DFE Pharma

Stability is one of the defining considerations in biologics development. From mAbs and LNPs to cell and gene therapies, these complex modalities demand formulation strategies that protect sensitive structures through processing, freezing, lyophilisation, and storage. Excipient choice can make a meaningful difference, because stability matters. BioHale® Sucrose and Trehalose Dihydrate are developed to support biologic formulations where consistency and stability are essential. Helping formulation teams move forward with confidence — from early development to commercial readiness. Explore stabilization approaches for modern biologics.

Biologics are transforming medicine—and raising the bar for excipients and formulations. As therapies become more complex, the need for excipients that deliver stability, consistency, quality, and reliability is becoming more an more important, With BioHale®, DFE Pharma combines high-quality excipients with scientific expertise to help biopharma teams develop robust biologic formulations and turn complexity into progress. Because advancing biologics starts with the right foundation.

Even more in biologics than any other formulation, excipients shape performance, manufacturability, and patient access. Their strategic impact becomes clear when embedded in platform technologies that enable new therapies and address unmet needs. As a result, excipient selection becomes an integral part of development strategy. With BioHale®, DFE Pharma supports formulation approaches designed for today’s biologics requirements. Because strong formulations are built on more than active ingredients alone.

The growth of GLP‑1 therapies highlights how quickly formulation expectations are evolving. As peptide-based and biologic therapies advance, developers are looking for approaches that support stability, consistency and scalable performance. High-quality excipients play an important role in enabling this. With BioHale®, DFE Pharma combines excipient quality, advanced purification and European manufacturing expertise to support demanding applications. Trough our INTO - Inhalation Together partnership, we have developed in-vitro and in-vivo data using Trehalose, which supports the development of GLP formulations. Enabling formulation approaches designed for where biologics are heading next.

As microplastics regulations evolve, excipient selection may increasingly require regulatory assessment alongside formulation considerations. The good news? Many widely used excipient chemistries may fall outside the regulatory scope when: - Their material properties are well understood - Exclusion criteria are properly assessed - Testing evidence is generated where needed DFE Pharma’s polymer portfolio is built on established excipient chemistry and backed by regulatory-relevant data, helping you: ✔️ Reduce regulatory complexity ✔️ Avoid REACH microplastics reporting obligations Stay ahead of regulatory expectations, without compromising performance. Explore our portfolio to see which materials can be used while staying fully compliant: https://lnkd.in/ez-tUD_W

Can you demonstrate that your materials fall outside microplastics scope? Under EU REACH, exclusions are not assumptions, they must be demonstrated. That means having: •Clear, grade-specific documentation •Evidence aligned with relevant REACH appendices and explanatory guide •Fit-for-purpose solubility and biodegradability data Without this, pharmaceutical excipients may trigger reporting obligations. DFE Pharma provides structured justification documentation for all excipients in the portfolio to help support your assessment. Because clarity starts with data: https://lnkd.in/ez-tUD_W