Inhalation Formulation Services

We provide customized chemical synthesis for active pharmaceutical ingredients from concept to commercial supply.

We are an industry-leading integrated development and manufacturing service provider for small molecule drug substances and their intermediates.

Chemistry is core to us. Our track record in producing API and intermediates extends back to the genesis of contract development and manufacturing. Thousands of compounds have been successfully developed and progressed by our R&D, process development and manufacturing teams. Many of these molecules have been scaled under accelerated timelines to meet program objectives. 

We have an established history and ongoing service programs with the full range of customers from virtual companies to big pharma. Our development and manufacturing services for APIs routinely support:

• drug substances requiring advanced synthesis expertise and process development
• late phase clinical programs requiring the scale and expertise provided by Lonza for rapid API commercialization
• highly potent compounds requiring our specialized infrastructure and handling capabilities
• ADC payloads with the option of integrated services inclusive of monoclonal antibodies, inkers and conjugation services.  

Phase-appropriate assets support all phases of drug substance development and supply.

HPAPI product handling from concept to commercial-scale manufacturing 

Utilizing a combination of technology, infrastructure and expertise, we provide you with seamless, flexible HPAPI development and manufacturing tailored to your specific needs and resulting in reduced program timelines, complexity and risk.

 
Helping you combat significant handling challenges 

Highly potent APIs and drugs are increasingly prevalent in the drug development pipeline driven by oncology research and more targeted therapies across a number of indications. These high potency drug candidates represent a significant change in the way innovators are using small molecules to deliver new patient therapies.

This shift toward the use of HPAPIs has led to a pipeline of more effective medicines, with potentially lower dose requirements and/or fewer side effects. This trend towards HPAPI manufacturing also presents significant handling challenges for innovators and their development & manufacturing partners.

 
Development services for highly potent API across all standard chemical reactions for highly potent applications to 1 ng/m3.  

With more than 20 years of experience in high potency drug handling and multiple HPAPI was taken from early to late-stage development and commercialization. We understand that simply having some reactors in high containment is not enough to manage the modern requirements for manufacturing HPAPI and intermediates. At our Center of Excellence for HPAPI development and manufacturing in Visp, CH, we have a comprehensive platform in place utilizing a highly skilled team, extensive evaluation and training procedures and state of the art facilities for optimized HPAPI development and scale-up. 

HPAPI product development and manufacturing is a core strength of Lonza. We have an excellent track record and industry-leading capacity for HPAPI manufacturing with complementary strengths in contained particle engineering and specialized dosage forms for low dose / HPAPI applications.

We also develop and manufacture ADC payloads at our Visp location, and provide integrated development and manufacturing across antibodies, payloads, linkers and conjugations, and sterile fill-finish.

The depth of our bioavailability (BA) enhancement offering makes us a leader in addressing addressing low solubility, low bioavailability and dissolution rate issues. We work collaboratively with our customers to advance compounds, or re-purpose existing compounds, across a full range of API properties and delivery challenges. Our end-to-end solutions incorporate full capabilities in bringing a compound from concept to commercialization, thereby minimizing program complexity, timelines and risk.

Industry estimates indicate that more than 80% of new chemical entities exhibit low solubility, low bioavailability and / or low or inconsistent dissolution rate. Effectively addressing these drug solubility, bioavailability and dissolution rate problems is essential for advancing the compound and providing the desired therapeutic benefit of the drug product to patient. And ensuring that the solubility solution incorporates the ultimate manufacturability of the drug product can avoid time-consuming re-formulation and rapid advancement to market.

We recognize the core challenges of advancing the new chemical compounds in today’s biopharmaceutical pipeline. That’s why we have developed a portfolio of bioavailability enhancement technologies and services with which to address poor solubility and inadequate or inconsistent dissolution rate.

Our commitment to our customers includes a 20+ year track record across our bioavailability enhancement approaches with phase-appropriate processing in place to support non-GMP feasibility assessments through GMP clinical trials and commercial-scale manufacturing.
Proven bioavailability enhancement technologiesOur bioavailability enhancement technologies include:

Particle size reduction: micronization and nano-millingSolid dispersion technologies: hot-melt extrusion or spray dryingSpecialized nanocrystalline dispersion and spray-dried nanoadsorbate technologiesComplementary drug delivery technologies are utilized to modulate pharmacokinetics of the solubilized compound and achieve a full range of absorption profiles.

Our scientists take a data-driven approach to characterizing BA problem statement(s) and selecting the enabling technology to advance your compound.

Our integrated product design and development services provide the full range of capabilities to support the rapid advancement of compounds from concept to clinic. This range of services has been integrated in our SimpliFiH® Solutions offering designed to be phase-appropriate and to simplify your pathway to IND/IMPD studies:

• API development and supply
• API characterization
• Product design and preformulation development
• Formulation and product development
• Analytical services and quality control
• Clinical trial manufacture
• Clinical packaging and supply services

Additionally, our SimpliFiH® Solutions integrated service package is designed specifically to rapidly advance compounds to first-in-human studies.

