Switzerland-based Lonza has increased its solid-form selection services offered at its Bend, Oregon site. The expansion is designed to help complement its SimpliFiH Solutions services, which include phase-appropriate drug substance, product development and manufacture.
Michael Grass, head of solid form services for Lonza pharma and Biotech Small Molecules, spoke with Outsourcing-Pharma about the reasons for the expansion and what they might mean for potential customers.
OSP: Could you please share an overview of your SimpliFiH solutions—what offerings are under that umbrella?
MG: Lonza’s SimpliFiH Solutions is an integrated drug substance and drug product service offering aimed at rapid advancement of molecules – especially those with solubility or dissolution rate challenges – to phase I trials. This service package taps into Lonza’s global network of sites to seamlessly bring phase-appropriate drug substance and drug product components to small and virtual biopharma companies that rely on service partners to advance their molecules.
The services are designed to be flexible to meet specific drug program needs across API manufacturing and drug substance supply, solid form characterization, particle engineering – including spray-dried dispersion and micronization – and phase-appropriate drug product in powder-in-capsule, powder-in-bottle, or tablet format. Regulatory services are included in the package as are clinical supply services covering all aspects of logistics and returns.
We have recently announced expansions of early-phase manufacturing capabilities at our Tampa and Bend sites. We have also expanded our solid form services covering salt, polymorph and co-crystal selection services in addition to drug substance characterization.
OSP: What are some of the challenges that companies have faced in early-stage molecule development?
MG: Recent challenges that are being faced in early-stage molecule development include the facts that:
- more than 70% of molecules in biopharma pipelines are bioavailability challenged due to poor solubility
- much of the small molecule pipeline is being advanced by small biopharma companies that lack physical assets for manufacture and characterization of drug substance and drug product and
- many of the molecules are being progressed under rapid review designations greatly compressing the development timelines.
Limited funding for a number of start-up companies with molecules is an additional challenge and one that makes it especially important to reach early phase milestones rapidly.
OSP: What distinguishes the service offerings from Lonza from similar solutions promised by other companies?
MG: The key differentiator for SimpliFi Solutions is its foundations in bioavailability enhancement expertise, potent and highly potent drug substance manufacture and integrated drug substance and drug product services not only for phase I, but with line of sight to commercialization.
Solid form service offerings are well-established and often indistinguishable from one other. Most of the industry solid form offerings are stand-alone. The differentiating feature that Lonza is offering is the tight connection between the solid form selection/optimization and the drug substance process upstream of form selection and the downstream drug product manufacturing process.
OSP: What are the key ways in which the solid-form services offered via your Bend facility help customers overcome those challenges?
MG: The rapid pace that characterizes many drug development processes these days mandates that the programs are optimized for timing. While the Lonza solid form services may not be differentiated from competitors on its own, solid form selection is a critical part of any drug development program.
By having an integrated drug substance to drug product service that is combined with bioavailability enhancment technology selection and solid form selection, Lonza is capable of shortening the Phase I drug development process by several months.
OSP: Could you share some of the reasons why it makes sense to situate these expanded solutions at your Bend facility?
MG: Our solid forms services offering is centered at Bend since the preponderance of molecules that need to have their solid form optimized are also poorly soluble and bioavailable. This allows a very close connection from our solid form services offering and our amorphous solid dispersion offering, also based in Bend.
That said, there is integrated collaboration between our Bend site and our drug substance sites in Nansha, CN and Visp, CH, as well as our drug product site in Tampa, FL. This ensures that the preferred solid form determined by the Bend team is also one that can lead to an optimized solid form produced from the drug substance manufacturing process.
OSP: Is there anything else you’d like to add about your solid-form services, other capabilities available at Bend, other announcements you might like to preview to OSP readers, etc?
MG: As noted earlier, recent highlights from Lonza include expansion of our SimpliFiH® Solutions integrated first-in-human service offering which allows biopharma to have a single source for drug substance to drug product for early phase clinical trials. The expansion includes early phase drug substance synthesis, our newly launched solid form selection services, technology selection for poorly soluble molecules, all of which tie to our drug product services; these services include powder-in-capsule, powder-in-bottle or tableting.
In addition, we recently announced a significant investment dedicated to early-phase product development and GMP manufacturing of enhanced oral solid dosage forms to enhance agile, early-phase clinical program support where both operational flexibility and problem-solving must be balanced with quality and reliability.
Coupled with these expansions is our work ‘behind the scenes’ to ensure that our site network operates as a single entity. All CDMOs offering integrated services across drug substance and drug product are made up of formerly independent companies with their own approach to project management, quality systems, data management, etc.; Lonza is no different and we have multiple ongoing initiatives to integrate our site network into a seamless operation that can meet accelerated project timelines.
We also continue to expand our integrated service offer for antibody drug conjugates (ADCs). ADCs are a growing class of biopharmaceutical drugs designed as an effective targeted therapy for treating cancer and consisting of a highly selective monoclonal antibody, a HPAPI or payload for killing the tumor cell, and a linker. Lonza has invested heavily to ensure that all ADC elements are available under a single quality system at our Visp (CH) site.
Recent investments include new 4 cubic meter multi-production lines for HPAPI, a dedicated ADC payload facility for bench scale through to 10 cubic meter production – with containment to 1 ng / cubic meter – and an expanded bioconjugation facility for development through commercial scale capacity.