Sponsored by AlfatestLAB

With GMP-certified and ISO/IEC 17025-accredited services, Alfatestlab helps pharmaceutical companies understand how powders, particles, liquid dispersions and nanosystems behave across development and quality control, turning complex materials questions into clear, decision‑ready analytical insight.

Pharmaceutical development today is increasingly shaped by the behavior of complex materials, from poorly soluble APIs and engineered particles to innovative nanosystems and advanced delivery formats. Understanding how these systems behave under real conditions is essential for robust formulations, efficient manufacturing and confident regulatory submissions.

Alfatestlab is a specialized contract laboratory focused on advanced physical characterization rather than general-purpose testing. Certified GMP and accredited ISO/IEC 17025, the laboratory combines a comprehensive technology platform with deep application expertise to support pharmaceutical companies from early-stage research through to quality control, stability studies and troubleshooting.

Instead of simply providing numbers on a certificate, Alfatestlab works with customers to interpret results in the context of product performance, regulatory expectations and process constraints. This consultative approach is particularly valuable wherever standard methods and generic laboratories are not enough to answer complex questions about solid-state forms, particle properties or the stability of sophisticated formulations.

For many oral solid dosage forms and inhalation products, the physical state of the API and excipients can make the difference between a robust formulation and a poorly performing one. Alfatestlab offers an integrated suite of solid-state characterization services, including X-ray powder diffraction (XRPD) for polymorphism and crystallinity, MDRS for single ingredient particle size and shape within complex solid and liquid formulations, thermal analysis techniques such as DSC and TGA, water sorption studies, BET surface area and porosimetry.

These techniques help pharmaceutical teams map the relationship between solid form, process conditions and product behavior, supporting activities such as preformulation, salt or polymorph selection, form screening and stability assessment. By generating reliable, regulator-ready data, Alfatestlab enables companies to reduce risk in critical decisions and maintain control as projects move toward commercialization.

Particle properties are critical to blend uniformity, compression, dissolution, flowability and aerosol performance. Alfatestlab provides advanced particle characterization covering both dry and wet systems, with laser diffraction for particle size distribution, image analysis and Morphologically Directed Raman Spectroscopy (MDRS) to link size, shape and chemical identity, and dedicated methods for spray and aerosol droplet size distribution (DSD).

These capabilities are particularly relevant for inhalation therapies, controlled-release formulations and complex blends, where understanding particle size, morphology and agglomeration is crucial. By combining multiple techniques, the laboratory can help identify whether a problem arises from the formulation itself, the manufacturing process or specific raw materials, enabling more targeted corrective actions.

As more pharmaceutical products take the form of suspensions, emulsions, semi-solids and novel liquid-based systems, characterizing their physical stability has become a key requirement. Alfatestlab supports this space with services for liquid dispersions, including particle size and shape analysis in suspensions, creams, gels and sprays, zeta potential for electrostatic stability, surface tension, and rheological profiling.

These tools help formulators understand how factors such as droplet size, interfacial properties and viscosity influence sedimentation, creaming, phase separation or caking. The result is a clearer view of which formulation and process parameters actually control stability, allowing teams to design more robust products and justify shelf-life decisions with solid data.

For development teams working with nanomedicines, lipid nanoparticles or extracellular vesicles, conventional testing services are often not enough. Alfatestlab has invested in characterization capabilities dedicated to colloidal and nano-sized systems, including dynamic light scattering (DLS), nanoparticle tracking analysis (NTA) for size and

In the case of extracellular vesicles (EVs), the laboratory is equipped with a state-of-the-art technological platform (Nanosight, Leprechaun, Everest Biolabs) to support key parameters such as size, concentration, phenotype, cargo, membrane integrity and purity.

Beyond its analytical portfolio, Alfatestlab offers a strong focus on method development, optimization, transfer and GMP validation for physical characterization techniques. The laboratory supports pharmaceutical companies that need to implement robust methods at manufacturing sites or within quality control, while maintaining consistency with R&D data and regulatory expectations.

The team also acts as a problem-solving partner in troubleshooting projects, particularly when issues stem from powder behavior, unexpected solid-state changes, instability in dispersions, or unexplained variability in process performance. This service is especially effective thanks to deep instrumental and regulatory expertise, an extensive library of application case histories, and the ability to combine multiple characterization tools within a methodical, orthogonal, and multivariate investigative approach. By moving systematically from symptoms to root cause, Alfatestlab helps customers resolve complex analytical challenges as quickly and efficiently as possible.

Compliance with ICH Q2(R2) is a core objective from the earliest development stages. For this reason, all methods delivered by Alfatestlab are designed to be robust and precise from the outset, and are systematically supported by a system suitability test specifically developed during the validation study. Once the analytical method is fully validated, Alfatestlab remains the right partner to deliver quick and accurate batch release certificates of analysis.

Across all these activities, Alfatestlab positions itself as a specialist in advanced material and particle characterization rather than a generalist testing provider. This focus allows the laboratory to invest in niche technologies, build deep domain expertise and offer truly consultative support to pharmaceutical clients facing increasingly complex formulation and manufacturing challenges.

For pharmaceutical companies working with challenging solids, sophisticated liquid systems, nanoscale carriers or innovative delivery routes, partnering with a dedicated characterization laboratory can be a decisive advantage. Alfatestlab’s combination of GMP and ISO/IEC 17025

credentials, advanced technology clusters and application-driven expertise is designed to provide that edge-turning complex materials behavior into clear, reliable guidance for development and quality decisions.

1. Biffa internal savings data, average saving (January - August 2023)
2. Nisbets internal savings data, average saving (January – September 2023)
3. Compliance365 internal data, average  savings
4. HEINEKEN UK data, Calculations based on SmartDispense® active accounts each year since 2015 with 10 lines
5. Independent test results based on subterranean and ground floor pub cellars of varying sizes
6. Independent test results based on subterranean and ground floor pub cellars of varying sizes