Active Pharmaceutical Ingredients and Intermediates

Active Pharmaceutical Ingredients and Intermediates
Product Description

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.

Lonza

  • CH
  • 2015
    On CPHI since
  • 5000+
    Employees
Company types
Contract Service
Manufacturer/Innovator

Lonza

  • CH
  • 2015
    On CPHI since
  • 5000+
    Employees
Company types
Contract Service
Manufacturer/Innovator

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Lonza resources (36)

  • News Lonza signs five-year collaboration deal with VC firm Bioqube to speed up portfolio companies’ development and manufacturing

    The offering will accelerate timelines for the development and manufacturing of molecules and disruptive technologies
  • Brochure Presentation: Achieving Bioavailability Enhancement for Poorly Soluble Compounds

    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.
  • News Lonza Switzerland site to undergo expansion of microbial development capabilities

    The expansion includes the installation of a pilot suite with a 50-L fermenter and automation upgrades to accelerate clinical and commercial projects
  • Brochure Presentation: Solid form screening and rational cocrystal design

    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.
  • News Lonza boosts exosome capability with Codiak BioSciences facility acquisition

    The companies will establish a Centre of Excellence focused on exosome manufacturing and characterization technologies
  • Whitepaper White Paper: SimpliFiH®️ Solutions for Accelerated Pharmaceutical Development

    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.
  • News Lonza to establish multi-product fill and finish line in China

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

    Enabling a healthier world.
  • News Tech transfer: a many-layered artform that demands precision and communication

    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?
  • Video Lonza Quakertown - Micronization and Particle Size Control

    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
  • News CPHI Trend Report - CDMO Opportunities in the Chinese Market

    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.
  • Video Lonza Tampa - Expansions in HPAPI for Oral Solid and Inhalation Technology

    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
  • News Discover the CPHI North America Learning Labs: Part One

    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.
  • News Lonza to invest in mid-scale API manufacturing expansion at Chinese facility

    The expansion of mid-scale capacity will enable the company to offer a smooth transition between early-phase and large-scale commercial production
  • News Pandemic creates extra demand for CDMO services but investment decisions remain key to success

    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
  • News Lonza to install new production line at Geleen to increase Moderna COVID-19 vaccine output by 300 million doses per year

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

  • News New Moderna agreement will double vaccine drug substance production at Visp, says Lonza

    Three additional drug substance manufacturing lines will be added to existing ones at Swiss site and are expected to be operational in early 2022
  • News Lonza to build small molecule manufacturing complex at Visp site

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  • News Lonza and Junshi Biosciences expand biologics manufacturing collaboration

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  • News NextPharma completes purchase of Lonza lipid oral dosage form manufacturing sites

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  • News Lonza to support Pionyr Immunotherapeutics' oncology drug development

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  • News Lonza to develop and manufacture Ixogen's oncolytic virus

    PsiVac has generated compelling efficacy data in killing a broad range of tumour cells, including head and neck, bladder, liver, pancreatic and ovarian
  • News Lonza boosts solid form services for small molecule APIs

    The expanded and refined first-in-human services have been designed to meet the early-stage molecule development of small biopharma players
  • News Lonza repositions as pure play healthcare firm after specialty unit sale

    Private equity firms Bain Capital and Cinven to buy the CDMO's specialty ingredients business
  • News Lonza to expand bioconjugation capabilities at Visp site

    CDMO will add two production suites for clinical and commercial supply and extend lab space to double analytical and process development capacity
  • News Lonza expands development and manufacturing capabilities at Bend site

    The company will invest in dedicated early-phase development and cGMP manufacturing to help customers rapidly advance challenging molecules
  • News Altimmune signs up Lonza to manufacture intranasal COVID-19 vaccine

    Altimmune adds Lonza as a manufacturing partner for supply of AdCOVID, its single-dose intranasal vaccine candidate for COVID-19.
  • News Ingredients and Formulation - evolving opportunities and challenges

    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.
  • News Ingredients and Formulation - evolving opportunities and challenges

    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.
  • News Technical article: Particle engineering approaches for dry powder inhalers

    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.
  • News On-demand webinar: Engineering approaches to respiratory drug delivery: Mannitol case study

    Both spray drying and jet milling are commercially viable engineering processes for the development of respirable drug products.
    This case study explores the material and performance properties of mannitol, spray-dried and jet-milled, for respiratory delivery. The head to head comparison reveals opportunities and risks for designing a product based on each approach.
  • News On-demand webinar: Technical considerations for capsule-based inhalation product development

    Drug delivery to the lung is an important and growing field of research for both local and systemic treatments. Efficient nasal and pulmonary drug delivery requires precise particle size and density control.
    Lonza Pharma & Biotech has premier particle engineering capabilities with which to meet the exacting formulation requirements for dry powder inhaler (DPI) applications, utilizing both spray drying and particle size reduction technologies. These capabilities extend to the ability to control particle properties to interact positively with both capsule and delivery devices, making Lonza a preferred service partner for DPI products.
  • News Inhalation formulation services with premier particle engineering platform

    Lonza Pharma & Biotech provides integrated DPI (dry powder inhaler) development services to advance molecules, drawing on 25 years of experience in particle engineering, formulation design, and encapsulation techniques.
    Our premier particle engineering technologies services, utilizing both jet milling and spray drying, are tailored to your molecule, target product profile and delivery device. Dedicated DPI formulation, analytical and manufacturing teams ensure that development timelines are met while minimizing program risk and complexity.
  • News Lonza enhances product line to tackle concerns around bias during blinded clinical trials

    The cost-effective capsules incorporate anti-tampering measures to ensure they comply with blinding regulations.
  • News Lonza’s Ibex solutions to support Genmab’s growing clinical portfolio

    Company's Ibex Design planned to take Genmab’s pre-clinical candidates from gene to potential IND within 12 months.