Altru-CON™ High-Concentration Formulation Platform
The COVID-19 pandemic and a growing focus on proactive health management have accelerated demand for self-administered therapies, particularly biologics designed for convenient at-home use. As a result, there is growing interest in formulation and delivery solutions that enable subcutaneous administration rather than traditional intravenous infusions in clinical settings. In 2024, the global self-administered drug market was valued at $22.79 billion and is projected to grow at a CAGR of 10.3% through 2030, reflecting strong demand for therapies that enhance patient convenience.
However, transitioning biologics to subcutaneous delivery introduces significant formulation challenges that can affect performance and production. Injection volumes are typically limited to 1–3 mL, requiring higher-concentration formulations to deliver therapeutic doses while maintaining acceptable injection volumes and dosing frequency.
Developing high-concentration protein and monoclonal antibody (mAb) formulations—often exceeding 150 mg/mL—can pose significant hurdles due to viscosity, stability, and manufacturability. At Altruist Biologics, Altru-CON™, our high-concentration formulation technology platform, addresses these challenges through a systematic, science-driven formulation approach that enables the development of stable high-dose biologics suitable for patient-friendly delivery formats.
Leveraging a high-throughput screening approach and an intelligent excipient system incorporating more than 30 excipient combinations, the platform significantly improves efficiency in formulation screening and process optimization, substantially shortening development timelines and translating our commitment to rapid response and high-quality delivery into every project schedule.
To date, Altru-CON™ has supported multiple clients in overcoming formulation concentration bottlenecks, achieving high-concentration formulations of up to 200 mg/mL, enabling greater therapeutic payloads within a single injection and offering improved clinical solutions.
Building on this foundation, we further advanced the integration of high-concentration formulation technology with hyaluronidase-enabled approaches, enabling innovative co-formulation strategies and successfully establishing viable pathways for high-dose subcutaneous administration. This directly addresses the growing industry demand for subcutaneous biologics—enhancing patient experience while providing flexibility for future transitions from intravenous to subcutaneous delivery.
Through full-spectrum capabilities spanning developability assessment, process development, and commercial manufacturing, Altruist Biologics empowers partners to build end-to-end competitiveness from early R&D to market access.
A Strategic Approach to High-Concentration Formulation
Starting with a rigorous, stepwise methodology, Altruist Biologics’ platform process identifies potential formulation bottlenecks at the outset to mitigate risk and prevent delays, while also customizing workflows for different modalities to address the key aspects of formulation development.
A critical aspect of the process is addressing viscosity challenges and aggregation risks. Through Altru-CON™, we are able to apply the following technology-driven solutions:
- A high-throughput formulation screening to enable rapid evaluation of more than 40 buffer systems, covering virtually all industry-standard buffer categories.
- Intelligent optimization of over 30 functional excipients to mitigate non-specific protein–protein interactions, effectively reducing viscosity and enhancing stability.
By applying this decision-tree approach, Altruist Biologics ensures the development of high-concentration formulations that are robust, scalable, and meet commercial quality standards.
Proven Scientific Expertise & Comprehensive Capabilities
We have established a fully integrated service offering that spans early research, formulation and process development, pre-filled syringe manufacturing, and subsequent commercial production, supporting multiple molecular formats including monoclonal antibodies, bispecific antibodies, nanobodies, antibody peptide conjugates, and fusion proteins.
This end-to-end capability ensures that every step—from laboratory to market—is supported with greater continuity, control, and efficiency, accelerating product launch timelines and bringing therapies closer to patients in need.
Experienced Development Team
Altruist’s formulation development team has extensive experience in high-concentration projects. Approximately one-third hold PhDs and two-thirds hold master’s degrees, with some team members bringing experience from leading global biopharmaceutical companies and top-tier CDMOs.
Advanced Research Infrastructure
Our laboratories are equipped with a range of tools to support high-throughput screening under high-concentration conditions.
