Subcutaneous delivery performance

Enabling More Predictable Subcutaneous Drug Delivery

RayBalance is developing a non-reformulation platform intended to help pharmaceutical and device partners address absorption variability at the subcutaneous administration site.

Illustrative concentration-time profiles showing broad variability across patients, molecules, and administration-site conditions, with conceptual narrowing toward a target concentration range
The Challenge

Subcutaneous Delivery Still Has a Variability Problem

Subcutaneous delivery offers clear advantages for patients, providers, payors, and pharmaceutical companies. It can reduce infusion burden, support home administration, improve convenience, and extend the commercial value of important therapeutic franchises.

However, SC delivery performance is not determined by the drug product alone. Absorption may be influenced by the local administration environment, injection-site variability, patient physiology, disease-state factors, molecule characteristics, and delivery workflow.

  • SC products may show variable absorption across patient populations.
  • IV-to-SC conversion programs may face bioavailability or exposure-distribution constraints.
  • Follow-on products may struggle to differentiate without changing the drug.
  • Reformulation can create CMC, stability, regulatory, manufacturing, and timing burden.
Illustrative schematic showing low, target, and above-target exposure profiles relative to a narrow target range
RayBalance Platform

A Non-Reformulation Approach to SC Delivery Performance

RayBalance is developing a drug-adjacent, administration-site platform to support more predictable subcutaneous absorption while preserving a partner’s existing drug product and development strategy.

The platform focuses on administration-site conditions that contribute to absorption variability, with the goal of supporting more predictable delivery performance.

Partner Drug Product Assets

  • Molecule
  • Formulation
  • Excipient system
  • Container closure
  • Regulatory strategy

RayBalance Administration-Site Platform

  • Non-reformulation
  • Drug-adjacent
  • Administration-site focused
  • Partner-specific evaluation

Partner-Specific Evidence Path

  • Feasibility assessment
  • PK evaluation where appropriate
  • Usability and integration planning
  • Regulatory alignment
Partner Opportunities

Built for Pharmaceutical, Biosimilar, and Device Partners

RayBalance is focused on opportunities where subcutaneous absorption performance, variability, administration workflow, lifecycle strategy, or IV-to-SC transition presents a meaningful development or delivery challenge.

Follow-On / Biosimilar Differentiation

Evaluating whether administration-site enhancement can provide a differentiated performance layer while preserving the drug product.

Lifecycle Strategy

Evaluating non-reformulation approaches that may support product differentiation, administration performance, and long-term franchise value.

IV-to-SC Transition

Administration-site enhancement may support greater absorption predictability and practical SC transition strategies.

Delivery-System and Device Partners

RayBalance is evaluating collaborations where administration-site enhancement could complement existing or in-development delivery platforms.

Injectors
On-body devices
Pumps
Connected systems
Development Approach

Evidence-Driven and Partner-Specific

RayBalance is building its platform through a staged evidence program focused on administration-site biology, absorption-relevant endpoints, safety, usability, and molecule-specific pharmacokinetic evaluation where appropriate.

Detailed technical information, proprietary methods, device configuration, treatment parameters, and molecule-specific development plans are disclosed only under appropriate confidentiality protections.

1

Strategic Fit

Understand the partner’s product, opportunity, and development context.

2

Feasibility Assessment

Evaluate potential alignment with the administration-performance challenge.

3

Evidence Plan

Define the right evidence strategy for the partner opportunity.

4

Molecule-Specific Evaluation

Conduct PK and other evaluation where appropriate.

5

Regulatory and Integration Alignment

Align on regulatory strategy and delivery-system integration.

Contact

Connect with RayBalance

RayBalance is interested in discussions with pharmaceutical companies, biosimilar manufacturers, medical device companies, and strategic partners evaluating subcutaneous delivery performance, lifecycle strategy, or IV-to-SC transition opportunities.

Please do not submit confidential information through this form.

Business Development Inquiries

ddrinan@raybalance.com

3830 Valley Centre Drive, STE 705-224
San Diego, CA 92130

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