Unmatched Genetic QC Solutions for CGT Confirm

Solvias earned a Committed badge from EcoVadis in March 2025 following its first sustainability assessment, placing in the upper tier of over 100,000 companies. Since launching its ESG initiative in 2024, Solvias has set clear sustainability goals, calculated its carbon footprint, and developed a five-year action plan. The company plans to align with the Science Based Targets initiative (SBTi) to further advance its environmental commitments.

Peptide therapeutics have emerged as a significant frontier in the pharmaceutical industry, offering promise in treating countless conditions with high specificity and efficacy. This potential is reflected in the rapid growth of the global peptide therapeutics market, driven by advances in peptide synthesis and a deepening understanding of peptide biology. Despite their promising therapeutic applications, peptides present unique analytical challenges, particularly when employing High-Performance Liquid Chromatography (HPLC).

In 2025, Solvias opened a new Center of Excellence for Biologics and Cell and Gene Therapy in the vibrant Raleigh-Durham, North Carolina, establishing its second U.S. site as the North American hub for large molecule analytical services. The facility serves as a Center of Excellence for GMP testing of cell and gene therapies and other novel modalities. It reinforces Solvias’ capabilities in monoclonal antibody testing across all development stages from preclinical through commercial release.

Susan M. De Paul, PhD is the Team Leader of the Solid-State Development group,at Solvias AG in Switzerland. Her team specializes in contract research in,the field of solid-state development of pharmaceuticals. This includes, discovering crystalline forms (polymorphs) of drug substances, crystallizing, multi-component systems (salts, co-crystals), characterizing the physicochemical, properties of these solid forms to guide preformulation, selecting,the best solid form for development, and developing a crystallization,process from the mg to kg scale.

Cergentis enables Solvias to provide customers with proprietary technology and knowledge steeped in fast-evolving genomic techniques that support effective decision-making and R&D program design.

Is you product adulterated? Christopher Latendresse, PhD and Christopher McGee, PhD, Team Leaders in Extractable/Leachable Chemistry at Solvias USA, LLC, lead a discussion on extractable and leachable considerations for biopharmaceutical manufacturing processes. They will discuss the use of polymeric/elastomeric materials or single-use systems that are commonly adapted by biopharmaceutical developers and manufacturers, including those in the cell and gene therapy space. Process equipment-related leachables (PERLs) can adulterate your drug substance or drug product and have become a recent focal point in E&L submissions/regulatory review. These compounds may be reactive, additive, or absorptive. They could have an impact on critical quality attributes including the safety, efficacy, and stability of...

New partnership will open access to biocatalysis offerings like production of biocatalysts, customer-specific solutions to questions of chemo-biocatalytic synthesis, process development and piloting.

Learn more about best practices for genetic characterization and QC in cell line development.  

Daniel Galbraith shares insights from the forefront of drug development, including the complexities of development and commercialization, the financial dynamics of new therapies and changing regulatory landscapes.   

Cell-based bioassays (CBBAs) are an essential tool for drug development, from preclinical through commercialization and are crucial for monitoring drug manufacturing processes and ensuring the safety, efficacy and potency of pharmaceutical products. These products, particularly cell and gene therapeutics and advanced biologics, are inherently complex. Therefore, CBBAs must be tailored to suit each program. Choosing the best methods for each modality and understanding the desired endpoints are critical to designing successful assays and keeping your program on track. This webinar will explore essential strategies for designing and developing successful CBBAs tailored toward the development of advanced therapeutics.

Reginald Clayton, PhD, Director of Field Development at Solvias breaks leads this technical discussion on Cell-Based Potency Assays for Quality Control of Cell and Gene Therapies.

Christoph Lederer, Head of Operations; Large Molecules & ATMP, unpacks the key analytical challenges in Antibody-Drug Conjugate (ADC) development and how to overcome them. From antibody integrity and linker stability to payload potency and DAR — learn how advanced analytical strategies can support your CMC efforts from early development to commercialization.

Solvias CEO, Archie Cullen describes the Solvias commitment to offering first-time, on-time analytical services and the state of the biopharmaceutical industry.

As demand for self-administered therapies accelerates, autoinjectors, formally known as automated needle-based injection systems (NIS-AUTO), are playing an increasingly central role in modern medicine. These devices offer convenience, improve adherence, and support patient autonomy, while also easing the burden on healthcare systems. However, their dual role as both drug and device introduces a unique set of regulatory and performance challenges that must be addressed from early development through to commercialization.

Cell and gene therapies (CGTs) are transforming the therapeutic landscape, offering new hope for patients with previously untreatable conditions. However, the path to market for CGTs presents significant challenges. With CGT studies expanding rapidly, regulatory scrutiny has intensified, leading to an increase in clinical holds, many of which are due to deficiencies in Chemistry, Manufacturing, and Controls (CMC). Potency testing is among the most complex CMC requirements. Clinical holds related to potency assay issues can cause severe delays and financial setbacks, making early assay developmen...

 the integrity of container closure systems (CCS) is a critical component of sterility assurance for parenteral products. Compromised CCS can lead to microbial ingress, contamination, and significant patient safety risks, with past incidents resulting in product recalls and, in severe cases, widespread harm. Container Closure Integrity Testing (CCIT) plays a pivotal role in mitigating these risks, ensuring compliance with regulatory standards and safeguarding patient safety throughout a product’s lifecycle.

This white paper delves into regulatory requirements, modern CCIT methodologies, and practical strategies for selecting, validating, and optimizing testing methods. These insights are designed to help drug developers ensure product integrity, meet compliance standards, and uphold the highest levels of patient safety.