- Micro-viscometers
- Dynamic light scattering (DLS)
- Differential scanning fluorimetry / static light scattering
- Microfluidic imaging particle analysis
- Tensile testing systems
- Microplate readers
For stability studies, we utilize BINDER temperature/humidity chambers and IKA-controlled orbital shakers. We also operate small-scale vial and prefilled syringe (PFS) filling lines to support technology transfer and change management for high-concentration formulations.
Structured High-Efficiency Workflow
Our high-throughput development process includes eight stages:
- Developability assessment
- High-concentration feasibility evaluation
- pH-Buffer system screening
- Excipient screening
- Formulation confirmation study
- Drug product process development
- In-use stability studies
- Force degradation studies
Concentration ranges span 100–200 mg/mL, ensuring low viscosity and high stability, with the capability to complete high-concentration IND submissions within nine months from cell line development.
Commercial Manufacturing Capabilities
Altruist possesses comprehensive commercial manufacturing capabilities for high-concentration formulations, including vial filling, prefilled syringe filling, and auto-injector assembly. We have successfully supplied clinical material for over 40 high-concentration products and supported commercial supply for two approved high-concentration products.
During clinical development, drug delivery formats often evolve—for example, transitioning from vials to prefilled syringes or auto-injectors. Altruist brings extensive experience supporting these container closure system changes, providing systematic development and regulatory expertise to ensure smooth packaging transitions that align with both clinical requirements and patient needs.
Differentiated Innovation For High-Concentration Success
Developing high-concentration biologics requires a differentiated, data-driven approach that integrates early molecular assessment, risk-based screening, and advanced formulation expertise to enable successful subcutaneous delivery and long-term product stability.
Early-Stage Molecular Risk Assessment
At project initiation, we define high-concentration development requirements and evaluate potential risks early in the molecule’s lifecycle. Leveraging analytical methods established during early molecular research, we systematically assess candidate molecules for key developability attributes, including non-specific self-interactions, thermal stability, aggregation propensity, and colloidal stability. This early-stage screening helps identify potential formulation risks and increases the likelihood of successfully advancing molecules suitable for high-concentration development.
Risk Matrix–Driven Feasibility Assessment
During developability studies, viscosity and accelerated stability risk matrices are applied to evaluate formulation feasibility and guide development strategy. As part of buffer and excipient screening, a comprehensive, data-driven approach is used to efficiently identify optimal formulation conditions:
- Multi-parameter evaluation of more than 40 buffer systems supports rapid identification of conditions that enhance protein stability.
- Intelligent combinations of 30+ excipients are assessed to mitigate non-specific protein interactions and improve overall formulation robustness.
- Viscosity is evaluated across more than 30 formulation conditions within accelerated timelines, enabling rapid selection of candidates suitable for high-concentration delivery.
This structured, risk-based workflow enables efficient identification of stable, manufacturable high-concentration formulations suitable for subcutaneous administration.
Case Studies
Conclusion
Driven by increasing demand for patient-friendly delivery formats, high-concentration therapeutic antibodies are a rapidly growing segment of the biopharmaceutical market. Achieving these concentrations, however, introduces significant formulation challenges related to viscosity, stability, and manufacturability, particularly for complex proteins and monoclonal antibodies. To address these complexities, Altruist Biologics developed the Altru-CON™ platform, designed to enable robust and stable high-concentration formulations that support efficient manufacturing and optimal product performance.
The Altru-CON™ platform applies a comprehensive, science-driven approach to formulation development, beginning with early feasibility assessment to evaluate whether target concentrations can be achieved while maintaining stability and manufacturability. Key formulation parameters—including surfactant selection, buffer systems, and pH—are then optimized, followed by comprehensive excipient screening to minimize degradation and mitigate viscosity issues.
By integrating advanced analytical tools with data-driven formulation strategies, Altruist Biologics helps reduce development risk and enable scalable, high-performance formulations tailored to the evolving needs of biologic drug development.