Biologic Drug Analytics

Biopharmaceutical Process Development Services

ProtaGene provides biopharmaceutical process development services with phase-appropriate qualification and validation strategies across product and process development. We support teams in understanding product quality, assessing change impact, and progressing biologics process development and biologics drug product development. In practice, development spans the upstream process and downstream process development and expands as programs move from early drug development into clinical and commercial stages. We align studies and documentation to your phase and project requirements.

Biopharmaceutical Process Development: What We Support

We support biopharmaceutical process development with analytical development and phase-appropriate qualification and validation strategies. Our process development services help connect process parameters to product quality across the manufacturing process—from upstream process development through downstream process development, including work on drug substance and drug products.

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Technology Transfer

During technology transfer, the key challenge is keeping data comparable as the manufacturing process changes in scale, equipment, or site. ProtaGene supports technology transfer with analytical development strategies that maintain continuity and reduce uncertainty—so that process parameters, product quality, and comparability data remain reliable as programs move toward later clinical and commercial stages.

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    Analytical continuity planning across phases and sites
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    Comparability strategies to support tech transfer decisions
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    Support for identifying process parameters to monitor during scale up activities
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    Documentation support aligned with internal governance and quality expectations
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    Phase-appropriate, cost effective analytical plans to support development timelines
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Upstream & Downstream Process Development

Process development is rarely one decision – it’s a chain of process steps where upstream and downstream choices influence each other. Analytical support helps you interpret whether shifts in process parameters are driving meaningful changes in product quality, or whether differences are within expected variability. This is especially useful during developing and optimizing cycles, when teams need data that stays interpretable across multiple steps of the manufacturing process.

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    Phase-appropriate analytics supporting upstream process development and downstream process development
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    Analytical readouts to track trends and variability across process steps
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    Impurity and residual assessment support where applicable
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    Data packages to support development decisions for drug substance and intermediate materials
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    Fit-for-purpose study planning designed to be practical and cost effective
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Biologics Drug Product Development: Formulation & Stability

Formulation and product understanding dictate drug product stability, which is essential for product efficacy and patient safety. Analysis of the stability, especially under accelerated and stress storage conditions, across different formulations by high resolution methods supports the selection of the correct formulation. In addition, ProtaGene supports the execution of long-term stability studies, stress studies, and forced degradation studies to build comprehensive stability profiles across development and manufacturing stages.

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    (Pre-)formulation support for formulation screening and selection
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    Analytics for stability studies and stress studies under accelerated and stress storage conditions
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    Forced degradation studies to explore degradation pathways and risk drivers
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    High resolution methods to support formulation decisions and change assessment
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    Data to support drug product process development decisions across phases
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Process Characterization & Comparability

Process characterization focuses on learning what truly drives outcomes in your process not just what changed. Linking clinical results from process A to the properties of process B is the key to meaningful comparability. ProtaGene supports comparability programs with release panel testing, extended characterization, and stability studies, connecting process parameters and process steps to product quality across the manufacturing process during biopharmaceutical process development.

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    Process characterization studies supported by analytical testing across process steps
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    Comparability testing with release panel, extended characterization, and stability studies
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    Support for interpreting differences and trends in drug substance and drug products
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    Impurity/residual assessment support (including clearance-related questions where applicable)
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    Documentation and data packages aligned with project and regulatory needs

Analytical Solutions from Research to Market

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Research
Preclinical
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Discovery – Pre-clinical

Biologic Candidate Evaluation, Optimization and Selection into IND

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Phase I
Phase II
Phase III
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Phase I – Phase III

Release, Clinical Data and Characterization Packages for Accelerating Phase I-III Programs through BLA

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Registration
Market
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Registration – Market

Commercial-Stage Comparability Testing by Qualified Advanced Methods

Why ProtaGene for Biopharmaceutical Process Development

ProtaGene supports upstream, downstream, and drug product process development with high resolution methods to generate interpretable data across the manufacturing process. Whether you need to assess change impact, track process parameters, or build comparability packages, our process development services help you make well-supported decisions from early drug development through clinical and commercial programs. What you can expect partnering with ProtaGene:
  • Clear deliverables and well-defined outputs aligned to your development stage and intended use
  • Phase-appropriate study packages that help connect process parameters to product quality across drug substance and drug products
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Biologic Therapeutics Platform Expertise

Our deep experience advancing a diverse range of therapeutic platforms from research through market help the ProtaGene team design highly effective analytical programs that de-risk development and accelerate timelines to your next key milestones. Key biologic development areas include:

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    Recombinant proteins—including complex, highly glycosylated proteins

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    Multi-subunit complexes—protein, nucleotide, ligand

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    mAbs

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    ADCs and protein conjugates

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    PEGylated proteins

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    Bispecifics/multispecifics

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    Fusion proteins

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    Enzyme replacement therapies

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    Biosimilars

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    Vaccines, including subunit/recombinant

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Analytical Systems

Enabled by state-of-the-art technology, ProtaGene offers an extensive range of analytical capabilities to support your biotherapeutic or gene & cell therapy projects.

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Talk to Our Process Development Experts

If you are planning biopharmaceutical process development, biologics process development, or biologics drug product development, we can discuss the analytical development and process characterization support that fits your phase, timelines, and manufacturing process needs. Our process development services focus on generating clear, actionable data that supports development and manufacturing decisions across clinical and commercial programs.

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