Portable CMC®
Portable CMC® Services
Portable CMC® Services
Wheeler Bio’s Portable CMC® services empower clients to navigate the complex biologics landscape with ease, delivering high-quality and scalable biopharmaceutical solutions for the benefit of patients worldwide. With Portable CMC®, our team can deliver a seamless transition from early-stage development to manufacturing, ensuring efficiency, flexibility, and accelerated timelines.
This innovative approach enables clients to rapidly advance their biologic candidates
from lead identification coming out of discovery to drug substance and drug product
supply for clinical trials. The workflows integrate cell line development, process development, analytical development, and manufacturing services.
A New Tier of Customer Experience
Wheeler’s Portable CMC® platform is underpinned by our steadfast commitment to advancing innovation through collaboration, data transparency, and platform accessibility. When integrated with antibody discovery processes, innovators benefit from:
Funding Alignment
Modular work packages aligned to your product’s development and fundraising milestones
Accessible Platform
Reduced risk with a predictable scope and no large upfront financial commitments
Affordable Workflow
All-inclusive pricing with the option to defer cloning until programs are clinic-ready
Process Freedom
Open-source, client-owned processes for de-risking scale-up and tech transfers
Speed to Clinic
Pool-based workflows for rapidly progressing through CMC milestones
From Discovery to IND
Drug innovators today are faced with difficulties in finding CDMO providers that are focused on bridging the gap between drug discovery and first-in-human clinical studies. Portable CMC® is a thoughtfully designed package of innovative services that integrates the translation from lab discovery into efficient and scalable clinical CGMP manufacturing.
Using innovative tools, advanced process and analytical methods for development and drug substance manufacturing along with data-science based tech-stacks, Portable CMC® provides an efficient bundling of work packages, coupled with a high quality data package, to deliver three core CMC development offerings — Lead to Manufacturability, Lead to Tox, and Lead to Clinic — to provide our clients with a new tier of accessibility.
An Accelerated Path to the Clinic
Based on our most commonly selected work packages, our core offerings are designed to meet your CMC milestones with flexibility:
From sequence to lead molecule selection using CHO pool cultures
Pool-Based Early Product Assessment
Lead to Manufacturability provides a rapid, easy-to-access option for generating highly representative materials, early product quality attribute assessments, manufacturability data, and materials for additional developability considerations to reduce the risk of lead molecule selection in the drug discovery process. Wheeler leverages the industry leading and FDA- accepted Leap-In Transposase mediated gene delivery system from ATUM to enable a cost-effective, easily implemented cell line CHO pool generation workflow, delivering high productivity non-clonal cell lines with pool-to-clone consistent product quality. Work packages 1 and 2 are used to scale CHO pools to stable bulk cultures for four, or more, product candidates that are then tested in shake flask and bench-top bioreactor fed-batch cultures for subsequent product quality testing, formulation screening and product supply using Wheeler’s well-characterized process platform.
Work Packages
1.Bulk Stable Pool Product Quality Assessment
2.Manufacturability Assessment in Stable Bulk Pools
Lead to Manufacturability comprises the following deliverables:
- CHO pool expression of 4, or more, antibody candidates
- Product quality attribute assessment for multiple mAb candidates
- Up to 50 mg of Protein A purified material for multiple lead mAb candidates
- Formulation screening and assessment of Manufacturability of each candidate
- Banks of stable pools ready for single cell cloning
Lead to Manufacturability provides the data needed for selection of top product candidates to take forward into subsequent CMC development and clinical manufacturing, along with early access to quality preclinical materials in milligram quantities from stable pools to support early development needs. Wheeler’s CHO pool generation protocol, utilizing the ATUM Leap-In Transposase technology, produces high-titer pool materials that are highly representative of prospective clinical trial materials (CTM) — reducing risk of quality issues and allowing selection of leads that translate very well to manufacturing clinical supply. In addition, having the CHO pools from Work Package 1 and Work Package 2 in hand allows the subsequent CLD activities to be accelerated by months.