Extractables and Leachables (E&L) studies are critical analyses conducted when developing a pharmaceutical product. These studies assess the potential for chemical compounds to migrate from containers, closures, and other packaging into the drug product. Therefore, E&L assessments are vital to ensure patient safety and consistent product quality. E&L studies are often underappreciated in the drug development process. While a generic, one size fits all approach may provide a superficial understanding of potential chemical interactions, it frequently falls short in identifying all E&Ls. In this white paper, we cover the risks and true cost of inadequate E&L testing.

In the dynamic landscape of pharmaceutical and biopharmaceutical manufacturing, single-use systems (SUS) have revolutionized processes by offering flexibility, efficiency, and cost-effectiveness. However, ensuring the safety and quality of pharmaceuticals manufactured using SUS requires rigorous testing and adherence to industry standards.
The United States Pharmacopeia (USP) Chapter <665> "Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products" provides crucial guidance on the analytical testing of SUS to mitigate the risks associated with extractables and leachables (E&L). Chemically characterizing and qualifying plastic components used in manufacturing is certainly an inevitable task. Mandatory c...

Amorphous Solid Dispersions (ASDs) are a transformative approach to improving bioavailability in drug formulations. In ASDs, the drug doesn't form well-defined crystals, but instead exists uniformly dispersed in the polymeric carrier in a sub-divided state, ideally molecularly dispersed. Due to this, it forms a disordered, non-crystalline state. This innovative technique holds great promise for enhancing drug solubility, ultimately leading to improved bioavailability. Despite their effectiveness in addressing therapeutic limitations, ASD formulation creates challenges, in particular the risk of crystallization and stability issues. Therefore, ASDs require knowledgeable testing to ensure consistent product quality and efficacy throughout its lifetime.

Nitrosamines are a group of chemical compounds known for their carcinogenic properties. These compounds can unintentionally form as impurities during the manufacturing of various substances, including active pharmaceutical ingredients (APIs). With the FDA and global health authorities strengthening regulatory requirements after several prominent recalls of widely used medications, the spotlight on nitrosamines has intensified.


For pharmaceutical companies, the stakes are high. The presence of nitrosamines in drug products on the market can trigger recalls, causing severe financial and reputational damage. Moreover, during the approval process of a new drug, insufficient data on nitrosamines can lead to costly delays. Proactively managing nitrosamine risks is an imperative for drug developers to ensure compliance with regulations, maintain product safety, and uphold public trust.

Learn more about our analytical solutions that span the entire product lifecycle

Antibody-Drug Conjugates (ADCs) represent a revolutionary approach in cancer treatment by combining the selectivity of monoclonal antibodies with the potency of cytotoxic drugs. However, the unique complexity of ADCs— comprising an antibody, a linker, and a cytotoxic payload—introduces a range of analytical challenges.

This white paper explores these critical challenges, focusing on the characterization, stability, and potency of each ADC component. It highlights the need for comprehensive and customized analytical strategies to ensure the safety, efficacy, and consistency of these therapeutics. From ensuring antibody integrity and linker stability to accurately assessing payload potency and drug-to-antibody ratios, each step demands precision to navigate the intricate pathways of ADC development.

With decades of experience, Solvias offers comprehensive excipient and raw material testing, as well as DS and DP release testing for small molecules, biologics, and cell and gene therapies. We support you in defining critical quality attributes and selecting the optimal, phase-appropriate testing strategy to ensure timely and reliable release.

At Solvias, we combine deep scientific expertise with powerful LC-MS-based solutions to help you confidently navigate the complexity of oligonucleotide analysis from development to release.

Solvias provides rapid nitrosamine screening, development and cGMP validation of control methods for small nitrosamines, nitrosamine drug substance related impurities (NDSRIs), and any other genotoxic impurities with unparalleled sensitivity and selectivity.

At Solvias we offer rigorous microbiology testing protocols to uphold the highest safety standards

Stability studies are critical for ensuring the quality, safety, and efficacy of therapeutics. While vital, these studies can be resource-intensive and time-consuming. Solvias streamlines this process, offering comprehensive stability studies in accordance with ICH guidelines.With our deep expertise, large storage capacity, and flexible approach,we deliver fast and accurate results.

At Solvias we offer comprehensive impurity & contamination control services, enhancing product safety, efficacy, and quality through advanced HRAM mass spectrometry,deep expertise, and risk-based approaches.

Navigate the complexity of mAb manufacturing with Solvias’ comprehensive array of innovative testing solutions to ensure the quality, safety, and effectiveness of your product.

Solvias offers custom E&L programs for multiple modalities that conform to the latest regulatory guidelines.

Cell and gene therapies (CGT) are complex and technically demanding to manufacture. Solvias help syou overcome every challenge in CGT analytical testing in a cGMP-compliant environment.

Comprehensive CBBA Capabilities: Solvias has capabilities spanning the entire product lifecycle, from late-stage research, pre-clinical development through commercial release, with particular expertise in potency, stability, and safety assessment of biologics and cell & gene therapies.We understand that cell-based bioassays are unique to each product and our extensive experience allows us to rapidly develop, transfer, and validate cell-based assays in compliance with ICH Q2(R2), ICH Q14, and USP<1033/1210>.

Navigate the complexity of mAbs and ADCs withSolvias’ comprehensive array of innovative testingsolutions to ensure the quality, safety, andeffectiveness of your product.

Comprehensive Peptide Capabilites: Peptides hold immense therapeutic promise, yet their development is challenging due to theirinherent complexity and diverse physicochemical properties. This complexity demands a plethora ofanalytical techniques to fulfill the stringent regulatory requirements. Solvias addresses these challenges with comprehensive analytical capabilities, leveraging our deep expertise, experience, andstate-of-the-art technology to keep your development on schedule and within budget.

Learn more about our testing services for cell and gene therapies and other novel modalities offered at our Center of Excellence in Research Triangle Park, North Carolina.