The Benefits of Portable CMC™

PORTABLE CMC™

Speed, efficiency, predictability, and freedom

Wheeler Bio is changing the CDMO model with its Portable CMC™ platform, central US location, and steadfast commitment to collaboration, data transparency, and Pharma 4.0. Wheeler Bio’s platform is delivering a new tier of biomanufacturing quality, clinical timelines, and customer experience.

Portable CMC™ is a bundle of innovative services that accelerates the path to IND. With Portable CMC™, we simplify the connection between early drug discovery and clinical manufacturing — standardizing and democratizing the discovery to IND process.

Using state-of-the-art tools, technologies, data science and original methods for drug substance manufacturing and testing, Portable CMC™ provides an efficient bundling of three useful CMC development services — Lead Selection, Clone Selection, and CDMO Selection.

When integrated with antibody discovery processes, innovators benefit from shorter timelines, reduced risk of selecting lead molecules and processes that do not translate well into manufacturing, reduced risk of IND delays, increased momentum during technology transfer, and stronger negotiation positions with enterprise providers.

A New Tier of Customer Experience

Predictable yields, timelines, and budgets

Reduced regulatory risks during IND filings

A standardized, freely transferable suite-ready manufacturing CMC package

Open-source drug substance process with the freedom to go to any manufacturer

Fixed fees, cost-efficiency, and transparent collaboration

Find out more about how you can get to IND faster with Portable CMC™ and a CRO partnership

Game Changing Partnerships

Through early collaboration with tech providers, DataHow and Synthace, Wheeler was able to build Portable CMC™ on top of an integrated, end-to-end digital biomanufacturing platform. Zurich-based DataHow specializes in data analytics and process modeling, offering digital solutions for process screening, monitoring, optimization, control, and scale-up. London-based Synthace provides a software layer called Life Sciences R&D Cloud that seamlessly automates experimentation and insight sharing.

Integrating these tools with Wheeler’s proprietary drug substance methods offers Wheeler’s emerging biotech partners access to powerful, predictive bioprocess modeling, enabling deeper scientific insights from each experimental run and overall reduction in effort, risks and costs in process development and manufacturing. Customers enjoy the benefits of reduced risk of IND delays, increased momentum during technology transfer, and stronger negotiation positions with enterprise providers.

From Discovery to IND

Scope of Portable CMC™ Services

Lead Selection

Lead Selection provides early access to quality preclinical materials in milligram and gram quantities from stable pools to support customer R&D needs. With Wheeler’s high-producing cell lines along with transposon-based gene delivery, stable pools generate materials that are highly representative of prospective clinical trial materials (CTM) — reducing risk of quality issues and selecting leads that do not translate well to manufacturing.

Deliverables of Lead Selection include:

Up to five banks of pools for multiple mAb candidates
Up to 50 mg of Protein A purified material for multiple lead mAb candidates (shake flask format)
Analytical Testing Report (for mg quantities)
Up to 20 g of fully purified material for multiple mAb candidates (bioreactor format)
Certificate of Testing (for gram quantities)
Process Feasibility Report

Clone Selection

Clone Selection produces stable clones that are ready for GMP master cell bank preparation. Wheeler utilizes next-gen cell line development technologies from Solentim and Ambr® for confidence in clonality, rapid decision-making, and clone selection. Manufacturability assessments with Ambr® 250 and cell line stability studies provide clone validation and line-of-sight to an optimized drug substance manufacturing process. To realize the highest efficiencies and fastest timelines, Clone Selection is performed in parallel with Lead Selection.

Deliverables of Lead Selection include:

24-vial Development Cell Bank (“DCB”) for the top four clones for multiple mAb candidates
Cell Line History and Development Report for each DCB
Stable Clone Cell Line Development Report
Manufacturability Assessment and Lead Clone Selection Report for the final DCB
Summary of Characterization Testing

CDMO Selection

CDMO Selection delivers an open-source method for preparation of drug substance — such as process flow, control strategy, bill of materials, release testing, and specifications — that meets the requirements of the IND application. CDMO Selection also supports the Request for Proposal process to facilitate CDMO engagement.

CDMO Selection activities include:

Analytical method development
Formulation development
Lab scale process verification and reference material generation
Analytical method qualification
CMC transfer package development
CDMO RFP development including generating and issuing Request for Proposal (“RFP”) to three (3) CDMOs, and the review of RFP responses from three (3) CDMOs.
Assist in developing and reviewing services agreements between Customer and CDMO as needed
Assist in CDMO Quality audits as needed
Participate in CDMO site visits as needed
Prepare a CDMO comparative analysis based on criteria including but not limited to: CDMO transparency, accessible capacity, technical expertise, drug substance release timeline, parallel drug product capability, risk-based approach, Quality and Regulatory know-how

CDMO Selection key deliverables are:

Test Method History Report (per test method)
Formulation Development History Report
Process Verification Assessment
Reference Materials
Reference Materials Release Testing Data
Test Method Screening Report (per test method)
Test Method Qualification Report (per test method)
CMC Transfer Report
Risk Assessment Report
CMC Transfer Plan
CDMO Comparative Analysis Report

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