From sequence to toxicology material supply using CHO pool cultures
Drug Substance Supply (Non-GMP) for Toxicology Studies
Lead to Tox material supply provides an easy-to access and rapid approach to generating highly representative materials for Toxicology studies that leverage product quality attribute data, with the option to also leverage manufacturability assessments to identify the top product candidate for Tox material supply. Following the CHO pool generation in work package 1, with the option for top candidate selection from the Manufacturability studies performed in work package 2, the well-proven Wheeler process platform is used to scale-up the process to 40L, or as large as 500L, scale for product supply using Wheeler’s well-characterized process platform.
Work Packages
6.Rapid Toxicology Supply
Lead to Tox comprises the following deliverables:
- CHO pool expression of 4, or more, antibody candidates
- Product quality attribute assessment for multiple mAb candidates
- Up to 50 mg of Protein A purified material for multiple lead mAb candidates
- Formulation screening and assessment of Manufacturability of each candidate
- Banks of stable pools ready for single cell cloning
- 50 grams, or more, of purified drug substance for non-GMP toxicology study use
- Summary of Characterization Testing
Lead to Tox provides a very rapid supply of material for toxicology studies that leverages the power of the CHO pools and the Portable CMC® process and analytical platforms. This provides a robust and reliable path to Tox material supply allowing our clients to keep Toxicology studies off the critical path to the clinic.
From sequence to IND filing using CHO pool cultures
CGMP Drug Substance and Drug Product Supply
Wheeler Bio’s team of experts utilize cutting-edge technology and equipment to provide CGMP drug substance manufacturing with strict control standards and processes, ensuring consistent clinical drug substance supply. Due to our agile facility design and highly trained operational staff, Wheeler Bio can offer drug substance manufacturing services for antibodies and a variety of biologics that fall within industry standard equipment and production parameters. Our highly experienced manufacturing team can perform both non-cGMP engineering drug substance production runs as well as full CGMP production runs at a 50L to 500L scale for pre-clinical and clinical supply. Following production of drug substance at Wheeler’s facility, Wheeler will work with our drug product partners to manage the fill-finish supply and testing of drug product for our clients to facilitate the workflows to IND filing. Let Wheeler Bio handle all your small- batch manufacturing needs, regardless of your clinical development stage.
Work Packages
7.Clinical Material Supply
8.Drug Product Manufacturing
9.Support for CTD and Document Preparation
10.Tech Transfer
Wheeler’s Portable CMC® offerings deliver an open-source method for transfer to a reliable CDMO that will supply drug substance and drug product for clinical trials, supported by Wheeler’s preparation of drug substance process transfer package — consisting of process flow, control strategy, bill of materials, release testing, and specifications — that meet the requirements of an IND application. Additionally, we can support CDMO selection by leveraging partnerships with our drug substance and drug product CDMOs.
Lead to Clinic GMP material supply comprises the following deliverables:
- CHO pool expression of 4, or more, antibody candidates
- Product quality attribute assessment for multiple mAb candidates
- Up to 50 mg of Protein A purified material for multiple lead mAb candidates
- Formulation screening and assessment of Manufacturability of each candidate
- Banks of stable pools ready for single cell cloning
- 50 grams, or more, of purified drug substance for non-GMP toxicology study use
- Summary of Characterization Testing
- Analytical method development and qualification
- Formulation development
- Lab scale process platform verification and reference material generation
- CMC transfer package development
- CGMP released bulk drug substance and drug product
- Reference Materials and Release Testing Data
- Test Method Qualification Report (per test method)
- CMC Transfer Report with Risk Assessment (optional)
Lead to Clinic provides an easy-to-access rapid supply of material for toxicology studies, high-quality CGMP supply of drug substance and drug product for clinical studies, qualified DS release methods, and an open-source scalable manufacturing process with a CMC transfer strategy based upon Wheeler’s platform process and technical expertise. Clients benefit through early access to toxicology materials to initiate IND-enabling studies, production of CGMP materials with all documentation and stability data to support IND filing requirements, and the freedom and support to tech transfer the manufacturing process to any CDMO to prepare for late clinical phase and commercial phase manufacturing.