Microbial Biopharmaceutical Services
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- Sabina George
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1 Pharma&Biotech Your Destination Is Our Goal for Microbial Expression
2 Pharma&Biotech for Microbial Expression Partner of Choice for Microbial Expression Lonza has over 30 years of experience in microbial fermentation for microbial-derived biopharmaceuticals. As a leading manufacturing service provider, we strive to match our customer s requirements with a complete line of service offerings throughout the product development cycle. With our state-of-the-art technology and industry-leading expertise, Lonza has developed an unparalleled track record in establishing high quality, commercially viable processes spanning from pre-clinical development through commercial scale manufacturing. Lonza s Microbial Track Record (1997 Present) Recombinant vaccines Plasmid DNA Antibody fragments Antibody drug conjugates Cytokines Growth factors Hormones Polysaccharide Protein conjugates Products requiring BSL 2 PEGylated products Fusion proteins Protein scaffolds Concatemer peptides 6 Commercially Licensed Projects 89 Pre-clinical & Phase I Projects 26 Phase II/III Projects 2
3 XS Microbial Expression Technology : A Portfolio of Advanced Expression Options XS Technology Tool Box To address the diversity of microbially derived proteins, Lonza has established the XS Microbial Expression Technology Platform, a collection of complementary expression systems that have a proven ability to express recombinant proteins at levels in excess of 20 g/l. The power of our XS Technology is the variety of expression options available to discover the best solution for a given product. XS Expression Technologies E. coli Pichia Bacillus Our portfolio of powerful microbial expression tools encompasses Escherichia coli, Pichia pastoris, and Bacillus subtilis. This diversity of systems enables the delivery of high expression levels for a variety of product types. We use high-throughput screening to identify the best production clone for your product, and have programs designed to go from gene to cgmp production in as little as 7 months. Sugar Inducible GAP Constitutive Sugar Inducible Depletion Inducible Strong Constitutive Auto Inducible Optimized IPTG Inducible Methanol Inducible Glucose Regulated
4 Pharma&Biotech for Microbial Expression Complete Optimization for Better Results When using the XS Technology Platform, you have multiple options for optimizing the expression of your chosen molecule. Each XS Platform offers a range of properties that may be suitable for your selected target. In addition, our XS toolbox allows you to optimize your titers and development timelines while creating a reliable process for future production at increased scale. For customers who are interested in developing their own strains in their facility, our E. coli / sugar inducible system is available under a Research Evaluation Agreement. Lonza s microbial experts will work with you to optimize your expression within the proper host system to provide you with optimal conditions suited to your product. Proven Results for Optimized Yields, Titers and Process Reliability High-yielding Up to 20 g/l for monomeric proteins Up to 1.4 g/l for FAbs Up to 600 mg/l for pdna (6kb) Expression of FAbs with XS Technologies FAb concentration (mg /L) Time (h) FAb 1 FAb 2 FAb 3 Fig. 2 Protein concentration for 10 L fed-batch fermentation runs for three different FAb molecules using the following E. coli XS Technologies : Depletion induction (FAb1), Melibiose induction (FAb2) and Rhamnose induction (FAb3). The cells were harvested, homogenized and the FAb titer was determined by HPLC. Soluble Expression Stable Scalable Fast Inclusion body-free processes Higher yields Reliable DSP No refold tanks Stabilizing genetic elements deliver reliable, predictable & scalable high cell density fermentations Platform fed-batch fermentation procedures are optimized for predictable scale-up Hundreds of host-vector combinations are screened to identify the best production clone within 10 weeks Properties of the Various XS Expression Technology Platforms XS Expression Systems E. coli Pichia Bacillus High Titers Makes Fabs Soluble Expression Stable Scalable Secretes Product Endotoxin Free Lacks Glycosylation Species Approved by FDA Yes Sometimes No «We offer unparalleled versatility throughout your entire development process.» 4
5 Beyond Proteins Plasmid DNA Production Platform: An Integrated Approach Lonza s pdna production platform includes an integrated approach to process development. The platform begins with a unique, fed-batch, high cell density fermentation process compatible with common industry options of E. coli host organisms. This high yielding fermentation process (up to 600 mg/l) is followed by an efficient and economic primary recovery process. Finally, a unique, two column purification platform, based on the differential power of hydrophobic interaction chromatography, has been adopted. Use of this platform process reduces development time required for custom pdna products compared to existing systems. «Innovation is in our nature.» Comprehensive Development Services Lonza understands that the road to an efficient commercial manufacturing process starts with high quality early candidate assessment along with an optimized process development program. Our multi-disciplinary Applied Protein Services and Process Development teams are focused on product manufacturability, economic viability, and conformation to the regulatory requirements right from the beginning. The Services We Offer Include: Immunogenicity prediction, assessment and protein engineering Strain design, construction and selection Strain characterization cgmp cell banking Fermentation and recovery development Refold optimization Filtration and chromatography development PEGylation process and analytical development A full range of analytical development and support Process characterization and validation activities Stability studies Reference standard characterization Regulatory support Non-GMP pilot manufacturing up to 70 L
