Gerteis Mini-Pactor® provides Nucleo with fast-to-market solutions

Jona, Switzerland: – Dry granulation expert Gerteis has supplied a roller compaction solution (Mini-Pactor) to Nucleo Life Sciences which established a successful fast-to-market boutique drug development service.

Nucleo Life Sciences is a modern and state-of-the-art contract development & research lab (CRO) based in San Rafael, CA covering all phases of small molecule drug product development.

Key technology

Pharmaceutical roller compaction is an efficient dry granulation process used to increase the particle size of poorly flowing powders by compacting them into a ribbon or compact. This compacted material is then milled to increase the particle size and producing a blend that is free flowing and suitable for tablet compression, capsule filling, or filling into sachets. Gerteis is the Swiss manufacturer of advanced high-quality roller compactor and has set the global standard with their unique design of dry granulation technology.

Nucleo has embraced roller compaction as an increasingly important agglomeration technology for the production of granules, as the pharmaceutical industry looks at ways in which it can introduce lean manufacturing to reduce its R&D and manufacturing costs by QbD.

Scale-up advantage

The company’s founders have a long history of using the Gerteis line of pharmaceutical roller compactors for developing and scaling up high volume pharmaceutical products at various manufacturing plants all over the world.

“When we moved our lab from San Francisco to San Rafael the Gerteis Mini-Pactor was the first piece of equipment installed in the pilot plant,” recalls Dr. Mark Menning, Nucleo’s CEO.

“Having the proper equipment in our facility allows us to perform our prototyping then produce GMP supplies using the same equipment. If the product scales up to a larger batch size or a commercial facility, we can simply take the recipes in house then transfer it directly to the contract manufacturer (CMO),” said Mark Menning.

Enhanced client support

Co-founder Lara Park Menning, Nucleo’s COO, says choosing a Gerteis roller compaction solution has enabled them to provide enhanced customer support.

“When selecting equipment vendors, customer support is a critical part of the relationship,” said Lara Park Menning.

“We prioritize client support in our company so we expect the same level of support and passion from our equipment partners. Gerteis has always exceeded with their technical expertise and support. Their machines are indestructible with high performance output,” she noted.

About Gerteis

Gerteis Maschinen + Processengineering AG is a Swiss-based company that has rapidly established itself as a world leader in the field of premium roller compactors. The company’s products and services cover all aspects of dry granulation processes, with unparalleled experience in this field built up since the company was founded in 1986.

Gerteis manufactures a wide range of high quality containment roller compactors that are versatile enough to process a vast range of powders, even notoriously problematic ones at both laboratory and production scales. The company’s patented technologies are widely used by the pharmaceutical, chemical and food industries.

Rapidly increasing demand recently forced the company to move from its original site in Jona on the shores of Lake Zurich to larger and purpose designed premises nearby, in a move completed at the end of 2013.

As well as manufacturing machinery, Gerteis offers complete solution packages that help customers increase productivity including support on identifying ideal formulations and in-house training courses on dry granulation processing. Gerteis constantly seeks to expand its knowledge on dry granulation, participating in numerous research collaborations with German universities.

About Nucleo Life Sciences

Based in the San Francisco Bay Area, Nucleo Life Sciences is a boutique CMO that serves other companies in the pharmaceutical industry, providing assistance with drug development through drug manufacturing.

Nucleo services cover preformulation & formulation development, process development, analytical development & method transfer and scale up & tech transfer.

With more than two decades of experience in the entire idea-to-commercial-release product cycle and seven high-profile drug approvals, Nucleo has established a successful track record of bringing new drugs to market quickly and effectively, using a streamlined product-development process.

Nucleo Life Sciences was founded in 2014 by Mark and Lara Park Menning as an evolution from the California Life Sciences Institute “Cultivating Life Sciences Innovation” lab incubator initiative, moving in 2016 from San Francisco to San Rafael.