In 2025, Crystal Pharmatech marked its 15th year of operation. Over the past decade and a half, the company has grown alongside the global biotech industry—navigating increasing complexity, uncertainty, and rapid innovation with a consistent focus on scientific rigor and long-term partnership.

In an environment where speed often competes with quality, Crystal Pharmatech has remained disciplined. Its work is grounded in strong fundamentals, data-driven development, and a commitment to getting development right the first time.

Building Strong Scientific Foundations

Guided by its First-Time-Right philosophy, Crystal Pharmatech designs solid-state and formulation strategies tailored to each molecule’s unique profile. Through close collaboration with biotech and pharmaceutical partners, the company supports programs from early discovery through commercialization—helping reduce risk and enable more confident development decisions.

Expanding the Crystal Platform

Throughout 2025, Crystal Pharmatech continued to strengthen its integrated platform, expanding beyond small molecules into biologics and nucleic acid therapeutics while applying the same science-first discipline across every domain.

Small Molecules | Solid-State & Formulation

• Expanded characterization capabilities with Renishaw inVia Raman microscopy, complementing existing XRPD tools to support polymorph research, formulation analysis, and reverse engineering.

• Advanced microcrystal structure determination through strategic collaboration, with additional in-house capability planned for 2026 to accelerate confident form and structure assignment for challenging samples.

• Strengthened quality systems and external recognition through CNAS reaccreditation and scope expansion, including polymorph quantification, hygroscopicity, and dynamic vapor sorption (DVS).

• Enhanced global formulation manufacturing and QC capabilities through the Canadian site, Candoo Pharmatech, with expanded GMP production suites and QC laboratories supporting reliable, on-time delivery.

• Supported partners through critical regulatory milestones, successfully completing multiple GMP audits in 2025.

Crystal Bio Solutions | Biologics CMC, Bioanalysis & QCP

• Launched and scaled the U.S. bioanalysis platform by integrating GLP bioanalysis with biomarker assays, large-molecule characterization, and CMC analytics.

• Strengthened support for biosimilar and innovator biologics programs through enhanced structural and functional characterization and comparability workflows.

• Continued maturation of GLP and GCLP quality systems, maintaining strong audit performance for global sponsors.

• Expanded Quantitative Clinical Pharmacology (QCP) capabilities with dedicated leadership to support dose rationale, PK/PD strategy, and data-driven clinical decision-making.

Crystal NAX | Nucleic Acids & Delivery

• Introduced Crystal NAX as a dedicated nucleic acid platform focused on delivery, development, and CMC execution for next-generation therapeutics.

• Advanced mRNA and LNP delivery capabilities through continued investment in formulation design, analytics, and phase-appropriate development strategies.

• Expanded enabling support for in vivo CAR-T programs, bridging early research through translational readiness.

• Strengthened GMP manufacturing support for IIT and early clinical programs, supporting faster progression with clearer quality control.

Looking Ahead

As Crystal Pharmatech moves forward, its purpose remains clear:

Mission To remove critical development barriers and accelerate the delivery of innovative medicines to patients worldwide.

Vision To be a trusted long-term scientific partner across every niche it serves.

Across the Crystal platform, one principle connects all activities: respect for science, continuous improvement, and accountability to partners.

The company thanks its clients, collaborators, and teams for their continued trust and partnership as the next chapter begins.