In general, Process Development (PD) service involves downstream purification processes towards feasibility, optimization and scale up studies. At NNSPL, we can screen among technologies to select an appropriate one that will efficiently produce your desired product quality. We also provide contractual manufacturing of desired product. Our services play an important role in ensuring a desired product is adapted to a strong platform that is scalable and creates a blueprint that delivers optimal yields and productivity. Investing time and money in Our services ensures rapid development of your manufacturing process that will accelerate your desired product to the market.
Our Process Development Service covers:
- Selection of suitable membranes to meet the objective
- Screening of resins used in low pressure liquid chromatography (LPLC)
- Screening of stationary phase used in high pressure liquid chromatography (HPLC)
- Batch, semi-continuous batch process development
- Process optimization and reproducibility studies
- Scale-up studies and data generation
We have extensive experience and capability to design, develop, optimize and troubleshoot for all stages of process development with a variety of approaches.
Equipment & Capabilities:
- Hipersep HPLC Pumping Skid Novasep
- Hipersep Lab HPLC 50 mm dia Column – Novasep
- Hipersep Lab HPLC 110 mm dia Column – Novasep
- HPLC System (4.6 mm dia column)- Thermo
- Lab scale low pressure liquid chromatography column – LPLC
- Pilot scale LPLC column
- Stirred Cell – NNSPL
- Lab and Pilot scale membrane unit – NNSPL
- Spray Dryer – Techno Source
- Handheld Refractometer – Alla France
- Diaphragm type compressor and
- pH & conductivity meter
- Vortex mixer and heating mantle
- Magnetic stirrer with heater Boiling water bath
- Hot air oven
- Deep freezer and refrigerator
- Ultrasound bath – PCI
- UV 1800 Spectrophotometer – Shimadzu
- Rotary Vacuum Evaporator – Equitron
- Micro Centrifuge – Remi
Applications/Projects served in Process Development:
- Biomass Separation
- Components Catered
- Plant Proteins
- Fine Chemicals
- Soy Proteins
Why Do I Need Process Development Services?
Industrializing a desired product is a complex and challenging journey, which becomes more difficult when the constraints of equipment scalability are not considered early on in process development.
Emerging desired products are typically born at academic or start-up company level and there may not be a clear roadmap to scalable and reproducible manufacturing processes. Such a gap introduces the risks of batch failure or issues in scaling up to commercial production in the accelerated approval timeframe associated with these emerging therapeutics.
Recent advances in technology mean that operating a continuous manufacturing process with a smaller footprint is now also a desirable option that should be considered at Process Development stage. However, producing multiple biologic and biosimilar products in a single facility using continuous processing can be a challenge. The correct Process Development partner will help you evaluate batch versus continuous processing and will work with you to determine the right option for you and your product.
How Will Process Development Services Help You?
Investing time and effort in your process development will alleviate pain points when it comes to scaling your project to commercial manufacturing.
PD services can help you develop a platform that saves you both time and money since you will not be required to ‘re-create’ the wheel for each scale up. Working with your chosen PD services partner will help you to adopt a platform that can deliver a complete, customized process which can improve process reliability and decrease facility footprint.
What Problems Can Process Development Solve?
A PD service provider will address multiple challenges that you may be facing. This includes entire process industrialization, limited pool of resources and technical expertise, and platform complications. These problems are particularly prominent in emerging API, Biopharma, Nutraceutical manufacturing as well as in emerging technologies such as automated continuous bioprocessing.
What will a Process Development Partner Do for You?
A PD service provider can either simplify your current process or work with you to re-develop it from the ground up. They will then work with you to translate the process into a fully integrated and scalable platform paving the path to industrialization.
Your PD provider will help you in selecting an ideal platform, process characterization and consistency runs. They will work with you to develop comprehensive manufacturing protocols. Your PD provider will also optimize your process for downstream process and scale-up, helping you achieves process performance and commercial viability
What Should I Expect from a Process Development Partner?
You should expect the provider to place a strong emphasis on open and collaborative dialogue. The team should first listen to your needs and ideas and then align on your research objectives. To ensure success, you can expect support/lab trials, training, and documentation from their experts to either your team or designated CMO.
Partnering with a process development provider that has a strong track record of technical expertise, developing a multistage process, as well as delivering on time; will help you to navigate some of the complexities associated with bringing a desired product to market.
The commercial application of technology developed in the laboratory to industrial application requires the scaling up from the bench scale (0.1 to 1L) to the industrial scale (10,000 – 1,000,000+ L), representing an increase of 10,000 to 1,000,000+ X, presenting a number of scale-up, process, equipment design, and technology risks. The incremental scale up of process technologies to the pilot scale demonstrates the scalability of the technology and reduces the risks & costs associated with commercialization.
|Advantages of Technology Piloting:|
|Validation of Lab Scale Results,|
|Demonstration of Process Scalability,|
|Scaling Solutions (sterility, heat transfer),|
|Effects of Technology Process Integration,|
|Commercialization Risk Reduction|