An integrated solution utilizes engineering expertise to combine multiple unit operations into a single, centrally automated process, supported by comprehensive technical services. This philosophy can be applied to two or more unit operations or be expanded to provide a complete end to end solution.
Benefits of Integrated Solutions
Moving to integrated solutions will help simplify and streamline your manufacturing process, speeding time to market and reducing overall cost of goods. The simplified process, using standard, equipment, qualified single-use system designs and components, lowers the risk for operator error, which helps assure compliance with cGMP and assure product quality.
Pall Biotech Integrated Solutions
Our integrated solutions team combines best engineering and project management practices with an in depth industry knowledge and diverse equipment portfolio to deliver these benefits on time and on budget, ready for when you need them.
Whether you are producing mAbs, recombinant proteins, vaccines, cell or gene therapies, Pall Biotech can provide fully integrated bioprocessing solutions from discovery through to commercialization; from upstream through to final filling; from initial design through to implementation.
With a range of solutions covering traditional stainless steel and single-use, working in batch, fed-batch or continuous processing mode – and with hybrid solutions combining these technologies, our extensive product portfolio means we can offer you the complete solution you need.
Engineering and Scientific Expertise
Having the correct product offering is only part of the story – it is essential to partner with a provider who also has the engineering and scientific expertise and experience to deliver the optimal solution to meet your requirements.
We work with you to develop your system solution to meet your process requirements. Optimal system design is achieved based on our class leading know-how, considering physical and operational constraint mapping, whilst always keeping usability in mind. And with 4 biotech engineering centers of excellence, based in China, India, Germany and USA, the expert support you need is never too far away.
With a dedicated team of over 200 engineers based in 13 countries, speaking over 25 languages, many of our engineers have come to Pall from biotech and biopharmaceutical companies, working on mAbs, gene therapies and other processes, so have a broad depth of experience from working in the industry.
Our team of over 270 scientists based in 6 hubs around the world, provide integrated global technical support, from process development, validation and qualification, through to operator training, which enables you to rapidly transition from preclinical through to commercialization.
We can help you develop automation & control strategies including data integrity tests, PAT, data analysis and real-time release & digital batch records, ensuring you the benefit of robust security of supply for all process consumables, helping you meet stringent regulatory requirements.
Solutions for All Process Requirements
Pall Biotech’s product portfolio is extensive and complete, allowing us to deliver integrated solutions for all the unit operations steps from upstream through downstream, to final formulation and filling, using batch, fed-batch or continuous processing. This ensures continuity and compatibility of materials and equipment, simplifying validation and qualification processes.
In today’s market, manufacturers need to be able to quickly respond to changes in demand. Our range of single-use and hybrid solutions increases facility flexibility, to enable easy and fast modification of set-ups for different processes or to cope with increased capacity demands.
Working with You
Discuss and Define
No two biotech manufacturing requirements are the same, so it is essential that we fully understand YOUR process and YOUR requirements, before we propose any solutions. Our process engineering know how is best in class, we always approach each project by understanding YOUR process requirements down to a fundamental mass balance level and then tailor the best solution.
Develop and Design
Based on your requirements and our expertise, we will design the equipment and consumables for your fully integrated solution, assuring connectivity between process steps, offering automation and control strategies, and ensuring regulatory compliance. Our 3D facility modelling software ensures we design a solution ensures your final design is optimized for efficiency, usability and flexibility.
We will ensure your integrated solution is delivered within specifications, on time and within budget. Our expert team of engineers and scientists will test (FAT/SAT/IV/OV) and help you validate (IQ/OQ/PQ) your integrated solution, and train operators to ensure you are fully cGMP compliant and operational as quickly as possible.
Once your new process is up and running, we will continue to support you with ongoing training as required, regular servicing of equipment, and assurance of supply for all your process consumables.
We have many years’ experience in delivering integrated solutions to customers throughout the world, across the entire manufacturing process.
Based in the USA, our customer wanted a complete single-use solution for gene-therapy viral vector contract manufacturing, which could be implemented in two existing facilities in the shortest possible time.
The upstream solution included seed bioreactors, feeding into single-use stirred-tank bioreactors up to 1000 L for clinical manufacturing, and up to 2000 L for commercial manufacturing, with fixed-bed bioreactors for scale-up of adherent processes, and a variety of single-use mixers for media and buffer prep. The downstream purification solution included single-use tangential flow filtration systems, fluid automation systems, mixers, and single-use chromatography systems.
Our team delivered a cost effective end to end solution, within the required extremely tight time lines.
A customer in Asia wanted a flexible bio manufacturing facility for their 2000 L capacity manufacturing of the multiple monoclonal antibodies.
Upstream single-use solution from 25 L seed bioreactor scaling up to multiple 2000 L single-use stirred tank bioreactors. With a hybrid downstream solution covering media and buffer preparation, chromatography and virus filtration, supported by Pall validation services.
We streamlined their process, simplifying material management and validation, and optimizing overall process efficiencies.
A European based contract manufacturer wanted a complete mAb downstream processing solution for their 1000 L process, which combined the latest trends of both single-use and continuous technologies.
We designed an integrated continuous solution for their complete DSP processes which incorporated depth filtration, multicolumn continuous chromatography system with virus inactivation and associated storage.
Our expertise with the new technologies and our assistance with onsite trials helped expedite the implementation of their new process. We also standardized the single-use systems on site to reduce inventory and simplify operator training.