From lab to global scale: building OSD success together

Key takeaways
              Syntegon supports pharmaceutical manufacturers throughout the entire OSD lifecycle – from formulation development to production scale to process optimization.
Consistent technologies and transferable process concepts enable efficient scale-up across batch sizes.
Deep process expertise helps manufacturers accelerate development, validation, and commercial transfer.

            

Faster development timelines and increasing efficiency demands are putting growing pressure on OSD manufacturers. They need to generate reliable data for clinical studies, validate processes, and ensure that development results can be transferred to commercial manufacturing. At the same time, existing processes must be continuously optimized to remain competitive and comply with regulatory requirements.

As a strategic partner to the pharmaceutical and biotech industry, Syntegon supports manufacturers with technologies that follow consistent process principles across different scales and batch sizes, and process expertise that guides manufacturers every step of the way. This support begins long before equipment is installed. Manufacturers can either develop, validate, and scale their processes together with Syntegon in its global OSD Customer Centers or apply the same technologies and processes in their own production environment. In both cases, they benefit from consistent process principles and seamless technology transfer throughout the entire OSD lifecycle. This approach creates the foundation for reliable development, efficient scale-up, and process optimization, with dedicated technologies supporting every phase from R&D to commercial production.

R&D and formulation development: building the foundation

Successful OSD products require a deep understanding of formulations and process behavior. During R&D, manufacturers need to evaluate formulations in the lab, identify critical process parameters, and generate reliable data while minimizing the use of valuable APIs. Decisions made during formulation development can determine the success of later scale-ups. Therefore, establishing robust process parameters early on creates the foundation for efficient validation, reliable transfer, and future scale-up.

Equipment for R&D and formulation development

Mycromix

The high-shear mixer granulates very small batch sizes, helping manufacturers evaluate formulations while conserving valuable materials.

GKF 60

Designed for early R&D, the capsule filler supports formulation studies with a wide range of dosing technologies and small batch sizes, helping manufacturers accelerate development, conserve valuable APIs while generating reliable development data for seamless scale-up.

SolidLab 1

The compact granulation platform helps manufacturers evaluate formulation feasibility and understand powder behavior, providing the foundation for robust process development.

Pilot scale: proving transferability

Once a promising formulation and process have been established, manufacturers need to prove that development results can be reproduced at larger scales. Pilot operations play a critical role in generating clinical trial material and validating process parameters. At this stage, focus shifts from development to transferability: Manufacturers need proof that a process will behave predictably as batch sizes increase and production requirements become more demanding. Generating reliable scale-up data and validating processes under the right conditions creates the basis for a smooth transfer to large-scale manufacturing.

Equipment for pilot operations

Pilotmix

As the link between laboratory and production scale, the high-shear mixer enables manufacturers to evaluate larger batches while generating reliable data to minimize risk during scale-up and transfer.

Pilotlab

The pilot-scale platform enables manufacturers to validate process performance under representative conditions, generate reliable scale-up data, and reduce transfer risks before commercial manufacturing.

Small-batch manufacturing: bridging development and production

Before moving to full commercial scale, many manufacturers need to produce clinical or small commercial batches. Unlike with pilots, the focus is not on proving transferability, but on manufacturing a product under real production conditions. Small-batch manufacturing aims at gaining operational experience, supplying clinical studies, and refining production strategies while minimizing risk and investment, while also providing an opportunity to evaluate and optimize manufacturing processes under real production conditions before commercial scale-up.

Scale-up and transfer: translating process knowledge into production

Scale-up is where development work is put to the test. Processes that have been validated in pilot and small-batch operations must be transferred efficiently to larger production volumes while maintaining consistent product quality, recipe and process parameters. Any deviation can lead to delays, additional validation efforts, or expensive adjustments. This requires technologies that follow the same process principles across scales, combined with the expertise to move into commercial production with lower risk.

“The same process knowledge that accelerates product development can also reduce risk during transfer and unlock optimization opportunities years later in commercial production.”

Christian Paasche, Technical Product Manager at Syntegon

Equipment for scale-up and transfer

SolidLab 2 Plus

The modular platform enables process development and validation using the same process principles applied at larger scales, allowing for reliable tech transfer.

SolidLab X

Designed for efficient scale-up, SolidLab X helps manufacturers transfer proven processes to larger production volumes while maintaining consistent product quality.

Production: driving continuous improvement

Reaching commercial production is not the end of the journey. As market demands and regulatory requirements evolve, manufacturers are continuously challenged to adapt to new products, improve efficiency, increase yield, and maintain product quality. Many improvements can be evaluated at small scale, allowing manufacturers to test changes and validate optimization measures with lower material costs and less risk than full-scale production trials.

Services for process optimization

As a strategic partner throughout the OSD lifecycle, Syntegon builds on the process knowledge gained from early development through commercial scale-up to help manufacturers optimize production performance, improve efficiency, and adapt existing processes to evolving products, regulatory requirements, and market demands.

Visit Syntegon at CPHI to discover how manufacturers can benefit from a seamless R&D approach that combines process expertise and technologies under one partner, creating a reliable path from early development to commercial manufacturing – or contact our experts to explore the right approach for your application.

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From lab to global scale: building OSD success together

Key takeaways

R&D and formulation development: building the foundation

Equipment for R&D and formulation development

Mycromix

GKF 60

SolidLab 1

Pilot scale: proving transferability

Equipment for pilot operations

Pilotmix

Pilotlab

Small-batch manufacturing: bridging development and production

Scale-up and transfer: translating process knowledge into production

Equipment for scale-up and transfer

SolidLab 2 Plus

SolidLab X

Production: driving continuous improvement

Services for process optimization

Interested in our pharma solutions?

Discover more about Syntegon

From lab to global scale: building OSD success together

Key takeaways

R&D and formulation development: building the foundation

Equipment for R&D and formulation development

Mycromix

GKF 60

SolidLab 1

Pilot scale: proving transferability

Equipment for pilot operations

Pilotmix

Pilotlab

Small-batch manufacturing: bridging development and production

Scale-up and transfer: translating process knowledge into production

Equipment for scale-up and transfer

SolidLab 2 Plus

SolidLab X

Production: driving continuous improvement

Services for process optimization

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Interested in our pharma solutions?

Discover more about Syntegon