Lonza Expands Service Offerings for Early Phase Biopharmaceutical Drug Development
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Lonza announced that it has launched four new service offerings to help early stage global customers de-risk and progress their clinical candidates. These four services, which have been launched from Lonza’s development facilities in Slough and Cambridge (UK), include Protein Sequence Variant Analysis, Site Specific Conjugation Vectors, Cell Line Construction options and Developability Assessment for Microbial-Expressed Proteins.
Protein Sequence Variant Analysis
Expression systems are prone to generate protein sequence variants, which may lead to adverse events in patients. Typically, variant analysis is performed in Phase II/III. Finding variants at an earlier stage avoids the need for costly rework which can have a potentially significant impact on the project timeline. Lonza’s new Protein Sequence Variant Analysis offering uses class-leading mass spectrometry methods including Electron-Transfer Dissociation and Ultra-High-Resolution Orbitrap mass detection at cell line selection that conclusively de-risks clinical candidates.
Site Specific Conjugation Vectors for the GS Xceed®System
First-generation antibody drug conjugates (ADCs) have development challenges, including non-uniform and non-optimized drug-to-antibody ratio (DAR). Lonza’s Site Specific Conjugation (SSC) Vectors, designed for use with the GS Xceed® System, are an easy way to produce conjugation-competent antibodies that have a defined number and location of bioconjugate attachment points. These vectors were modified to contain a single-point cysteine mutation in the constant region of an immunoglobulin heavy or light chain. The conjugation sites have been assessed for aggregation and immunogenicity impact. In conjunction with Lonza's pCon Plus Vectors, antibody libraries with fine-tuned conjugation capabilities and DAR of 0, 2 and 4 can be constructed using standard thiol chemistry under mild conditions.
Cell Line Construction (CLC) Options
A key factor in reducing the production costs of biopharmaceuticals is the development of cell lines that produce a high yield of product with the desired critical quality attributes. Using its GS Xceed® Gene Expression System, Lonza offers a flexible approach to match customer milestones in terms of scope, timelines, yield optimization and risk. Lonza’s newest CLC option is Multiplex CLC, which allows the cost-effective progression of multiple candidates at an early stage while the final selection process is ongoing. This package saves four to six months from a traditional development program. Multiplex CLC is complemented by Lonza's existing CLC options, which include Full Scope or LightPath™ CLC.
Developability Assessment Platform for Microbial-Expressed Proteins
Screening of potential candidates in the discovery process will help reduce costs, risk through attrition and overall development time. Being able to assess the manufacturability and safety at the pre-clinical stage, before large investments are made, allows companies to focus on the most-promising candidate and maximize R&D spending.
Lonza’s proven Developability Assessment Platform has been expanded to now include capabilities for both mammalian and microbial-expressed proteins. This in silico assessment supports selection of the best candidate, optimizes the development process and ensures a rapid and cost-effective drug development strategy.
“Our approach at Lonza is to provide services that help our customers develop more efficacious molecules, manage the risk of biopharmaceutical development and enhance the chance of clinical success,” said Karen Fallen, Vice President, Business Unit Head, Clinical Development for Lonza. “By incorporating our new service offerings earlier in their programs, the data provided will help our customers select the most suitable candidate and ultimately, keep their program on time and on budget.”
Protein Sequence Variant Analysis
Expression systems are prone to generate protein sequence variants, which may lead to adverse events in patients. Typically, variant analysis is performed in Phase II/III. Finding variants at an earlier stage avoids the need for costly rework which can have a potentially significant impact on the project timeline. Lonza’s new Protein Sequence Variant Analysis offering uses class-leading mass spectrometry methods including Electron-Transfer Dissociation and Ultra-High-Resolution Orbitrap mass detection at cell line selection that conclusively de-risks clinical candidates.
Site Specific Conjugation Vectors for the GS Xceed®System
First-generation antibody drug conjugates (ADCs) have development challenges, including non-uniform and non-optimized drug-to-antibody ratio (DAR). Lonza’s Site Specific Conjugation (SSC) Vectors, designed for use with the GS Xceed® System, are an easy way to produce conjugation-competent antibodies that have a defined number and location of bioconjugate attachment points. These vectors were modified to contain a single-point cysteine mutation in the constant region of an immunoglobulin heavy or light chain. The conjugation sites have been assessed for aggregation and immunogenicity impact. In conjunction with Lonza's pCon Plus Vectors, antibody libraries with fine-tuned conjugation capabilities and DAR of 0, 2 and 4 can be constructed using standard thiol chemistry under mild conditions.
Cell Line Construction (CLC) Options
A key factor in reducing the production costs of biopharmaceuticals is the development of cell lines that produce a high yield of product with the desired critical quality attributes. Using its GS Xceed® Gene Expression System, Lonza offers a flexible approach to match customer milestones in terms of scope, timelines, yield optimization and risk. Lonza’s newest CLC option is Multiplex CLC, which allows the cost-effective progression of multiple candidates at an early stage while the final selection process is ongoing. This package saves four to six months from a traditional development program. Multiplex CLC is complemented by Lonza's existing CLC options, which include Full Scope or LightPath™ CLC.
Developability Assessment Platform for Microbial-Expressed Proteins
Screening of potential candidates in the discovery process will help reduce costs, risk through attrition and overall development time. Being able to assess the manufacturability and safety at the pre-clinical stage, before large investments are made, allows companies to focus on the most-promising candidate and maximize R&D spending.
Lonza’s proven Developability Assessment Platform has been expanded to now include capabilities for both mammalian and microbial-expressed proteins. This in silico assessment supports selection of the best candidate, optimizes the development process and ensures a rapid and cost-effective drug development strategy.
“Our approach at Lonza is to provide services that help our customers develop more efficacious molecules, manage the risk of biopharmaceutical development and enhance the chance of clinical success,” said Karen Fallen, Vice President, Business Unit Head, Clinical Development for Lonza. “By incorporating our new service offerings earlier in their programs, the data provided will help our customers select the most suitable candidate and ultimately, keep their program on time and on budget.”
