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Focus on robust product design

 

We provide integrated design, development and manufacturing services in bioavailability enhancement, modified and targeted drug delivering, and low dose / highly potent applications. Our services are designed to meet the challenges you face in advancing your molecules to the next development milestone. We focus on specialty and enhanced drug products with premier capabilities in bioavailability enhancement and low dose/highly potent applications.

We are uniquely positioned to develop customized approaches in meeting your target product profile. We utilize an integrated product development model, from early stage feasibility and product design through clinical and commercial manufacture of finished drug products –giving our customers the option of a single partner throughout the development to minimize timelines, complexity and risk.

 

Oral Drug Products and Intermediates Design Development and Manufacturing Process

Our multi-disciplinary project teams – engineers, material scientists, chemists, biologists, mathematicians and pharmacists – bring a unique perspective to drug development programs.

Science & engineering – a core competency

We’ve developed proprietary processes and equipment to successfully advance formulations using enabling technologies. Extensive science-of-scale studies across our technologies have not only supported rapid scale-up to clinic and commercialization, but also enabled the design of specialized lab-scale equipment to efficiently support feasibility and early clinical studies.

Our flexible product developmentapproach and business models means we can provide exactly what our customers need. We can design and produce a full range of drug substances, drug product intermediates and finished drug products.

Our integrated product development and manufacturing locations ensure seamless product development, accelerated timelines and certainty of supply.

Phase-appropriate services


We start by gaining a full understanding of your compound, target product profile and objectives. Phase-appropriate services and processing are in place so that you get exactly what you need in the timeline required. Whether your requirement is first-in-human, formulation optimization, or rapid scale-up, your next milestone is our focus - let's get there together.

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Product Design and Preformulation Development
We apply extensive product design, preformulation, and technology expertise to successfully advance challenging compounds and improve overall speed to market. We offer premier depth in addressing bioavailability challenges and modulating pharmacokinetics ...
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Regulatory Affairs Services
Our Regulatory Affairs Services provides an extensive CMC writing and procedural offering to clients. We use our hands-on practical experience from early development through clinical programs (IND & IMPD), support for preparation and approval of license a...
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SimpliFiH® Solutions: First-in-Human Services
We can provide integrated drug substance and drug product services for preclinical studies and phase I clinical trials.
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BA Enhancement
The depth of our bioavailability enhancement offering makes us a leader in addressing drug solubility and dissolution rate issues.
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Particle Engineering Services
Particle engineering is increasingly required to prepare active pharmaceutical ingredients for effective drug product formulation for oral solid and inhaled applications.
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Formulation and Product Development
We provide integrated preformulation, formulation and product development services to our biopharmaceutical customers using a broad range of enabling technologies to address formulation challenges.
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Pediatric Product Development
We provide specialized product development for pediatric and geriatric populations.
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Low Dose and High Potency Applications
Liquid and semi-solid fill technologies are proven approaches for safely handling HPAPI and achieving low dose content uniformity. HPAPI is a core focus area of Lonza and we provide fully integrated services from drug substance to specialized oral solid d...
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Modified and Targeted Delivery
We utilize a full range of established modified release technologies, often in combination with solubility-enhancing technologies, to meet target product profiles.
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Drug Product Process Development and Optimization
We provide process development, optimization and validation as part of its integrated services spanning feasibility studies, clinical trial material manufacture and commercial production of drug substances, intermediates and finished drug products.
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Clinical Trial Material Manufacture
As part of our integrated product development services, We provide clinical trial material across small molecule applications for early and late phase clinical trials.
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CMC and Scale-Up
To produce a pharmaceutical dosage form, manufacturing processes, product characteristics, and product testing must be specifically defined to ensure that the product is safe, effective, and of consistent quality.
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Commercial Manufacture of Drug Products & Intermediates
As part of our integrated product development services, we provide commercial scale production for all of our oral solid product options from a global network of eight sites.
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Clinical Packaging and Supply Services
Highly specialized activities are needed to coordinate, package, and distribute clinical supplies to be dispensed to patients in a timely and controlled manner. Effective clinical-trial supply management can make the difference between success and a faile...
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Small Molecule Parenteral Formulation Development
Our Drug Product Services team (Lonza DPS) offers a smart approach that considers the interplay between solubility, local tolerance and systemic toxicity for rapid and successful development of your parenteral small molecule program.
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Small Molecule Parenteral Manufacturing
Our Drug Product Services (Lonza DPS) team manufactures GMP liquid and lyophilized parenteral small molecule drug product batches for clinical and commercial supplies, as well as non-GMP batches for toxicological and stability studies, in addition to refe...

