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Solutions from lab to launch

Peptide Analysis

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

Research
Preclinical
Clinical
Commercial
Characterization & Comparability (including method development)
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Impurities & By-products (including raw material, manufact., degradation)
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Release Testing (including method validation/transfer)
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Stability (including method validation/transfer)
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Reliable Scaling Solutions

As demand for peptide therapeutics rises, scalable and reliable production becomes critical. Collaborating with multiple manufacturers, each with different capabilities and standards, challenges consistency and compliance. Solvias offers a one-stop solution for all analytical needs, ensuring seamless integration with various production facilities. By centralizing processes with Solvias, developers minimize variability, ensure regulatory compliance, and maintain product integrity throughout the production cycle.

5

Expertise

10+ years of experience, 20+ peptide projects​, comprehensive analytical services, scientific & regulatory guidance

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Integration

Seamless collaboration among expert teams and manufacturing facilities, with flexibility to customize packages based on client needs

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Independence

Reliable and scalable solutions, from initial characterization to manufacturer-independent product release testing.

Characterization & Comparability

Deep expertise combined with a broad range of capabilities to effectively assess the physical, chemical, and performance properties of your peptide.

  • AAA (including peptide content)​
  • Sequencing by tandem MS (MS/MS)​
  • Identity by MS​
  • Impurity by MS (cIEF (pI), identity)
  • CD (2nd structure)​
  • DSC, FT-IR​
  • NMR
  • SEC-UV/MALS, SV/SE –AUC ​
  • Light obscuration, MFI, DLS, AF4 ​
  • Intact mass (RP-MS)
  • Bio identity by ELISA/SPR ​
  • Endotoxin testing​
  • Bioburden (e.g. TVC)​
  • Sterility testing
  • Color, appearance, pH, turbidity, melting point​
  • Solubility​
  • Optical rotation​
  • Crystallinity​
  • Polymorphism​
  • Salt screen enabling stable form
  • Quantification/isomer profiling by LC-MS(/MS)​
  • LC-UV-MS, peak purity, (CZE-UV/MS)​
  • Assay, purity, rel. subst., ID, CU by HPLC, counter ion by ion chromatography, titration (water, ion content)​
  • Residue on ignition (sulfated ash)

Impurities & By-Products

Full suite of impurity and contamination control services, covering SPPS & recombinant-based manufacturing, control of raw materials and the final drug product.

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  • Starting materials
  • Peptide-related impurities from manufact.
  • Process-related (non-peptide) impurities
  • Aggregation
  • Degradation products
  • Elemental impurities (ICP-OES, ICP-MS, AAS)​
  • Genotoxic impurities testing, including nitrosamine drug substance related impurities (NDSRIs), polycyclic aromatic hydrocarbons (PAHs), and alkyl halides​
  • Extractables & leachables

  • Fermentation & cell culture components
  • Bacteria/fungi, mycoplasma, viruses
  • Residual DNA & host cell proteins
  • Aggregation
  • Degradation products
  • Elemental impurities (ICP-OES, ICP-MS, AAS)​
  • Genotoxic impurities testing, including nitrosamine drug substance related impurities (NDSRIs), polycyclic aromatic hydrocarbons (PAHs), and alkyl halides​
  • Extractables & leachables

Release Testing

Routine GMP testing with a set of quality- and stability indicating methods validated for this purpose and established compendial tests.

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  • RP-HPLC, LC-MS, NMR​
  • Crystalline solids: XRPD, IR​
  • ELISA/SPR​
  • Endotoxin/bioburden​
  • Potency / efficacy assays​
  • Immunogenicity assays
  • RP-HPLC, LC-MS​
  • Monomer purity (high molecular weight species by SEC-UV)​
  • Counter ion by ion chromatography
  • pH, color, clarity, osmolality​
  • Particulate matter​
  • Subvisible particles​
  • Volume in Injection​
  • CCIT

Stability

With our deep expertise, large storage capacity, and flexible approach we deliver accurate results at every stage of the development cycle.

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  • Intermediate and long-term stability testing​
  • Accelerated stability testing​
  • Forced degradation studies/stress testing​
  • Photostability testing​
  • In-use testing, freeze-thaw cycle testing​
  • Temperature cycle tests​
  • Comparative stability testing​
  • Comprehensive extractables and leachables testing capabilities
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  • API, DS, and DP stability​
  • Excipient compatibility studies​
  • Pre-clinical and clinical formulation stability​
  • Stability of reference standards​
  • Container/closure stability  
  • Final packaging product stability​
  • Long-term stability data​
  • In-use stability testing​
  • Leachables stability testing​
  • Annual product monitoring​
  • Post-approval changes
Don't Take Our Word for it

Our Customers

“The scientific delivery of this quality work from the Solvias team exceeded industry standards. The team are masters of their craft.”
Doug Daniels
Sr. Director of QC, Veloxis Pharmaceuticals
“The drug delivery and physical characterization team provided outstanding support to fine tune analytical methods, perform product specific characterization studies and to complete in vitro BE studies required for product filing at the US FDA.”
Clarissa Gobetti, PhD
CSO, Phargentis
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