6 Pharma&Biotech for Microbial Expression Global cgmp Production Our microbial development and production sites offer a wide range of ISO certified and cgmp custom services. Please visit our Virtual Tours at for a comprehensive viewing of our Custom Manufacturing facilities. Visp, Switzerland 20 L, 70 L, L (BL-2 product handling), L (expansion planning under way for additional mid- and large-scale capacity) Cytotoxic fermentation assets: 60 L, 250 L, L Kouřim, Czech Republic L, L, L (oral grade only) Our facilities conform to cgmp standards and have been successfully audited by customers and regulatory authorities. Structured Technology Transfer Through systematic and closely regulated operational and documentation processes, managed by dedicated product managers, we design and implement seamless technology transfer from your facility to our development and manufacturing sites. To date, we have transferred numerous clinical and commercial production processes. These transfers have covered scale-up factors from 5 to over 100 and scales ranging from 20 L to L. Quality Product Management Lonza s dedicated product management is a vital part of your product success. A product manager is your key contact providing continuous effective communication throughout the product lifecycle. Lonza s product management provides an integrated approach across the production value chain: from R&D to logistics and through quality assurance and manufacturing. You will be pleased with the ease of project administration without compromising efficiency or quality. Our commitment to providing you with both time and cost efficiencies during manufacturing will allow you to optimize your project. 6
7 Meeting Your Early Development Needs: Light Path Custom Material Supply The Complete Solution for Your Microbial Needs Light Path Discovery Drug Discovery mg, non GMP In 6 to 10 weeks Preclinical Development Phase I Lonza provides a complete development and manufacturing solution designed to fully realize your product potential in a timely and costeffective manner. With our diverse and proven technology platforms, experienced team of expression specialists and comprehensive product management personnel, we are committed to advancing your microbially derived products from the laboratory to the clinic and beyond. Light Path Development g, non GMP In 4 to 8 month g, GMP in 3 to 6 additional months Our newest service package, called Light Path Custom Material Supply, has been designed for customers whose short-term early stage goals are of paramount importance and who still want access to Lonza s renowned experience, experts, facilities and technologies. This efficient and focused material supply service offering for early stage development of novel biologics gives customers a simpler, faster, and more cost-effective way to obtain biological material. When you are ready to file your IND, you can leverage Lonza s proven technology platforms & expertise to meet your exact early development needs in a lean and speedy manner. Light Path Custom Material Supply Services offer complete gene to GMP production for both the Discovery Phase (mg of material non-gmp) and Development Phase (mg to kg of non-gmp and GMP material). Light Path allows you to partner with Lonza early and be on the road to a marketable product. Light Path Discovery Offering Includes: Options to use XS Technologies or client-provided strain Expression of tagged or untagged native proteins Affinity chromatography to purify tagged proteins No license fees Light Path Development Offering Include: Option to use XS Technologies or client-provided strain GMP Scale-up options from 20 L to 1000 L No license fees 7
8 Europe Lonza Ltd Muenchensteinerstrasse Basel, Switzerland Tel USA Lonza Inc. 90 Boroline Road Allendale, NJ Tel The information contained herein is believed to be correct and corresponds to the latest state of scientific and technical knowledge. However, no warranty is made, either expressed or implied, regarding its accuracy or the results to be obtained from the use of such information. Some products may not be available in all markets or for every type of application. Any user must make his own determination and satisfy himself that the products supplied by Lonza Group Ltd and the information and recommendations given by Lonza Group Ltd are (i) suitable for intended process or purpose, (ii) in compliance with environmental, health and safety regulations, and (iii) will not infringe any third party s intellectual property rights Lonza Ltd
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