Saltigo GmbH is a leading supplier in the field of custom synthesis, offering complete, tailor-made solutions for customers in the crop protection and pharmaceuticals segments and in various non-life-science industries.

This subsidiary of LANXESS is part of the Advanced Industrial Intermediates segment, which generated sales of EUR 1,321 million in fiscal year 2010. Saltigo, headquartered in Langenfeld/Germany with production facilities in Leverkusen and Dormagen, employs around 1,400 staff worldwide. LANXESS Corporation also operates a further site for Saltigo in Redmond (Washington, United States).

Saltigo – Full Life Cycle Pharmaceutical Services API development and manufacturing services

Saltigo serves a broad portfolio of customers: from virtual and emerging biotech’s to large globally active pharmaceutical companies. Our production services range from supply of initial grams to kilograms of advanced intermediates and API’s for preclinical and clinical trials through to pilot quantities and large scale commercial volumes up to hundreds of tons, covering the entire life cycle of your product.

The specific needs of each phase of clinical trials places differing demands on the support services required. To address this Saltigo has developed its suite of services accordingly. The Redmond site is strategically positioned to support projects in the early stages of preclinical studies through Phases 1 and 2a/b of clinical trials. In general product volume requirements are small with decision timelines relatively short and subject to frequent changes. Thus speed and flexibility to ensure on time delivery of high quality products are critical factors in order to ensure project milestones are achieved according to plan.

Saltigo Redmond – Pilotation Facilities

Since the Redmond facility has been acquired in 2008, significant capital improvements in the facility to double the capacity of the kilo and pilot facilities has been made as well as bringing in a highly experienced team in the areas of quality, chemistry and engineering. Today we offer:

  • Chemical Development: Batches up to 20 L (max. 1 – 2 kg / batch)
  • GMP Kilolabs: Batches up to 100 L (max. 5 – 10 kg / batch)
  • GMP Pilot Plant: Batches up to 800 L (max. 20 – 80 kg / batch)

As projects progress through Phase 2 the clinical efficacy is more clearly understood and our focus starts to move towards the development of more commercially viable processes. In this stage we are able to draw on the vast manufacturing expertise and knowledge of the Leverkusen site which has been involved in the development and scale up of small molecules for over 100 years.

Comprehencive Chemistry Capabilitiy

The Leverkusen site has a unique combination of pilot units and larger scale plants which allow scale-up from hundreds of kilograms to hundreds of tons without a site change. The assets are concentrated mainly at one integrated site with an excellent infrastructure, thus reducing regulatory and logistics complexity while minimizing transportation costs for intermediates. Most technologies are available in several multi purpose plants, giving additional supply security. The company has a long track record of successful implementation of chemically and technologically challenging manufacturing processes.

Proven Track Record in COGs Reduction

Saltigo generates additional value for its customers by its strong focus on the reduction of COGs (cost of goods). Innovation is a key driving force as our project teams analyse ways to improve costs throughout the whole product supply chain. Our goal is to access these improvements as early as possible in the life cycle of potential new API’s in order to support our customer’s development and commercialisation activities in ever challenging market dynamics.

In 2010 the Leverkusen site received its most recent FDA inspection which was successfully completed without any 483 observations, highlighting the high quality standard of operation. More recently in 2011 the site received approval from the Japanese Health Authority for the manufacture of non-sterile API’s.