Solid-State Development

Solid-State Development
Product Description

Solvias provides an integrated and comprehensive approach to solid-state development – from systematic salt, co-crystal, and polymorph screening to controlled scale-up of the crystallization process, all complemented with the full range of physico-chemical studies performed in our laboratories.

Solvias AG

  • CH
  • 2015
    On CPhI since

Solvias AG

  • CH
  • 2015
    On CPhI since

More Products from Solvias AG

  • Analytical Services

    Product Analytical Services

    Solvias provides cGMP-compliant contract analytical services to help you ultimately provide safer products to consumers. We provide a comprehensive range of analytical services to the pharmaceutical, biotech, medical devices and cosmetics industry with similar regulatory requirements for raw materials, intermediates, active pharmaceutical ingredients (APIs) and drug products. We pride ourselves on being your reliable and trusted analytical service provider – with the expertise and resources you need to navigate market complexities. With our set of analytical techniques, we offer solutions for analytical questions, such as: Cleaning validation, Extractables & Leachables, Genotoxic impurities, Nitrosamines, Microscopy, Occupational hygiene analytics, Pharmacopeial testing, Release testing, Residual solvents, Stability studies, Trouble shooting
  • Biopharmaceutical Analysis

    Product Biopharmaceutical Analysis

    Solvias has a solid reputation with market-leading biopharmaceutical companies for the characterization and QC analysis of monoclonal antibodies (mAbs), glycoproteins, PEGylated proteins and peptides and biosimilars (follow-on biologics).. This means that businesses of all sizes, even smaller biotechs, can benefit from our knowledge of working with top level companies. Our biopharmaceutical expertise can help you understand the composition of your drug product or substance. Characterization studies, method development, method validation, stability studies, quality control and batch release analysis under FDA Current Good Manufacturing Practice (CGMP) are at the heart of what Solvias offers. Our services are in accordance with the International Conference on Harmonisation (ICH) guidelines of technical requirements for registration of pharmaceuticals for human use. We collaborate with you to plan milestone-based projects that fit your drug development program.
  • Custom Synthesis

    Product Custom Synthesis

    Solvias has all the experience, resources and expertise required to meet your custom synthesis and manufacturing needs.
    Custom synthesis:  lead synthesis up to 20 kg or more / synthesis of scaffolds and building blocks / synthesis/isolation of reference compounds
    Process R&D for: chiral intermediates, APIs or other compounds / development of scalable / robust and cost-effective chemical processes / transfer to our kilogram-scale laboratory
  • Biological Analysis

    Product Biological Analysis

    Solvias provides high calibre microbiology, chemistry, toxicology and cell biology services according to GMP, CGMP (FDA), GLP and ISO 17025 standards.Testing for sterile and non-sterile products / Environmental testing / Specialised studies (antibiotics, integrity testing, alternative methods) / Endoxin and pyrogen testing: monocyte activation test / Cell based bioassays / In vitro assays / Biocompatability / Virus detection and activity measurement
  • Catalysis Technology

    Product Catalysis Technology

    Solvias has a proven track record for the efficient and successful development of catalytic processes. This world-wide recognized expertise spans from discovery (catalyst evaluation) to the production of multi kg batches under optimized reaction conditions.

    Solvias’ areas of technical expertise cover almost any catalytic transformation, which can be implemented in the life science and fine chemicals industry, in particular Homogeneous asymmetric hydrogenation / C-C and C-X cross-coupling / Heterogeneous hydrogenation / Hydrofunctionalization reactions / Enzymatic reactions

    Combining Solvias’ expertise, its powerful High Throughput Experimentation (HTE) platform and a rational design of experiments, a fast and cost efficient investigation and optimization of multiple parameters of catalytic transformations is feasible, thereby accelerating the customer’s development processes to any chiral and non-chiral intermediate or API.
  • Cell and Gene Therapy

    Product Cell and Gene Therapy

    Solvias offers a comprehensive range of orthogonal analytical methods for ATMPs. Our cell and gene therapy building blocks include raw materials testing, cell culture media specific analysis and oligonucleotide analytics. For gene therapies, vector analytics covers the full range of AAV or LV release analytics, including vector aggregation monitoring, sequencing and transfection potency. For cell therapies, our analytical expertise includes cell culture and differentiation mimicking in-life cellular evolutions, process-related impurities testing, recombinant protein expression and functionality determination as well as specific potency assay development. We provide a full complement of release testing to ensure sterility and quality control (QC) for the absence of endotoxins, pyrogens and contamination. We have experience and can support your advanced therapy development from early stage development (e.g. IND application) to commercial testing.

  • Extractables and Leachables Testing

    Product Extractables and Leachables Testing

    Solvias provides expert testing and consulting services for Extractables & Leachables in single-use process materials and container closure systems. With our proprietary EXLEA database, we provide unique automated high throughput screening of more than 6000 Extractablesusing Accurate Mass LC/MS/MS Technology at trace levels. Benefiting from its vast experience in trace analysis using accurate mass LC/MS/MS and GC/MS in complex matrices, Solvias has the capability to provide high quality services for the investigation of E&L in accordance with PQRI, BPOG,EMEA, USP and FDA guidelines.
  • Ligands

    Product Ligands

    Solvias provides wide range of catalysis and ligands which includes ligands. It offers over 700 own ligands and catalysts in its portfolio, all having well-known industrial applications for asymmetric hydrogenation and CX-coupling. Every ligand in portfolio is synthesized through key common intermediates. Visit https://ligands.solvias.com for more information or get in touch.
  • Quality Control and Release Analysis

    Product Quality Control and Release Analysis

    Solvias provides wide range of analytical services which includes quality control and release analysis. The analyses are routinely performed at Solvias according to GMP quality standards for drug substances & products, intermediates, starting materials and excipients. Contact us for more information.
  • Stability Studies

    Product Stability Studies

    Solvias offers the complete range of stability studies according to ICH guidelines for drug development and follow-up stability studies, covering all ICH standard storage conditions as well as low temperature storage. All our processes take place on one connected site, where there is a high degree of QC expertise, scientific dialogue and maximal sample preservation. Our experience and large on-site storage capacity makes us the ideal partner for your stability studies.

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