Get to the Clinic Faster
At Lonza, we understand the challenges facing biotherapeutic protein and vaccine manufacturers related to the time and costs inherent in the drug discovery and development process. Light Path™ Microbial Protein Production Services are efficient, focused technology and production offerings for biotherapeutic proteins and vaccines. Light Path™ Microbial Services allow you to leverage Lonza's industry-accepted XS™ Expression Platform, that has met with consistent regulatory approval, to help you meet your Preclinical and Phase I manufacturing needs in a lean, cost-effective manner.
Light Path™ Microbial Services include:
- Gene to non-GMP or cGMP production services
- XS™ Platform for microbial expressed proteins and monoclonal antibodies
- Technology access at a Lonza facility without research license fees
- Protein production for manufacturability, safety and efficacy testing
- Services for a wide range of biotherapeutic and vaccine candidates
Our goal is to help you increase your biotherapeutic protein and vaccine candidates' success throughout the discovery and development process. Our team of experienced and dedicated staff will work with you to design the best Light Path™ Microbial program to meet your protein production needs. We are committed to being your partner now and for future long-term, commercial agreements. Partnering with Lonza allows you to take advantage of our proven microbial expression technology platform and extensive protein development experience, over 30 years and hundreds of biotherapeutic molecules.
Lower your risk, remain flexible and stay focused.
The focused offerings of the Light Path™ Protein Production Services can help reduce the time to IND/IMPD filings.
Rapid Host Screening
Light Path™ Host Screening is a customized service to accelerate the selection of the optimal expression host system for your protein of interest. Our Host Screening Service allows you to make an informed decision regarding which expression system is best suited for your protein production, without the added cost of license fees.
As a host screen customer, your molecule will be expressed in both our Mammalian GS Xceed™ and Microbial XS™ Expression Systems at Lonza's Process Development Centers. The use of production-ready cell lines provides future cost and time advantages when you are ready to manufacture batches for immunogenicity, safety, efficacy, and other Preclinical and Phase I needs.
Light Path™ Host Screening provides rapid identification of your best option, in terms of yield, for successful protein expression. Quick expression system identification will allow you to move seamlessly into small-scale manufacturing with our Light Path™ Discovery Protein Production Service.
Discovery Production Services
Light Path™ Microbial Discovery Protein Production is Lonza's streamlined manufacturing service for the production of small-scale, non-GMP material for your discovery through early development stage needs. Offering includes XS™ Microbial Expression Technology with research access to our system with no license fee while work is performed at a Lonza facility. Our Microbial Discovery service can provide mg quantities of non-GMP product.
Microbial Discovery Service Includes:
- Expression: XS™ System
- Host Strain: Sugar inducible E. coli
- Expression of tagged or untagged native proteins
- Purification: Affinity chromatography to purify tagged proteins
- Product Assessment: SDS-PAGE, SE-HPLC, and Western Blot, as applicable
- Timeline: 4-12 weeks post gene synthesis
- Non-GMP product: 10 - 250 mg
Light Path™ Microbial Discovery Protein Production Service can provide you with sufficient material to facilitate the selection and ranking of lead candidates from discovery phase manufacturability and safety assessments to preliminary in vivo functional studies.
Development Production Services
Cell Line to cGMP in 9 to 11 Months
As you move out of the discovery phase and into clinical development, you will need an increase in the quantity and quality of your product. Our Light Path™ Microbial Development Protein Production Service enables you to continue with Lonza for scale-up and cGMP manufacture of your protein or antibody for Preclinical through IND/IMPD product needs. Research access to our XS™ Microbial Expression System is available with no license fee while the work is performed at a Lonza facility.
Microbial Development Offering Includes:
- Option to use XS™ Technologies or client-provided strain
- Optional non-GMP pilot run
- cGMP scale-up options from 20 L to 70 L
- Multiple site manufacturing options