With demand for small-molecule solutions to treat asthma, chronic obstructive pulmonary disease (COPD), and other respiratory conditions, Lonza is adding inhalation product capabilities at its site in Tampa, Florida. The expansion reportedly will boost the company’s capacity for dry powder inhaler (DPI) product development services.
To find out more about the expansion and the market trends driving the move, Outsourcing-Pharma spoke with Responses from Jeff Williamson, Lonza’s director of product development for small molecules.
OSP: Could you please share some perspective about shifts in recent years regarding the demand for inhalable therapies, especially DPI products?
JW: The rising number of monoclonal antibody DPI therapies is an interesting shift in the past few years, driven by the pandemic. Specifically, Lonza has observed that 30-50% of active pharmaceutical ingredients (APIs) intended for inhalable products are biotherapeutics.
DPIs can provide improved treatment options due to reduced dose and systemic side effects, avoidance of cold-chain storage requirements, and the possibility of simple, at-home administration. These are a huge improvement compared to injectables which are invasive, sometimes require cold-chain storage, and are likely administered by a trained professional.
DPIs, by design, are ideal to provide a localized treatment to combat cancer, asthma, chronic obstructive pulmonary disease (COPD), and other lung diseases by isolating the dose directly to the affected area. This type of delivery system is often preferred by the patient and their physician, due to its ease of use and product stability at ambient conditions.
Compared to small molecules, biotherapeutics are fairly delicate and require special formulation and manufacturing considerations to enable use as a DPI. This is why choosing the right manufacturing partner with the appropriate expertise is critical. I look forward to bringing solutions and being a part of the evolution of these monoclonal antibody DPI therapies at our newly expanded facilities in Tampa.
OSP: How has Lonza changed and grown to keep up with the demand up until this point?
JW: In relation to the increase of biotherapeutics for inhaled therapies, Lonza’s expertise in spray drying of monoclonal antibodies and other biologics for DPI can help realize these benefits for a different class of actives. Our inhalation team recently published a white paper that demonstrated a respirable, bioactive spray-dried powder containing bevacizumab (a treatment for non-small cell lung cancer) with 12-month stability at 25º C. In a follow-up study, the authors combined this formulation into a single dry powder with cancer-relevant small molecules.
In terms of manufacturing, we are continuously evaluating our facilities to ensure we have the capabilities and expertise to provide our partners with integrated end-to-end services for their respiratory drugs. Recently, we expanded our Tampa site to include an additional inhalation testing capacity and extend our services in this area. The new laboratory suite will focus on method development and quality control testing to support product development, clinical, and commercial manufacturing of DPIs.
OSP: Are there any special features or capabilities at the expanded Tampa site you would like to highlight?
JW: As a growing number of our client portfolios are in the early stages of development, it’s important that we have the capacity to support our partners from step one all the way to commercial manufacture. The focus of our extension is to drive efficiency and project delivery for feasibility and early-stage clinical studies. The new area will be equipped with essential and advanced-level analytical equipment and containment systems for highly potent active pharmaceutical ingredients (HPAPIs) to provide specialized performance testing, including aerosolized particle size analysis (APSD) and delivered dose uniformity (DDU).
Currently, our Tampa facilities provide a full suite of development and manufacturing services inclusive of clinical packaging, labeling, serialization, and distribution. We specialize in non-GMP development and phase I-III cGMP manufacturing for oral solid dosage forms and inhalation products. Historically, we have primarily supported the development of immediate-release and modified-release tablets and capsules. We have evolved in developing and supporting inhalation products, this new laboratory will provide the analytical component to complete the extension of service.
OSP: What about new products you’re working on to complement your current capabilities around DPI products—is there anything you can share in that area?
JW: Most recently, my colleagues Kimberly Shepard, Maureen Kadleck, and David Vodak recently published their insights in a paper about simultaneous spray drying for combination DPI formulations. These combination therapies involve both small molecules and biologic elements designed and delivered by DPI.
These combinations are of particular interest for improving patient experience and compliance while managing complex lung conditions such as non-small cell lung cancer. As I previously mentioned, this is a rising trend that we’ve observed in the last couple of years. Our inhalation experts continue to provide cutting-edge technologies to solve complex problems such as this.
OSP: Do you have anything else you’d like to add?
JW: Lonza’s inhalation experts work with our customers from designing and developing particle-engineered formulations all the way to commercial manufacture. Our aim is to provide them with end-to-end integrated services to help meet accelerated timelines that can be critical in meeting first-in-human clinical trial requirements, as well as reducing cost- and time-inefficiencies.
We continue to evaluate and evolve based on our customer’s needs, with the ultimate goal of getting these products to patients to improve their quality of life.
