing Method optimization to ensure robustness Finalization of analytical methods to support your Phase III, registration and commercial drug substance or drug product manufacturing to cGMP guidelines Finalization of analytical methods to support your Phase III, registration and commercial drug substance or drug product manufacturing to cGMP guidelines
- cGMP laboratory suites Advanced ADC synthesis across a range of chemical technologies Validated cleaning procedures and OEL levels of 100ng- 1ng Dedicated facilities and staff for processing in isolators, big bag handling, clean room manufacturing Development and manufacture for gram-scale and multi-kilogram scale Regulatory support services
Experts in Antibody-Drug Conjugate Components
Our customers can leverage our unique infrastructure for ADC payloads and overall ADC capabilities to avoid extra investment in expertise, assets and infrastructure required to work with these very highly potent applications. Flexible business models can be discussed and agreed upon to ensure supply secure arrangements that meet individual needs for antibody drug conjugate customers and programs.
FAQ
Know our Manufacturing Services
Defined work with customization
Lysis Pharma solid form services are built on a foundation of API characterization, materials science and problem statement analyses core to our API development and bioavailability-enhancement service portfolios. In-house equipment and expertise is in place to rapidly understand the solid form landscape of your molecule.
Particle engineering at Lysis Pharma
We provide customized and fit-for-purpose particle engineering services as part of our integrated drug substance and drug product development services. Phase-appropriate particle size reduction processing, spray dryers, hot melt extrusion, and melt-spray-congealing is in place to advance your compound from concept to clinical and commercialization. Particle size reduction to precise particle size distribution is in place for API milling across pin mill, hammer mill, jet mill and nano-mill processing. Particle engineering services using spray drying, hot-melt extrusion, or melt-spray-congealing are also provided.
Particle Size Reduction
Particle size reduction via micronization or nano-milling and amorphous solid dispersion technology via hot-melt extrusion or spray drying are often utilized to improve stability, flowability, dissolution rate and solubility. The choice of technology is dependent upon the API characteristics, target product profile and application. We have advanced thousands of molecules across a myriad of API parameters, applications and target product profiles. This experience has been used to develop technology selection methodologies incorporating models and reference maps over key formulation parameters.
Our particle size reduction experience has also been utilized by our engineers to develop proprietary lab-scale processing that requires minimal amounts of API for feasibility assessments. Our product development teams utilize these tools to rapidly select and employ the best particle engineering approach to address the problem statement(s) and meet the target product profile in a phase-appropriate manner.
Particle Size Optimization Expertise
Our product development teams are well versed in particle size reduction to low micron or sub-micron levels, as well as amorphous solid dispersion technologies. Specialized jet mill and spray dryer designs have resulted from decades of engineering study and provide optimized particle size distribution and performance.
We offer fully integrated product development from active pharmaceutical ingredients through particle-engineered intermediates to finished drug products. Our particle engineering service packages include feasibility trials, robustness studies, design of experiment (DOE) in non-GMP and GMP environments, process development and optimization, analytical services, QC / QA, CMC and regulatory services.
Dedicated product development teams are in place for dry powder inhaler applications using either jet milling or spray dry processing. Encapsulation for clinical trial materials and commercialization are in place to service your particle engineering or particle size distribution requirements from concept to commercial.
We have decades of particle engineering experience across thousands of compounds spanning the full range of formulation challenges.
Particle engineering capabilities at lab and pilot scale are also available for particle size reduction and spray dry processing of drug substances as required to meet desired API characteristics and target drug product profiles.
Specialized Particle Engineering Focus
We have invested in specialized particle engineering processing to ensure that the needs of any compound can be addressed. High containment capabilities are in place so that mechanical, jet milling and spray drying can be safely conducted with highly potent API or cytotoxics. Before processing, every drug substance is evaluated by our team to determine the containment system required.
Specialized cryogenic API milling is also in place for those friable compounds needing cooling due to low melting points or to avoid polymorphism.
Specialized HPAPI R&D labs and small scale plants support early phase clinical to low volume commercial production of potent compounds (to OEL ≥ 1ng/m3) and ADC payloads.
Bioavailability Enhancement Services
The depth of our bioavailability (BA) enhancement offering makes us a leader in addressing low solubility, low bioavailability and dissolution rate issues. We work collaboratively with our customers to advance compounds, or re-purpose existing compounds, across a full range of API properties and delivery challenges. Our end-to-end solutions incorporate full capabilities in bringing a compound from concept to commercialization, thereby minimizing program complexity, timelines and risk.
Industry estimates indicate that more than 80% of new chemical entities exhibit low solubility, low bioavailability and / or low or inconsistent dissolution rate. Effectively addressing these drug solubility, bioavailability and dissolution rate problems is essential for advancing the compound and providing the desired therapeutic benefit of the drug product to patient. And ensuring that the solubility solution incorporates the ultimate manufacturability of the drug product can avoid time-consuming re-formulation and rapid advancement to market.
We recognize the core challenges of advancing the new chemical compounds in today’s biopharmaceutical pipeline. That’s why we have developed a portfolio of bioavailability enhancement technologies and services with which to address poor solubility and inadequate or inconsistent dissolution rate.
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Email Us
info@lysispharma.net
Office
Chisholm Trail
Road,
Suite:450
Round
Rock, TX 786810
Monday – Friday
8.00am – 8.00pm
Saturday
10.00am – 4.00pm
Sunday
10.00am – 4.00pm