Use of Microreaction Technology (MRT) may lower product cost of goods and increases yield and throughput of a manufacturing facility. This technology is able to perform hazardous, high temperature and pressure reactions, as well as those containing unstable or extremely reactive elements. Using MRT, these types of reactions can be safely operated under intensified process conditions.

At any point along your product development path, Lonza—™s Bioassay Services can help clients with immediate support for specific biological assay development. We work with our clients to overcome any quality, regulatory, or security challenges. For biopharmaceutical and cell therapy manufacturing, Lonza is the premier partner to accelerate market entry. We are driven to help clients reduce the overall time and cost of product development.

Our facilities are accredited with AAALAC, registered with OLAW, PHS and USDA. Multiple species (large and small) are available for most services. We offer both GLP and Non-GLP compliant studies.

Lonza Biologics Inc offers wide range of pharma products and services which includes biological assays. It belongs to pharma & biotech, bioassay services category. It includes cell proliferation, cell permeability, apoptosis, cell differentiation, cell survival/cytotoxicity, immunoassays: elisa, flow cytometry (4 colors), adcc (antibody dependent cell mediated cytotoxicity, etc.

Lonza Biologics Inc offers wide range of pharma products and services which includes biopreservation, fill and finish. It belongs to cell therapy products and services category. It recognize the unique time constraints associated with converting a cultured cell harvest into a formulated cell therapy product.

Lonza Biologics Inc offers wide range of pharma products and services which includes cho cell media. It belongs to upstream serum-free media and feed formulations services and products category. Contact us for more information.

Lonza Biologics Inc offers wide range of pharma products and services which includes nucleofector™ devices. It belongs to bioresearch transfection services and produtcs category. It includes 4d-nucleofector™ system, 96-well shuttle™ system, ht nucleofector™ system, nucleofector™ 2b device. It each optimized cell type and can be selected via the device or PC software. We offer three different device platforms plus an add-on device.

Lonza Biologics Inc offers wide range of pharma products and services which includes custom powdered media . It belongs to upstream serum-free media and feed formulations services and products category. Features: non animal origin facility, relative humidity, consistent particl size distribution, batch capacity 7.25kg - 7,290kg, temperature control, high speed impact, automatic cleaning in place, regulatory friendly, avoid clumping and reduces bioburden, excellent solubility, pilot batches to commercial scale, protection of sensitive chemicals.

Lonza Biologics Inc offers wide range of pharma products and services which includes nucleofector™ kit accessories. It belongs to bioresearch transfection services and produtcs category. . It includes nucleofector™ plus supplement, mouse t cell nucleofector™ medium, pmaxcloning™. It is caused by donor variance, isolation process or cell culture by using nucleofector™ plus Supplement for cryopreservation of larger cell batches in nucleofector™ solution.

Lonza Biologics Inc offers wide range of pharma products and services which includes human mesenchymal stem cells & media. It belongs to primary and adult stem cells adult stem cells & media services & products category. It includes hmsc human mesenchymal stem cells, hmsc mesenchymal stem cell adipogenic differentiation medium, hmsc mesenchymal stem cell chondrocyte differentiation medium, hmsc mesenchymal stem cell osteogenic differentiation medium, mscgm™ mesenchymal stem cell growth medium, therapeak™ mscgm-cd™ mesenchymal stem cell medium, chemically defined.

The new production line at Guangzhou site will supply global and domestic companies with clinical and commercial batches

Enabling a healthier world.

Tech transfer is a crucial phase that converts clinical promise into commercial gain but pressure on sponsors to reduce time to market in the age of COVID-19 means CDMOs have to be on top of their game to deliver. What are the latest innovations to solve tech transfer challenges?

Lonza Quakertown provides expertise in particle size reduction and classification servicing the cGMP pharmaceutical marketplace. The presentation will provide a description of the site and an overview of capabilities specific to micronization and classification while highlighting the value of particle size reduction and control. The basic mechanics of jet milling will be explored along with process development and process scale-up. The presentation will conclude with a discussion of the option of combining micronization services with other platforms and technologies within Lonza as an integrated service offer. This session was originally broadcast live as part of CPhI North America 2021

Opportunities for contract development and manufacturing organisations (CDMOs) in China continue to grow but many questions remain over what the future of the sector will look like in the world's second largest pharmaceutical market.

