Small-Molecule Businesses

Drug candidates based on chemical technologies in the development pipeline are increasingly innovative and often highly potent specialty medicines. They enable drastically improved treatment opportunities for patients in need. Fast-track regulatory approval programs have been introduced to meet these needs by shortening the time to market and compressing timelines for the developer. At the same time, the increased potency can lead to challenges in development and manufacturing, including the need for specialized handling in high containment systems. As these molecules are often poorly soluble, expertise in formulation is also required to increase bio-availabilty. Lonza is uniquely positioned to provide solutions to these challenges.

Integrated Offerings in Pharma & Biotech – Chemical Technologies
Integrated Offerings in Pharma & Biotech – Chemical Technologies (graphic)

Drug Substance Development and Manufacturing

Lonza has one of the widest breadths of expertise in the production of highly potent active pharmaceutical ingredients (HPAPIs) within the contract manufacturing organization industry. This expertise spans highly skilled teams, state-of-the-art facilities and approximately 20 years of experience in successfully commercializing HPAPI products and full scalability allowing our customers to use clinical-phase appropriate manufacturing scales. For the production of other APIs, Lonza’s breadth and economy of scale, our many years of experience in launch and long-term manufacture, and the dedication of our personnel ensure that we remain a leader in small-molecule contract manufacturing.

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clinical small-molecule programs

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commercial small-molecule programs

(including dosage form and delivery systems)

The small-molecule team is heavily involved in the development of therapies designated by the U.S. Food and Drug Administration (FDA) as breakthrough therapies. Accelerated time-to-market is a key factor in their development and production. Lonza has driven processes to ensure APIs are delivered to the accelerated timelines to support these launches.

With the 2017 transformational acquisition of Capsugel and the bolt-on acquisition of Micro-Macinazione, Monteggio (CH) the small-molecule businesses further extended our offerings for development and manufacturing of highly potent active pharmaceutical ingredients (HPAPIs). Lonza now has a fully established value chain for highly potent products from the active pharmaceutical ingredients (API) through particle engineering into the final dosage forms. This broad offering adds substantial value to our customers as it simplifies interfaces, reduces costs and accelerates timelines.

Drug Product Development and Manufacturing

The newly acquired drug formulation development capabilities from Capsugel aim to overcome our customers’ key challenges of complexity, bioavailability, solubility and high potency, while helping shorten lead times for drug launches. As the majority of the products in clinical development pipelines have poor solubility, we are addressing that market need with our broad toolkit for bio-availability enhancement, our expertise in APIs and modulating pharmacokinetics, and our capability in handling highly potent materials and dosage-form expertise to support modulated release.

Laboratory staff checking a purple liquid (mood picture)

The addition of Micro-Macinazione to the Lonza portfolio has extended our small-molecule offerings into particle engineering that facilitates the conversion of APIs to the finished dosage forms. By adding Capsugel, a world leader in enhanced oral dosage delivery technologies with a market-leading position in hard capsules, Lonza has created a powerful all-round player, from drug substance and formulation expertise to final dosage form.

Pharma Hard Capsules

The hard-capsule business continues to build on a long track record of ingenuity, credibility and flexibility to deliver an exemplary experience and drive added value creation for our customers. Proprietary and patent-protected technologies, unrivaled expertise in capsule polymer science, and product and process design capabilities all help customers meet their target product profiles and commercial objectives while allowing rapid design and development across a wide range of dosage forms.

Leveraging extensive experience in capsule delivery solutions, Lonza also offers an unmatched value-added service portfolio with a global quality organization, which includes an integrated supply chain, technical and operational engineers, color lab support and global regulatory expertise. Continuing a commitment to delivering high-quality products and maintaining the highest standard of regulatory compliance, the hard-capsule business has established standards and systems to oversee internal and external quality performance, which is known industry wide.

Capitalizing on the vast global network built by Lonza and Capsugel, coupled with the unmatched science and engineering behind the hard-capsule business, Lonza can provide a broad range of capsule polymers, sizes and designs for the industry. We also have the ability to offer integrated product design, development, clinical supply and commercial manufacturing services to our customers around the world. The diversified customer base includes companies that make branded, generic and specialty pharmaceuticals, as well as biotech products and over-the-counter medicines.

