It likely is safe to say no professionals in drug development and manufacturing has a reliable crystal ball that can provide a crystal-clear picture of exactly what will happen in the coming 12 months. However, seasoned and savvy professionals can offer educated opinions, and advice on preparing for what might lie ahead.
To get a clearer perspective on what 2021 might have in store for the pharma field, Outsourcing-Pharma (OSP) checked in with three Lonza executives, asking their thoughts on 2020 as well as the new year:
- Christian Dowdeswell (CD), vice president and global head of commercial development for the company’s small-molecules business
- Charles Christy (CC), head of commercial solutions for Ibex Dedicate
- Anne Holderbach (AH), head of regional marketing for capsules and health ingredients
OSP: Could you please share an overview of Lonza’s year in 2020?
CD: In response to continued strong demand for highly potent API (HPAPI) manufacturing, in 2020, we continued to focus on these capabilities, including opening an asset capable of handling cytotoxic payloads for antibody-drug-conjugate (ADC) products and two HPAPI manufacturing lines at 4500L scale.
Since many of our customers are looking for integrated API and drug product services, they appreciated our new solid form chemistry services offering. As part of our commitment to our customers in the early phase, we have announced capital expansions of early phase manufacturing in Bend, Oregon (US), totaling 11 development and manufacturing suites, with one line coming online in 2020.
We also increased HPAPI handling capability focused on early phase in Tampa (US) for the drug product, and increased HPAPI development and clinical manufacturing capability being announced for our Nansha (CN) API facility.
CC: We have seen strong growth in our novel business offerings that have been developed to support the challenges of our customers within biologics. The pharma industry has to deal with considerable risk in development, with uncertain outcomes, especially in terms of demand and speed to market and patient.
Our Ibex Design gene to vial offering for mAbs has been particularly attractive to small and emerging biotechs where they appreciate the guaranteed offering (time, budget and quantities delivered) as well as the simplification of the supply chain (combined drug substance and drug product offering). Our Ibex Dedicate offering has been instrumental in overcoming significant challenges for our customers’ major projects supporting such customers as Sanofi, Moderna, Kodiak Sciences and Servier, while offering novel solutions to risk management, including capacity sharing/re-purposing via Lonza, significantly mitigating clinical or commercial risks.
AH: We continue to see strong demand for our products across all markets, as consumers and patients alike take a more active interest in their health. To meet this growing demand, in October, Lonza announced a CHF85m ($93m USD) investment to expand its overall production capacity of capsules within the Capsugel portfolio by 30b capsules annually while maintaining the high-quality standards with Lonza's Sigma Series.
Production capacity will be increased across Lonza's global manufacturing and supply chain network to help further strengthen the company's position as a leading global supplier of capsules. The investment will allow a 15% increase in CHI's current capsule production capacity.
OSP: How has the drug development field evolved over the past 12 months?
CD: HPAPI manufacturing and product development continue to be key business drivers for the small molecule business. As molecules in the drug pipeline grow more complex – for example, linker chemistry for ADC products, dendrimer molecules – being able to handle challenging API chemistry will become more important.
Patient-centric dosage forms have driven both innovation, investment, and pipeline growth for specialized delivery technologies. These include multi-particulate dosage forms for pediatric delivery and engineered dry powder dosage forms for inhalation delivery.
CC: We have seen significant trends to increased speed. Many novel biotherapeutics are on accelerated or breakthrough designation regulatory pathways; this means that they are progressing at unprecedented speed towards approval.
Lonza has become a vital partner for such companies, offering flexible capacity and processes developed from the outset that are optimized for commercial production (designed for the lifecycle of the product providing robust, scalable processes with the optimal cost of goods using platforms that simplify regulatory approval).
Finally, we have seen COVID19 projects moving at “warp speed” to combat this pandemic. Our GS cell line has facilitated rapid production (University of Queensland) and our Ibex Dedicate model has enabled Moderna to move to commercial scale production of 100’s of millions of doses per year in under 8 months with commercial production already occurring in December 2020 from our sites in Portsmouth USA and Visp Switzerland.
AH: Similar to our colleagues in the small molecule and biologics space, there has been an increase in speed to market for many APIs. Additionally, the growing trend of targeted therapy has driven the demand for specialized capsules designed for novel applications.
Whereas capsules were originally seen as mere simple containers for the fill material, the latest generations of capsules can now assist in further optimizing the delivery and performance of the API. Lonza, an industry leader and trusted partner, uses quality –by-design-principles, in depth science-based capsule knowledge, high performance manufacturing, a global supply chain, and a range of dedicated customer and product development services to meet the dynamics and complexity of the globalizing capsule market.
OSP: Can you share how the demands and concerns of your customers have changed over the past year?
CD: While speed during development remains a key demand from our customers, scalability towards a viable commercial manufacturing process was raised as an important topic, with speed in development not intended to compromise the ability to launch a product.
Clearly, 2020 has seen us adapt our business process in response to COVID-19. We increased the use of digital technology, implementing live streaming virtual tours and virtual audits, which we expect to continue even beyond the end of the pandemic.
CC: We see a continued trend in innovation and product development being driven, from academic institutes and small and emerging biotech companies. These companies need different support and business models than established pharma, ensuring investor concerns are taken into account.
A good example of this was our collaboration with Anthos Therapeutics, where we offered a highly unique and tailored program. The partnership utilizes Lonza’s novel milestone business model designed to support biotech companies and their investors by aligning deliverables, cash flow and value generation.