Our facilities in Tampa (FL) US are an integral component of Lonza’s design, development and manufacturing network for drug substances and specialized drug products. Working collaboratively with our customers, our Tampa team designs develops and manufactures oral solid and inhalation drug products. The site provides a full range of services, starting from the initial stages of product development including pre-formulation, formulation & process design, and analytical method development. These services extend into early phase clinical, late phase clinical, and commercial-scale production including packaging and distribution worldwide. Tampa also serves as our US Center of Excellence for rapid first-in-human services utilizing Powder-in-Capsule (PIC) based on our proprietary Xcelodose® Precision Powder Micro-Dosing Technology to effectively increase speed-to-clinic initiatives. Site accomplishments: PIC to Commercial (ALUNBRIG), DEV to Commercial +$20M in renovation Site center of excellence: FIH Initiatives for Speed to Clinic Unit operations same for inhalation (XD, Harro) Cross site case studies (TBD) – VISP/QT/TPA Site expansion: Containment & Unit Operations OEB levels and containment (multi-use, unit op specific) Extension of service: Inhalation Testing Leverage Bend CoE for inhalation development Analytical capabilities employed 2021 This session was originally broadcast live as part of CPhI North America 2021

Explore the series of Learning Labs at CPhI North America across several product innovation categories in which thought leaders at our exhibitors showcase their extensive expertise in all areas of the pharma supply chain, offering industry insights across drug manufacturing, outsourcing, pharma ingredients, drug delivery and packaging.

A large and increasing fraction of orally administered small molecules in pharma company pipelines have poor oral absorption due to low aqueous solubility or dissolution rate. To address this trend, evaluating formulation approaches for increasing oral bioavailability are becoming routine early on in formulation development programs. Selecting the appropriate technology for your compound requires careful consideration of the compound physicochemical properties, target dose and pharmacokinetic profile, as well as overall market image. In this on-demand webinar, hear about some of the most common bioavailability-enhancing technologies for poorly soluble compounds and a strategic framework for identifying and selecting the appropriate technology. A case study is presented.

The expansion of mid-scale capacity will enable the company to offer a smooth transition between early-phase and large-scale commercial production

With the pharmaceutical industry’s focus on accelerating all aspects of drug discovery and development, it is crucial to reduce the time from initial product concept to first-in-human clinical completion. Numerous factors can slow this process, but challenges can be overcome by aligning with a single, integrated Contract Development and Manufacturing Organization (CDMO) to reduce the time, complexity, risks, and costs associated with engaging multiple partners.

While the COVID-19 pandemic has created even greater demand for partnerships, CDMOs need to be aware that the needle has shifted, creating both opportunities and challenges and changing how the services industry does business

Solid-form screening and characterization is a crucial part of drug substance development and pre-formulation. In this webcast, experts will discuss many aspects of solid-form screening including in-silico screening, which can save time and speed up the solid-form development process. A case study will review the in-silico screening of cocrystals of a pharmacophore using hydrogen bond energies and hydrogen bond propensities. A second case study will examine the cocrystallization of nutraceuticals and their versatile use as conformers.

Drug substance production line expected to be operational by end of 2021 as part of CDMO’s expanded collaboration with biotech

Three additional drug substance manufacturing lines will be added to existing ones at Swiss site and are expected to be operational in early 2022

CHF 200 million investment will include dedicated line for antibody-drug conjugate payload molecules and is scheduled to start operations in Q3 2023

The antibody-based products will be expressed using Lonza's GS Xceed Gene Expression System

Ploermel and Edinburgh facilities employ around 390 permanent staff and will allow UK CDMO to expand its technology offering

The CDMO will provide cell line development, process development, drug substance and drug product manufacturing for Pionyr’s monoclonal antibody candidate

PsiVac has generated compelling efficacy data in killing a broad range of tumour cells, including head and neck, bladder, liver, pancreatic and ovarian

The expanded and refined first-in-human services have been designed to meet the early-stage molecule development of small biopharma players

Private equity firms Bain Capital and Cinven to buy the CDMO's specialty ingredients business

CDMO will add two production suites for clinical and commercial supply and extend lab space to double analytical and process development capacity

The company will invest in dedicated early-phase development and cGMP manufacturing to help customers rapidly advance challenging molecules

Altimmune adds Lonza as a manufacturing partner for supply of AdCOVID, its single-dose intranasal vaccine candidate for COVID-19.

Ingredients are the lifeblood of the pharmaceutical and nutraceutical industries. They connect today’s cutting-edge medicine and consumer products makers with their origins in the chemicals sector of the late nineteenth century. While ingredients play a major part in determining whether a pharmaceutical or nutraceutical product is effective, they do not do it alone. How an ingredient is formulated is critical to the success of a prescription medicine or OTC product, both therapeutically and from a commercial standpoint.

As respiratory diseases continue to be a leading cause of death and disabilities across the globe, inhalation drug products play a significant role in treatments. Particle engineering innovations can help keep these medicines affordable and patient-centric.
In this article read how choosing the right technology for particle engineering helps life-saving therapies reach patients faster. Understanding API properties, target drug profiles and potential risks all play a role in choosing the right particle engineering technology, such as spray drying or micronization.