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Like no other business, pharmaceutical firms demand complete assurance around the purity, consistency, and repeatability of downstream process systems. The sensitive handling of small-molecule compounds—during development and "at-scale"—present you with a unique set of challenges.
At LEWA, we understand the need to fast track APIs to market and streamline validation activities. That's why we offer you decades of experience meeting the most stringent pharmaceutical demands. Our proven portfolio of product solutions can be quickly and efficiently put to work for you—by a team of engineers who've spent their careers serving your industry.
We confidently supply HPLC systems >100 bar (1450 psig) pressure—leveraging a 60-year history of supplying high pressure precision pumps to the world’s largest companies. LEWA pumps have been recognized as industry-standard on hundreds of HPLC, LPLC, SMB, SFC and blending units since the 1980’s.
For customers performing chiral separations, our Simulated Moving Bed (SMB) systems combine our in-house expertise with an exclusive license to breakthrough patented technology from with Bayer Technology Services (BTS).
NEW! The fastest way to improve yeild and purity is via MCSGP, impure product-containing side fractions are automatically recycled in a periodic closed loop process (see animation here). Thereby, the yield of pure product is maximized. This allows for a significant improvement in process economics. MCSGP gives higher yield and purity than batch chromatography. Under license by ChromaCon AG, LEWA is now providing MCSGP at pilot and production scale.
MCSGP is for example used for:
- blood plasma products
- recombinant proteins from microbial production
- small molecules from fermentation or natural product extractions (Stevia, Flavonoides, fish oil)
- synthetic peptides
- complex organic synthesis products
The MCSGP technology is patented by ChromaCon
LEWA HPLC products are fabricated from 100% stainless steel and come with polished finishes to satisfy the most exacting specifications (e.g. Single-digit Ra). Highly-calibrated LEWA Intellidrive ® pumps and LEWA Process Technologies’ open-architecture control systems provide ultimate protection of sensitive products. Flexible COP, CIP and SIP capabilities enable optimal efficiencies and support absolute product integrity.
We routinely deliver significant efficiency gains by reducing the footprint of systems—or even the number of systems—required to produce your product, often by more than 50%. The precision of our pumps and highly-calibrated controls often allow one LEWA Process Technologies solution to do the work of three traditional systems. Our solutions are customized to your process.
Representative solutions include:
- API purification by chromatography or filtration
- Precision blending
- Chiral separations by SMB
- HPLC and MPLC systems
- Migration of batch to continuous processing
- Explosion-proof design, fabrication and automation process systems
- Flexible, scalable chromatography—from pilot to process systems
- Simulated Moving Bed (SMB) systems
Managing solvents and high-purity or volatile chemicals is a particular competency of ours. We routinely design high and low pressure systems to safely and efficiently meet safety codes such as:
- Class 1, Division 1;
- Class 1, Division 2; and
- ATEX Zones 1 and 2.
By maintaining a comprehensive vertical supply chain, we provide tight control over quality from the base pump unit to the automation and all the in-house manufacturing controls to at customer installation - LEWA Process Technologies lets you avoid multi-supplier finger pointing. We guarantee commercial and process certainty. And with a global network of specialists from Singapore to Tokyo—Zurich to Dublin—and Boston to San Diego, you're always close to a local LEWA – Nikkiso contact—along with an assurance of commercial and process certainty.
We welcome the chance to lower your total cost of ownership (TCO), speed your time-to-market, reduce your line's footprint, and improve product consistency and integrity. We can provide full project support, supply you with groundbreaking products, or provide in-place retrofit services.