Biopharmaceutical Analytical Testing

Accelerate your approval process and streamline your drug development journey with Solvias’ biologics analytical services.

From early drug discovery to market launch, we offer end-to-end analytical services for all your biologics. With dedicated project managers and direct access to the subject matter experts, you'll have transparent communication with our specialists, streamlining the timely and successful development and commercialization of your products.

Achieve peace of mind and smooth regulatory submissions with Solvias’ biopharmaceutical analytical testing services. Engage with our experts for personalized solutions today.

Your Partner of Choice for Analytical Development

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Tailored Package for All Stages

Obtain solutions customized to your project stage, from discovery and clinical testing to commercial quality control.

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Optimized Time-Efficient Strategy

Avoid costly setbacks and resource drain by capitalizing on Solvias' 99% on-time, first-time delivery record.

Customized Project Management Approach

Confidently navigate complex biologics analysis assisted by a team of professional customer project managers fully dedicated to your study.

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Robust Regulatory Strategies

Streamline your approval process with Solvias’ analytical services, up-to-date with the latest FDA, IHC, and ISO 9001 regulations for full compliance.

Solvias Brings Deep Expertise in the Fastest Growing Areas of Biopharmaceutical Innovation

Full-Service CMC Provider

GMP service provider for all CMC related needs including strong project management and direct access to our experts.

Biologics to Advanced Therapy Medicinal Products (ATMP)

Years of experience in the biologics space were quickly adapted to provide expert support for ATMPs.

High Growth Modalities

Specific know-how for high growth modalities including cell and gene therapy, antibody-drug conjugates, mRNA, lipid nanoparticles and vaccines.

Unique Mix of Biological & Physical Chemistry Testing

Along with a full suite of analytical methods for both biologics and small molecules, we can offer particle characterization, extractables and leachables and excipient testing.

Comprehensive Biologics Analytical Services

Characterization, comparability studies, method development and validation, release testing, and stability testing are closely related and interdependent activities that collectively ensure the quality, safety, and efficacy of the final product.

Characterization is the cornerstone of an effective CMC program. Ensuring robust characterization of your biologic will reduce the risk of finding unexpected issues and enable seamless comparability testing. Our expert scientists can help distinguish between normal variability and changes that can affect efficacy and safety.

Our experience allows us to anticipate and understand. No literature exists that will tell you what to do with a new molecule, you need to rely on your experience.

We can look at quality attributes and do a risk assessment to see what impacts these characteristics might have on stability, potency, purity, and safety. You need to know how a molecule will behave in different situations. Good structural analysis will streamline downstream steps.

We offer a broad toolkit of analytical platform methods, making the process faster and reducing the time and expense of extensive optimization. You will also receive complete method protocols. Our method selection and development are based on PQTTP and QBD principles with phase appropriate validations, strategy and execution.

We can quickly identify the right method and compile a customized package with our array of tools. Investing in increased robustness and efficiency in your testing will lower the costs of your release testing panel. Solvias follows ICH Q2A & Q2B guidance for analytical standards and method development.

Release testing is required for all clinical and commercial batches. Well established CQAs and validated methods are important for both drug substance and drug product release testing.

Characterization data and CQAs guide the selection of stability tests to ensure quality and efficacy over time. Jumpstart your stability studies and take advantage of our capacity. We offer a comprehensive storage and testing portfolio with experience in real-time and accelerated studies.

Complete Bioanalytical Portfolio

Complete in-house offering to ensure full service from comprehensive characterization to commercial GMP testing

Identity

  • N-terminal Sequencing
  • Peptide Mapping
  • Intact Mass ESI-MS
  • cIEF
  • Bioassay

Conformation

  • CD
  • FTIR
  • Fluorescence
  • DSC
  • NMR
  • HDX –MS (hydrogen deuterium exchange mass spectrometry

Sequence

  • N- & C-terminal Sequencing
  • Amino Acid Analysis
  • Mass Spectrometry
  • Peptide Mapping
  • Glycan Analysis

Potency

  • Binding assay
  • Classical cell-based bioassay
  • Cell-based bioassay with LC-MS readout
  • Enzyme activity assay
  • Surface Plasmon Resonance

Modifications

  • Glycosylation
  • Deamidation
  • Oxidation
  • Misincorporation
  • Truncation N- & C-Terminal

Impurities

  • DNA
  • qPCR
  • HCP
  • ELISA
  • Western Blot
  • Mass Spectrometry
  • ICP-MS
  • E&L

Purity

  • RP-HPLC
  • HIC
  • SEC
  • SDS-PAGE
  • CGE(-SDS)
  • ELISA
  • Western Blot

Heterogeneity

  • N- & O-Glycosylation
  • Charged variants
  • IEX
  • cIEF
  • CZE

Aggregates

  • AUC
  • SEC
  • MALS
  • DLS
  • AF4

Concentration

  • UV absorption
  • ELISA
  • Protein Assay
  • AAA content

Particles

  • Visual
  • Turbidity
  • Light Obscuration
  • MFI

General

  • Appearance
  • pH
  • Particulate matter
  • Sterility
  • Endotoxins
  • Container Closure
  • Reconstitution

Ready to Streamline Your Biopharmaceutical Analytical Testing?

Accelerate your timeline with our targeted analytical testing packages, designed for a seamless and stress-free experience.

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