Additional capacity is needed to support growing demand in the clinical and commercial manufacture of complex biologic drug products, such as antibody-drug conjugates (ADCs),
as well as prefilled syringes in metabolic diseases and autoimmune disorders.
 
Lonza recently completed the expansion of its new drug product services facility in Basel Switzerland, adding a new facility for quality control and bioanalytics to support early and late-stage clinical and commercial drug product (DP) quality control (QC). The new facility allows DPS to double its capacity for the development and testing of parenteral dosage forms.
 
Peter Droc, Head of Drug Product Services at Lonza discusses how the new DP facility helps ensure products are safe, effective and meet regulatory requirements, along with key trends and challenges in biologics manufacturing today and the motivating factors for clients to outsource. 
 
Contract Pharma: How does Lonza’s new DPS site in Basel help ensure products are safe, effective and meet regulatory requirements?
 
Peter Droc: The new facility, expanding our capacity for quality control (QC) for biologics drug products, has recently received Swissmedic approval for GMP manufacturing. This license confirms that the quality controls meet regulatory standards. 
 
The Basel facility also offers the capability to develop and perform analytical testing for highly potent biologics, including antibody-drug conjugates (ADCs) – a therapeutic modality realizing its potential in oncology and holding promises in other therapeutic areas. To meet the unique needs for these therapies, we built a highly contained room equipped with HEPA filters, enabling the reconstitution of highly potent lyophilized products and handling highly potent powders. Powered by our team of experts, the facility also supports full in-house testing with cutting-edge technologies such as innovative particle investigations, affinity binding and cell-based assays, all located in adjacent buildings to increase speed and efficiency.  
  
Contract Pharma: What are some key trends and challenges in biologics manufacturing today?
 
Peter Droc: We continue to see several trends shaping the biologics manufacturing landscape. This includes manufacturing demand outpacing supply, especially for large-scale manufacturing. This is largely driven by an increasing number of emerging and complex modalities such as ADCs joining the development pipeline, and a growing need for more patient-friendly treatment options like prefilled syringes. Lonza continues to evolve and adapt to these global trends through increased investments in facilities and technologies.  

To strengthen our drug product network, we have invested CHF ≈ 500 million into a large-scale manufacturing facility with capabilities for biologics filling into prefilled syringes (PFS) and vials – as liquids or lyophilized products. This expansion complements our recent acquisition of the large-scale biologics mammalian manufacturing site in Vacaville, CA from Roche. This network expansion strategy strengthens our integrated offerings for our customers by simplifying their supply chains and offering them the agility they need to promptly react to the changing market supply needs.  
 
We are also enhancing our end-to-end offerings for ADCs to meet patient and industry demands. We continue to see a strong demand for outsourcing in the highly potent ADC space and continue to adapt to these evolving trends. We are currently finalizing the implementation of a highly contained vial filling line at our Stein site in Switzerland, bringing the capability to fill ADC into vials and subsequent lyophilization. Through this expanded offering, drug developers can benefit from an end-to-end integrated drug substance and drug product manufacturing offering along the product lifecycle, which also includes a unique bioconjugation toolbox with tailored solutions for developing ADCs.   
 
In addition, the increased prevalence of chronic diseases like metabolic diseases and autoimmune disorders is increasing the demand for more treatment options that improve patient adherence. This includes PFS that can be administered in the convenience of patients’ homes. We continue to expand in the end-to-end PFS space through comprehensive development services. For example, we have recently implemented a PFS preclinical manufacturing line that allows to accelerate the path to clinics, as well as our commercial-scale GMP manufacturing. 
 
Contract Pharma: What services are clients seeking out in Lonza’s recent manufacturing collaborations and what are the motivating factors for clients to outsource?
 
Peter Droc: Drug developers are seeking support in several areas. Firstly, they are looking to simplify their supply chain. Biotechs need to have access to a streamlined manufacturing process across all development stages and dosage forms. This translates into a growing demand for an end-to-end integrated drug substance and drug product programs. Lonza offers these solutions, spanning from early development to commercial manufacturing across both biologics drug substance and drug product and across a wide range of biologic modalities: mAbs, bispecifics, microbial-derived proteins and ADCs, as well as most biologics dosage forms: liquid or lyo products in vials and PFS.  
 
As an example, we recently announced an extension of our collaboration with Acumen to manufacture cGMP drug product of the company’s monoclonal antibody, sabirnetug (ACU193), for ongoing and future clinical phases and support the potential commercial launch. This builds upon our initial agreement earlier this year to provide mammalian drug substance manufacture for Phase 2 clinical supply. This collaboration is an example of how we can integrate our drug substance and drug product manufacture programs for drug developers and advance their innovative therapies with flexibility, speed and a simplified supply chain. 
 
Our customers are also looking for agility to respond to changing market needs. To respond to the evolving needs along our customer’s products’ lifecycle, we continue to invest in various scales and capacity expansions and focus on continuously developing our experts.