Discover More

For further information about our offerings in small molecules, including our expertise in HPAPI and other active pharmaceutical ingredients, visit our website. Click here for a 360° Virtual Tour of our facilities in Visp (CH) and Nansha (CN). Visit our Capsugel and Micro-Macinazione websites.

Highlights and Initiatives 2018

Throughout the year our small-molecule businesses – including capsule and combined ingredient and dosage-form offerings – continued to perform strongly. Lonza Pharma & Biotech’s small-molecule businesses reported continued operational and commercial improvements. Demand for Lonza’s offerings in API development and clinical and commercial manufacturing held firm. Pharma hard capsules and dosage form and delivery systems performed above expectations as a result of buoyant customer interest and the capture of cross-selling synergies.

Drug Substance Development and Manufacturing

Group of people opening a facility in Visp (CH) by cutting the red ribbon. (photo)

Lonza expanded HPAPI manufacturing at our Visp (CH) plant when Lonza and Clovis Oncology celebrated the opening of a new, dedicated production train for Rubraca® (rucaparib), Clovis’s U.S.- and EU-approved drug for several ovarian cancer indications. The innovative operating model and technology deployed reduce production lead time and costs. Under a long-term agreement, the new, state-of-the-art monoplant enables security of supply and flexibility to ensure a rapid response to changes in market demand for Rubraca®.

« Our partnership with Lonza and the opening of this dedicated facility in Visp (CH) should allow the continued availability of Rubraca® to patients who may benefit from its use, now and in the future »

Patrick Mahaffy, CEO and President of Clovis Oncology

Lonza added two new manufacturing suites at the Visp site for the manufacture of antibody drug conjugate (ADC) payloads, based on a tailored business agreement with a major biopharmaceutical partner. The new suites enable handling of a variety of highly potent products with occupational exposure levels down to 1ng/m3 and thereby strengthen the overall bioconjugation capabilities of Lonza in Visp.

Lonza announced the launch of our pharmaceutical early-intermediates supply initiative. The initiative leverages chemical production facilities at the Visp site to address increasing global early-intermediates supply security and quality concerns. Lonza now offers customers an integrated supply chain from non-GMP early intermediates to current good manufacturing practice (cGMP) advanced intermediates and APIs.

Drug Product Development and Manufacturing

During 2018 Lonza completed the integration of the Capsugel businesses, and the addition of Capsugel further strengthened the depth and breadth of Lonza’s offerings for small molecules. It expanded the reach of Lonza’s contract development and manufacturing organization (CDMO) and products businesses and further growth is expected in the years ahead, not least through the synergies the acquisition has unleashed.

Our oral drug product services added to the positive year 2018 by securing several projects with new and existing customers and by strengthening the overall portfolio. Firm demand continued for dosage forms and for delivery solutions and services to enhance bioavailability and efficacy of drugs.

First synergistic projects have been captured that either leverage Lonza’s network to extend the value chain or that cross-sell to customers. Innovation projects are ongoing and deal with continuous manufacturing and automation, bioavailability and efficacy enhancements through the introduction of new formulations, modulated-release mechanisms and new approaches to the manufacturing of high-potency substances.

In February we announced the expansion of our late-stage clinical and commercial encapsulation capabilities for solid oral and inhaled dosage forms in North America, with the installation of a new encapsulation unit at our integrated product development and manufacturing facility in Tampa, FL (USA). The added capacity will further strengthen our speed-to-market capabilities. This specialized drum-dosing technology is used for powder-in-capsule (PIC) filling for oral solid dosage forms including dry powder inhaler (DPI) applications.

Pharma Hard Capsules

The hard-capsule business reported a robust year 2018 and saw increasing demand for Lonza’s specialty polymer capsules by pharmaceutical companies to enhance bioavailability and to provide a wider choice for customers. Geographic expansion programs, expansions across the sites and operational excellence programs have been implemented and are ongoing to strengthen the business’s global presence to meet customer demand.

Lonza Small Molecules’ Global Footprint and Investments
Lonza Chemicals’ Global Footprint and Investments - world map (graphic)

From early-stage development to commercial solutions, the hard-capsule business continues to offer the broadest portfolio of gelatin and Hydroxypropylmethylcellulose (HPMC) capsules. In August Capsugel® Colorista capsules – a high-quality capsule based on an «all-colorants» formulation – was launched. It is a new single research & development solution for pharmaceutical formulation development that cuts development time and allows for flexibility with testing. This new capsule further expands the Lonza Capsugel® clinical offering.