Process Development
Providing state-of-the-art technology in process development
At NAYA LS, we provide Process Development Services for the (bio)pharmaceutical industries, that can either improve your current process or (re)develop it from the ground up. Our experts in Process and Analytical Method Development can work with you to translate the process into a fully integrated and scalable platform paving the path to industrialisation.
As PD provider, we help you in selecting an ideal platform, process specification and production consistency, and in developing comprehensive manufacturing protocols. We can also optimise and scale up/down your production process, helping you achieve process performance, commercial viability, and compliance with regulatory and quality requirements (for both process as well as manufacturing scales).
Using the latest processing platforms and technologies, we provide our clients with distinct tailor-made packages, such as early-stage process development for start-ups, and scale-up/down, process optimisation and troubleshooting for industrial manufacturers.
Our Process Development Services
Formulation Development
We use our knowledge in research and in the (bio)pharma industry to support our clients in product development, optimisation and formulation development.
During the process of formulation development for peptide, (bio)pharmaceutical and vaccine products, we address all process-related aspects like stability, safety, route of delivery or dosage form to help our clients accelerate their drug development program.
We also invest our knowledge in the development of innovative platforms of pharmaceutical products to enable commercialisation of efficient formulations based on controlled and targeted drug release, thus overcoming certain drawbacks of conventional formulations.
Our formulation team is involved in the development of Liposomes, Microsphere, Polymeric nanoparticles, Lipid Nano Particle (LNP) and 3D printed solid dosage forms.
Upstream Process Development
We provide a series of upstream process development solutions, to create a robust, high-yielding upstream process through a combination of powerful technologies, high-quality starting material and a brilliant process design.
We offer a comprehensive suite of upstream process development services, either for early-stage cloning or media development, detailed process optimisation or a robust commercial production process.
- Bioreactor/fermenter Design (H:D, impeller type, sparger type)
- Media Development
- Batch and continuous (perfusion) bioreactor condition development
- Feeding strategy (type of feed, concentration and feed addition Schedule)
- Operational Parameter Optimisation (T, pH, DO, Agitation, Pressure)Protein folding and refolding
- Upstream process scale-up/scale-down
- Harvesting studies
- Cell removal strategy
Filling and Packaging development
To meet the challenges of aseptic filling of (bio)pharmaceutical products, we embrace a holistic approach to engineering comprehensive filling and packaging solutions for various fields such as cell or gene therapies, small molecules, biologics or other ingredients in the rapidly growing field of advanced therapy medicinal products. We offer a range of primary packaging solutions for aseptic filling of vials, syringes, bottles and cartridges, as well as Dual Chamber Systems (DCS).
Our solutions prevent costly overfilling or spilling of products and they are tailor-made to accommodate specific customer needs.
- Facility design and equipment in line with all applicable guidelines
- Selection and development of proper final product dose
- Selection and development of primary packaging material
- Selection and development of secondary packaging material
- Selection and development of filling concept (presterilised or not)
- Performance of validation media fill batches
- Development of a proper environmental monitoring system for filling and
supporting area - Development of a freeze-drying process
- Development of terminal sterilisation for unsterile products
- Development of a proper filtration step for aseptic products
- Development of a proper process for suspended products
Analytical Method Development and Validation
Relying on our extensive experience in product and method development, we help our clients to quickly achieve their analytical method development goals.
Our Quality Team can support you in developing your product specification and analytical methods for your drug substance, drug, or in-process products, to assure the quality aspect as per ICH/FDA/EMA guidelines, EP, BP, and USP.
Our expert services enable our clients to ensure rapid transition from product development to product release.
- Assays (HPLC)
- Bio-Assays (viral and non-viral)
- Impurities (HPLC)
- Pharmaceutical Microbiology
- Endotoxin by gel clot
- Bioburden and Bacteriostasis/sterility testing
- Total Organic Carbon (TOC)
- ELISA testing
We also provide analytical support services to ensure a smooth transfer of information to third-party laboratories or contract manufacturing partners.
Downstream Process Development
Whether you need a completely new downstream process development or DSP adaption and optimization, we ensure efficient downstream process development to meet the requirements of product purity.
Our platform processes are designed to maximise purity and yield, while minimising time consumption between development and implementation. They are tailor-made to meet our clients’ specifications.
- Harvesting and filtration
- Primary capture
- Buffer exchange and up-concentration
- Purification
- Bioconjugation
- Virus inactivation and clearance
- Formulation
- Process reproducibility studies
- Scale-up and down calculation