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We know more about product design for challenging compounds because we’ve done more. Lonza has formulated thousands of compounds and encountered a myriad of bioavailability, pharmacokinetic and other formulation and processing challenges.

Technologies and products

 

We have the full range of technologies in-house to address solubility or dissolution rate, modulate drug release, and meet your target product profile. This has enabled us to develop technology selection methodologies based on proprietary databases, predictive models and expert systems to use in place of empirical screening. The result –rapid application of enabling technology to fit a specific compound, thereby accelerating development and clinical timelines while minimizing API requirements.

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Chemical Synthesis Technologies
We master an extensive array of chemical platforms and technologies.
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Colonic Delivery
We combine our expertise in encapsulation and targeted delivery to the gastro-intestinal track to achieve effective colonic delivery.
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Delayed Release and Enteric Protection
A number of drug products require formulation strategies to either target the upper gastrointestinal tract for optimized absorption, protect the stomach from APIs that are gastric-irritating, and/or protect acid-labile APIs from the acidic conditions of t...
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Hot Melt Extrusion
Hot-melt extrusion (HME) technology is an established solid dispersion technology for improving dissolution rate and solubility, and a component of our premier bioavailability enhancement services.
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Lipid and Liquid-Based Formulations
Our lipid and liquid-based formulation services provide flexible, fit for purpose solutions to a wide range of formulation challenges including solubility / bioavailability improvement, addressing food effect, low dose applications, colonic delivery and a...
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Liquid-Filled Hard Capsule Technology
Liquid-filled hard capsule technology has a proven track record in addressing a range of complex formulation challenges inclusive of solubility/bioavailability and low dose/highly potent issues. We provide integrated services for LFHC development and manu...
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Micro-dosing for Powder-in-Capsule / Powder-in-Bottle Studies
Micro-dosing is the process of dispensing a precise amount of drug substance into a capsule (or other container, e.g. vial or bottle), for use in early phase human studies (phase I safety evaluations). This powder-in-capsule (PIC) or powder-in-bottle (PI...
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Micronization & Jet Milling
Particle size reduction is increasingly utilized to address a range of formulation issues facing oral solid and inhaled dosage forms. Stability, flowability, dissolution rate and bioavailability are critical performance parameters impacted by particle siz...
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Multiparticulate Technologies
We utilize four multiparticulate technologies for meeting target product profiles, with the choice being dependent upon API parameters, formulation requirements and commercial objectives.
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Osmotic Tablet Technologies
We use two osmotic tablet technologies that are highly flexible, can be utilized with both crystalline and amorphous drug substances, and utilize osmotic/hydrostatic pressure to provide consistent drug release without food effect.
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Soft Gelatin Capsules
Softgels provide an important dosage technology that can be highly beneficial in addressing a wide array of formulation challenges, such as bioavailability enhancement and low dose/HPAPI applications including hormones.
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Solid Dispersion Technology
Amorphous solid dispersions are a proven approach to alter the properties of APIs for improved dissolution rate, solubility and overall bioavailability.
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Spray Drying Technology
Pioneered for pharmaceutical applications by Bend Research (now Lonza), spray drying has emerged as a primary technology for addressing poor dissolution rate, solubility and bioavailability.
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Taste and odor masking
Effective taste and odor masking has been shown to have a marked effect on patient compliance, especially for specialized patient populations such as pediatrics and geriatrics.
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Technology Selection
We have developed models, reference tools and methodologies to accelerate technology selection for BCS II compounds.

oral drug products and intermediates


our global footprint

Our global network of eight Centers of Excellence span across three continents. This network provides integrated development and manufacturing for drug substances, drug product intermediates based on particle engineering, and oral solid drug products. Each site has phase-appropriate processing in place for feasibility studies through commercialization.

Visp, Switzerland

Production, Research & Development, Sales & Support

Visp 3930
Switzerland

Nansha, China

Production, Research & Development

Huangge N Ave
Guangzhou, Nansha 511455
China

Quakertown, PA

Production

20 Pacific Dr.
Quakertown, PA 18951
United States of America

Monteggio, Switzerland

Production, Research & Development, Sales & Support

Via Cantonale 4
Monteggio 6998
Switzerland

Bend, OR, USA

Production, Sales & Support, Research & Development

1201 NW Wall St.
Bend, OR 97703
United States of America

Ploërmel, France

Production, Research & Development

ZI de Camagnon
Ploermel 56800
France

Edinburgh, Scotland

Production, Research & Development

Oakbank Park Way
Units 4,5 & 6
Livingston EH53 0TH
United Kingdom

Tampa, FL, USA

Production, Sales & Support

4910 Savarese Circle
Tampa, FL 33634
United States of America