AH: Like our other Lonza division partners, speed to market remains a driving concern for our customers. However, in the past year, we do see a heightened focus on the supply chain and surge capacity to meet growing customer demands.
OSP: What types of industry trends have had the most impact on your ingredients and manufacturing business?
CD: Customers are increasingly looking for long-term capacity security ahead of launching new products. This goal is impacting the way we are structuring deals with customers. We are also continuing to see strong interest in and demand for HPAPI/complex molecule manufacturing, early-phase manufacturing and integrated API/drug product development services.
CC: We see a resurgence in ADCs for targeted treatment of cancer. We announced a major project at the beginning of December to support a pharma company commercializing two ADC products, as well as announcing expansions to our conjugation facilities serving this rapidly growing segment.
AH: In both the pharmaceutical and nutraceutical markets, a common trend is a need for pro-active solutions. This current industry trend leads to an increased demand for capsules in the pharmaceutical, where patients are seeking preventative treatments, as well as in the nutritional supplement market, where consumers are looking for products supporting a healthier lifestyles.
Another trend specific for the nutrition supplement market is the ‘clean label’ trend. Lonza offers a growing portfolio of products to meet consumers’ demand for organic and non-GMO sourced ingredients and supplements, including vegetarian/vegan capsules, TiO2 free capsules and natural-colored capsules.
OSP: Specifically, what therapeutic areas have impacted your operations, and how?
CD: Oncology, often requiring HPAPI capabilities, is the main therapeutic area driving the API development and manufacturing demand from our customers. In addition, the chemistry of small molecules in oncology often leads to low solubility, driving the need for bioavailability enhancement technologies.
Inhalation, while strictly a delivery technology rather than a therapeutic area, is an area that is showing rather marked growth in our particle engineering & drug product business, and we are making investments to support this growth.
CC: We see strong growth across all modalities. Cell and gene therapy is experiencing tremendous growth and we are preparing to commercialize multiple therapies, including viral vaccines for COVID-19.
Our microbial business also sees strong growth, with demand ranging from vaccines to novel products such as antibody fragments. Our mammalian business also sees sustained strong demand from both traditional mAb formats as well as new mAb formats (next-generation molecules such as bi-specifics, novel frameworks).
AH: As therapeutic formulations become more complex, such as dry powder inhalation dosing and oncology treatments, the requirement for unique dosing formats and technologies have increased to allow for HPAPI and targeted drug delivery. Lonza has a variety of products to meet targeted drug delivery needs, include the Capsugel Zephyr suite of DPI products and Capsugel Vcaps Plus, HPMC capsules with true pH and ionic media independence in disintegration providing an excellent alternative to gelatin or traditional HPMC capsules.
OSP: What are your customers looking for in the HPAPI realm, and how is Lonza striving to meet those needs and concerns?
CD: Customers are looking for additional HPAPI capacity and complex manufacturing/chemistry capabilities. Lonza will continue to invest in additional HPAPI development and manufacturing capacity throughout our global network. In 2020 we opened an asset capable of handling cytotoxic payloads for ADC products and two HPAPI manufacturing lines at a 4500L scale.
OSP: Shifting to a look forward: How do you think some of these changes and trends might carry into the new year?
CD: With oncology driving many of our customers’ pipelines, we expect the HPAPI and complex chemistry trends to continue for the foreseeable future. We also expect continued need for innovative patient-centric drug product technology to improve the effectiveness and compliance of patients in taking these important therapies.
The importance our customers adhere on securing development and manufacturing capacity is likely to drive longer-term capacity deals, both in development as well as for commercial manufacturing.
The use of digital technology is firmly embedded within many of our customers. Whilst we expect that a return to face-to-face meetings is desired and will come about in due course, we also anticipate that virtual meetings & tours will remain a feature of our business in the future.
CC: A focus will be on the preparedness for COVID-19 and future pandemics. The COVID-19 pandemic has stressed the importance of manufacturing and the availability of appropriate capacity, including human capital.
There will be a global focus on ensuring adequate capacity for therapies for emerging viral threats, including vaccines and antibody therapies. Lonza is rising to this challenge by increasing our global network with expansion in major new facilities in the USA (Hayward and Portsmouth), Switzerland (Basel and Visp), UK (Slough) and China (Guangzhou), amongst others.
AH: As patients and consumers adapt to live in a (post-)COVID-19 world, we see preventative treatment trends and the desire to support healthier lifestyles continuing. As pharmaceutical companies strive to provide innovative and patient-centric drug products, we see the need for unique dosage form solutions to grow.
At the same time, health supplements consumers savviness will drive nutritional supplement companies to provide an experience with their product, with innovative dosage forms such as capsule-in-capsule product, natural coloring and organic ingredients.
OSP: How has the COVID-19 pandemic impacted the industry, and do you see the virus continuing to impact drug development and manufacturing into the new year?
CC: COVID-19 has accelerated many developments, from the investment in capacity to the development of novel therapies. An example of this is the stunning developments in mRNA technology that holds the promise not only to combat COVID-19 but also to radically transform the treatment of infectious disease.
mRNA has delivered COVID-19 vaccine candidates in record time, with broad efficacy and tremendous ability to treat mass populations. mRNA can be a highly effective platform for the treatment of existing and future viral diseases.
Speed will also continue to be a factor, and once again, our Ibex Design gene to vial offering with a 12 month from gene to IND will continue to offer clients speed to the clinic without any compromise in quality or process robustness.