Process Development

To effect critical time to market, companies will need to consider their cell line & process development strategies early in the drug development cycle, taking the investment risk of increasing their own capacity and resource base or alternatively limiting that risk by outsourcing.

Process development is a critical aspect of biologics manufacturing, as it enables the creation of a viable drug candidate with the greatest potential for scalability and commercial manufacture. Biologics process development is an active undertaking that seeks continuous improvement along the entire length of the drug development timeline. It involves the design and optimization of a method to create a drug candidate from a biomolecule, requiring skill and experience, and is guided by expertise. Rodon uses their extensive experience in process development and optimisation to deliver a robust, scalable high yielding manufacturing process for your molecules. company such as Rodon Biologics, with more than 20 years of experience, can help understand the nuances and tactics involved in process development.

Rodon’s process development services are performed as a stand-alone or integrated with cell line development programs.

Our team holds significant expertise in both upstream and downstream process development, guaranteeing robust, scalable, and high-yield processes tailored to meet the specific needs of each project, from early-stage development to commercial manufacturing.

Our process development services include:

Upstream Process Development At Rodon Biologics, our upstream process development services are designed to optimize cell culture conditions for maximum productivity, scalability, and reproducibility. We leverage our expertise in mammalian and microbial expression systems to develop robust bioprocesses that ensure high-yield production of biologics.

Our team specializes in:

✓ Media & Feed Optimization – Enhancing cell growth and productivity through different media formulations (animal component free)
✓ Bioreactor Process Development – Establishing scalable and high-performing processes in shake flasks and benchtop bioreactors.
✓ Process Characterization & Optimization – Fine-tuning critical parameters to improve yield, quality, and consistency.
✓ Tech Transfer & Scale-Up – Seamless transition from lab-scale to manufacturing while ensuring process robustness.

Whether integrated with cell line development or as a stand-alone service, our upstream process development solutions support the efficient production of monoclonal antibodies, recombinant proteins, and other biologics.

Downstream Process development Rodon Biologics offers downstream process development services to ensure efficient purification, high product recovery, and consistent quality of biologics. Our team specializes in designing and optimizing purification strategies tailored to each molecule’s unique properties, delivering scalable and cost-effective solutions.

Our expertise includes:

✓ Harvest & Clarification – Optimizing cell removal techniques, including centrifugation and filtration, to maximize product yield.
✓ Chromatography Development – Designing purification workflows using affinity, ion exchange, and other advanced chromatography techniques.
✓ Ultrafiltration & Diafiltration – Developing robust filtration strategies for buffer exchange and product concentration.
✓ Process Characterization & Optimization – Ensuring high purity, stability, and reproducibility through extensive process analytics.
✓ Tech Transfer & Scale-Up – Supporting seamless transition to GMP manufacturing with scalable purification strategies.

Analytical Support At Rodon Biologics, we recognize that robust analytical support is essential for ensuring product quality, process consistency, and regulatory compliance. Our Analytical Support & Development services are designed to provide comprehensive characterization, in-process monitoring, and final product testing for biologics.

Our capabilities include:

✓ Method Development & Validation – Custom development and optimization of analytical methods tailored to your molecule’s properties and regulatory requirements.
✓ In-Process & Product Characterization – Real-time monitoring of critical quality attributes (CQAs) to ensure process consistency and product integrity.
✓ Protein Analysis – Comprehensive testing, including HPLC, ELISA, SDS-PAGE, Western Blot, and more.
✓ Purity & Impurity Profiling – Detection and quantification of host cell proteins, aggregates, and other impurities.
✓ Stability Studies – Forced degradation and long-term stability assessments to determine product shelf life and formulation robustness.
✓ Tech Transfer & GMP Readiness – Seamless method transfer to GMP environments, supporting regulatory filings.

Our analytical team works in close collaboration with process development teams to provide data-driven insights that accelerate process optimization and ensure high-quality, regulatory-compliant biologics.

Formulation Development At Rodon Biologics, we understand that a well-designed formulation is critical for ensuring the stability, efficacy, and manufacturability of biologics. Our Formulation Development services focus on optimizing product stability, extending shelf life, and enhancing overall product performance.

Our Expertise includes:

✓ Preformulation Studies – Assessment of physicochemical properties, solubility, and stability to guide formulation strategies.
✓ Buffer & Excipient Selection – Identification of optimal conditions to maintain product integrity and prevent degradation.
✓ Stability Optimization – Forced degradation studies to evaluate the impact of stress factors such as temperature, pH, and agitation.
✓ Liquid Formulation Development – Tailored approaches to meet product-specific requirements for long-term stability.
✓ High-Concentration Protein Formulations – Development of formulations suitable for subcutaneous or intravenous administration.
✓ Compatibility & Container Closure Testing – Ensuring product stability in vials, prefilled syringes, and other delivery systems.

Scale-up and Transfer for Manufacturing At Rodon Biologics, the scale-up and transfer process is a pivotal phase in biologics development, ensuring that laboratory-scale processes are effectively translated into large-scale manufacturing. This involves meticulous planning and execution to maintain product quality and consistency throughout the transition. Our team leverages extensive experience in scaling up processes, optimizing process parameters, and implementing robust quality control measures.

By employing a phase-appropriate approach, we ensure that each step is tailored to the specific needs of the drug candidate, from bench scale to commercial production. This seamless transfer is supported by comprehensive documentation and collaboration with GMP manufacturing sites, ultimately accelerating the path to market while minimizing risk and ensuring the final product meets the highest standards of efficacy and stability.

Collaborative and Transparent Biologics Process Development

We prioritize open communication and regular information exchange with our clients as projects advance. Our meticulous record-keeping ensures effective management, progress evaluation, and seamless process transfer. Partner with us to develop high-purity, scalable, and cost-efficient processes for your biologics pipeline. Our experts work collaboratively with clients to create tailored solutions, ensuring high-quality outcomes through every phase of product development.