Custom Development Services
Streamline Your Program’s Development
Explore Wheeler Bio’s comprehensive suite of development capabilities, ranging from pre-clinical cell line expression, process and analytical development to late stage process characterization. Our development approaches empower our clients to accelerate the discovery and development of innovative biotherapeutics as part of our Portable CMC® platform or as standalone services. Our team of highly skilled scientists and engineers harness the latest technologies and methodologies to support your project’s success.
Learn more about what Wheeler Bio’s team can bring to your program.
Wheeler Bio provides high-quality transient protein expression services for drug developers, enabling them to swiftly produce and characterize their product candidates, thereby accelerating time to final candidate selection. Our dedicated protein sciences team – based in Waltham, MA and Oklahoma City – utilizes vast experience in protein design and expression to design experiments that will meet your needs in generating and characterizing multiple constructs for final candidate selection.
Leveraging our team’s extensive expertise and proprietary technologies, we ensure efficient and optimal results through CHO- and HEK-based transient protein expression and the utilization of cutting-edge systems like Expi293 and Leap-In Transposase technology for the rapid generation of milligram to gram quantities of stable recombinant proteins. This material is then used for rapid and cost-effective molecular format screening and vector engineering to enhance the final candidate, making Wheeler’s platform particularly advantageous for early-stage drug developers looking to maximize their resources while on a tight timeline to proof-of-concept studies.
Wheeler Bio is your partner of choice for high-quality, scalable CHO cell line development as a standalone service utilizing any of the major industry-proven CHO systems, or as part of our Portable CMC® platform,utilizing the ATUM Leap-In Transposase ® expression system. Leveraging our cutting-edge Oklahoma City Integrated Process Development Lab and highly experienced technical team, our CLD workflows have been precisely redefined to maximize productivity and cell line robustness, while also reducing costs and expediting Chemistry, Manufacturing, and Controls (CMC) developmental timelines.
Our teams offer tailored solutions for each drug candidate utilizing industry-proven cell line development technology like the Solentim® Ecosystem for single-cell isolation and imaging, Ambr® systems for high throughput clone screening, and in-house scale-up and purification capabilities. Our mammalian-based cell line development services deliver reliably high yields and robustness, leading to no process limitations while on an accelerated path to CMC development.
Wheeler Bio boasts a world-class process development and optimization team that specializes in CMC process development, refinement, and transfer strategies. With extensive experience and a stellar track record of creating robust manufacturing processes efficiently, we offer comprehensive solutions for CMC development and drug substance delivery needs. Wheeler Bio’s approach includes de-risking early-phase development by starting with multiple therapeutic antibody candidates, and narrowing down to the lead candidate as process development culminates.
Utilizing advanced design of experiments and high-throughput lab equipment, we rapidly develop processes to our platforms that are proven, scalable and robust. Our process and analytical development strategy is tailored for clients seeking to optimize and de-risk their antibody therapeutic programs with reliable and scalable processes for toxicology and clinical drug substance supply.
Wheeler Bio recognizes the critical role of analytical development and qualification in ensuring the safety, quality, and efficacy of biopharmaceutical products that will enable your regulatory approvals. Within our cutting-edge Oklahoma City Integrated Process Development Lab, we offer an extensive array of analytical services designed to expedite your drug development endeavors. Our comprehensive suite of capabilities ensures that all analytical methods are meticulously characterized, paving the way for subsequent development and manufacturing operations and maintaining your program’s compliance with regulatory standards.
Leveraging our profound expertise and advanced instrumentation, we offer services ranging from method development and optimization to stability testing, all aimed at enhancing sensitivity, accuracy, and efficiency in your analytical testing. Moreover, we excel in qualification processes, assuring the reliability and traceability of analytical results in line with regulatory guidelines.
Wheeler Bio is a leading provider of formulation development services, boasting a team of seasoned experts with extensive experience in biopharmaceutical drug formulation. Located at the state-of-the-art Oklahoma City Integrated Process Development Lab, we employ cutting-edge equipment and technology to create safe, reliable, and stable bulk liquid formulations. These formulations serve as the foundation for drug products as they progress from discovery through clinical trials and beyond.
Wheeler Bio stands out for its expedited formulation development and screening process, featuring machine-learning models and Design of Experiments (DoE) techniques. This approach allows for the rapid identification of optimal drug product formulations and ensures compliance with ICH stability guidelines, preventing potential bottlenecks in the drug development process.
Our toxicology material supply services are designed to rapidly provide you with reliable and high-quality materials for preclinical and clinical development. Wheeler leverages our CLD and process platforms to rapidly provide toxicology material supply using either our Portable CMC® offerings, or through rapid transfer of client cell lines onto our process platform. Wheeler Bio’s innovative suite of services allow for a unique approach that optimizes the path to toxicology material supply and streamline your drug development process through efficient study design, reliable material generation, and data-driven decision making.
Whether leveraging our Portable CMC® CLD and process platforms, or utilizing client supplied cell lines and processes, Wheeler’s transformative approach can speed your toxicology material supply in a reliable manner.
In Wheeler’s commitment to bridge the translational gap between discovery and early clinical CMC manufacturing, we take the transfer from the development labs to manufacturing very seriously. The technology transfer process is a critical step to ensure manufacturing success, whether it is Wheeler performing phase 1 CGMP drug substance manufacture, or whether we are supporting your process transfer to your manufacturing partner of choice.
Wheeler’s team of industry experts are highly experienced in tech transfers and offer a unique transfer package designed with all relevant stakeholders in mind. Following the culmination of process development, our cross-functional tech transfer teams use a risk-based perspective to ensure a seamless transition to manufacturing. Our team excels in facilitating the transfer of knowledge, conducting rigorous risk assessments, and navigating the intricacies of regulatory compliance to expedite your product’s journey to market while mitigating risks and ensuring the highest standards of quality and compliance.
Wheeler Bio is well versed in supporting the translational space from discovery to early clinical trials, while also having a deep understanding of late-stage process characterization to support process validation and commercialization. Wheeler’s robust process characterization strategy lays the foundation for commercial process validation and BLA approval by the FDA, in an efficient and timely manner.
Our highly qualified experts will design and execute PC studies that scrutinize every facet of your processes, from inception to final output. This meticulous examination not only ensures compliance with stringent regulatory standards, but also empowers your program with invaluable insights for further robustness and optimization. Our unwavering commitment to process characterization will provide robustness in productivity and product quality attributes, while also enabling enhanced operational efficiency to provide you a competitive edge, in a competitive industry.