End-to-end upstream, downstream, analytical, and formulation development
Get a Free Process EvaluationRobust Process Development (PD) is the critical link in the CMC lifecycle, determining the quality, yield, and commercial viability of your biologic. Creative Biolabs acts as your integrated PD → GMP partner, navigating typical challenges to build a seamless path to manufacturing.
We address key development challenges:
Overcoming expression bottlenecks and complex impurity profiles (HCP, DNA, endotoxin).
Solving aggregation, precipitation, and degradation issues through process and formulation.
Controlling Critical Quality Attributes (e.g., glycosylation) and ensuring the process is robust and scalable.
Building phase-appropriate processes with clear documentation for IND/BLA submissions.
Comprehensive, customizable modules covering every critical stage from cell line to final formulation.
Deep expertise across all major expression systems to ensure optimal host selection for your molecule.
CHO, HEK293
E. coli, Bacillus
Pichia, S. cerevisiae
Sf9, High Five
Our systematic, phase-gated approach ensures robust development and seamless tech transfer to GMP manufacturing.
TPP definition, risk assessment, and initial process strategy.
Host/strain screening, selection, and generation of research cell banks.
DoE-driven optimization of media, feed, and bioreactor parameters.
Development of scalable harvest, chromatography, and TFF steps.
Establishment of phase-appropriate assays for CQA monitoring.
Buffer screening, excipient selection, and accelerated stability studies.
Process verification at pilot scale to ensure robustness and lock parameters.
Comprehensive documentation and support for transfer to GMP suite.
TPP definition, risk assessment, and initial process strategy.
Host/strain screening, selection, and generation of research cell banks.
DoE-driven optimization of media, feed, and bioreactor parameters.
Development of scalable harvest, chromatography, and TFF steps.
Establishment of phase-appropriate assays for CQA monitoring.
Buffer screening, excipient selection, and accelerated stability studies.
Process verification at pilot scale to ensure robustness and lock parameters.
Comprehensive documentation and support for transfer to GMP suite.
| Stage | Services | Key Technologies & Readouts |
|---|---|---|
| Feasibility Assessment | Initial process evaluation, TPP definition, risk assessment, and CMC strategy. | Sequence review, host selection rationale, preliminary CQA definition. |
| Cell Line/Strain Optimization | Host/strain screening, selection, and generation of research cell banks (RCB). | Clone screening (titer, stability), vector optimization, bank characterization. |
| Upstream Process Optimization | DoE-driven optimization of media, feed, and bioreactor parameters (pH, DO, temp). | Scale-down models (e.g., Ambr®), PAT implementation, fed-batch/perfusion. |
| Downstream Purification Dev | Development of scalable harvest, chromatography (Affinity, IEC, HIC), and TFF steps. | Resin screening, impurity clearance studies (HCP, HCDNA), viral inactivation. |
| Analytical Method Development | Establishment of phase-appropriate analytical panel to monitor CQAs. | HPLC/UPLC (SEC, IEX), CE-SDS, icIEF, potency assays (ELISA, cell-based). |
| Formulation & Stability Dev | Screening and selection of a stable formulation (liquid or lyophilized). | High-throughput buffer/excipient screening, accelerated stability, forced degradation. |
| Scale-up & Engineering Runs | Process verification at pilot scale to ensure robustness and define final operating parameters. | Pilot-scale bioreactors (e.g., 50-200L), process parameter locking, material for tox. |
| Tech Transfer to GMP | Comprehensive documentation, process description, and hands-on support for transfer. | Tech transfer package, batch records, on-site support, process validation planning. |
Leveraging state-of-the-art technology to accelerate development and generate high-quality, data-driven processes.
Rapid USP screening and optimization using Ambr® 15 & 250 micro-bioreactors.
Seamless scale-up from 2–10 L bench-scale to 50–200 L pilot-scale single-use systems.
ÄKTA systems (Avant, Pilot) for high-throughput screening and scalable purification.
Optimized Tangential Flow Filtration systems for efficient concentration and diafiltration.
In-line process monitoring using Raman, capacitance, and online metabolite monitors.
In-depth analytical characterization of product quality attributes (e.g., PTMs, identity).
Using JMP & Design-Expert for robust process mapping, optimization, and validation.
Full range of ICH-compliant controlled environments for real-time and accelerated studies.
Our expertise extends from traditional biologics to the most complex and advanced therapeutic modalities.
CHO/HEK stable expression platforms. We focus on controlling glycosylation, charge variants, and aggregation, with specific expertise in BsAb developability and chain pairing.
Host selection (microbial, yeast, mammalian) and strategies for inclusion body refolding. We develop multi-step chromatography workflows and critical enzyme activity/potency assays.
High-yield E. coli fermentation and endotoxin-controlled purification for pDNA. We also optimize IVT synthesis for mRNA, focusing on dsRNA reduction and purity improvement.
Process development for both suspension and adherent upstream production. We specialize in affinity and density-gradient purification to optimize the critical full/empty capsid ratio.
We provide an integrated workflow, starting with the antibody precursor process, optimizing conjugation chemistry (stochastic/site-specific) for DAR tuning, and conducting payload/linker stability studies.
Expertise in notoriously difficult multi-subunit membrane proteins. We optimize expression and employ nanodisc/micelle strategies for solubilization, stabilization, and functional analysis.
Our quality-by-design (QbD) approach is embedded in our DNA. We build processes with regulatory compliance and commercial robustness in mind from day one, ensuring a seamless path to your IND/BLA filing.
Our systems are designed to ensure:
We are more than a service provider; we are your dedicated partner in bringing complex biologics to the clinic and beyond.
A single, integrated partner minimizes tech transfer risk, reduces oversight burden, and accelerates your overall project timelines.
Proven experience with complex modalities including BsAbs, viral vectors, mRNA, and ADCs, ensuring scientific rigor.
Our scientific team is adept at solving the toughest development challenges related to yield, purity, and long-term stability.
We utilize parallel workflows and state-of-the-art high-throughput technology to significantly shorten your path to IND.
A dedicated PhD Project Manager acts as your single point of contact, ensuring clear, consistent, and expert communication.
We have a strong track record of successful engineering runs and executing seamless, well-documented transfers to GMP suites.
Quick answers on PD scope, timelines, scales, and regulatory support.
A typical PD package includes upstream (cell culture, feed strategy), downstream (purification, TFF), analytical method development, and formulation/stability studies. The scope is tailored to your specific needs and regulatory phase.
Timelines vary by modality. A typical mAb process development for an IND-enabling run can take 6-9 months, including cell line development, USP/DSP, and initial stability. Advanced modalities like viral vectors may take longer.
Ideally, we start with a research cell bank (RCB) or plasmid, the sequence or vector map, any existing lab-scale production data, and a Target Product Profile (TPP) outlining your goals for the final product.
Absolutely. We frequently work with clients to troubleshoot, optimize, and scale up existing processes. This can involve gap analysis, DoE-based optimization of specific steps, or adapting a process for our GMP facility.
Our PD labs are equipped from high-throughput micro-bioreactors (Ambr® 15) up to 10L bench-scale bioreactors. We perform engineering and scale-up runs at 50L and 200L, which transfer directly to our GMP manufacturing suites.
Yes. We provide comprehensive development reports and tech transfer packages suitable for inclusion in your IND, BLA, or other regulatory submissions. Our quality system ensures all data is cGMP-compliant and traceable.
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