Designing the Way to Manufacture the Medicines of Tomorrow

Lonza, that produces Corona's vaccines for Moderna, is enabling its customers to deliver innovative medicines by supporting the entire lifecycle of their molecule - from late discovery through market supply. In an interview with Abdelaziz Toumi, Head of EMEA Biologics Sales in Lonza, he points out the challenges of the industry and offers his advice to small biotech companies that are looking to take their therapeutic candidates to the clinic

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Lonza Biologics Development LabCredit: Lonza
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Lonza Biologics is the world-class, full-service, contract development and manufacturing organization that supports start-up biotechs to big pharma, from late discovery through market supply. Operating across nine global sites, three continents and a spectrum of scales from 1kL up to 20kL, including single-use and stainless-steel bioreactors, the company offers expression technologies and services for mammalian and microbial derived molecules, bioconjugates as well as mRNAs. Its services cover both drug substance and drug product and support the entire lifecycle of a molecule.

"The cornerstone of our ability to establish strong partnership with customers is our 30+ years of unmatched experience, the comprehensive resources, and global network that we bring to each project", says Abdelaziz Toumi, Head of EMEA Biologics Sales in Lonza in an interview to "BIOTECH" magazine. "Our customers benefit from our deep expertise, deft execution, proactive issue resolution, leading technologies, comprehensive services and uncompromising quality. In designing the way to manufacture the medicines of tomorrow, we continuously invest in advanced technologies, innovative offerings and robust infrastructure, to meet our customers’ ever evolving needs".

What has changed in the biopharmaceutical industry in the last decade?

"Over the past decade, the biopharmaceutical industry has observed a drastic change in the traditional drug discovery and development model. As larger companies undertook significant endeavors to streamline their business models and refocus their R&D efforts, many small biotechs have stepped up to shoulder the drug discovery and development process.

 "In the COVID race to vaccine, we have seen many small biotechs at the forefront of innovation. To do so, those companies need to partner with organizations that can support them with expertise and manufacturing capacity, but that are also willing to share the risks associated with high clinical attrition.

"The COVID-19 pandemic has also helped accelerate the adoption of new technologies such as mRNA", Toumi continues. "On 1 May 2020, Lonza and Moderna announced a worldwide collaboration to enable the manufacturing of up to 1 billion doses per year of Moderna’s vaccine candidate (mRNA-1273) against the novel coronavirus.

"Additionally, cell and gene technologies are seen as the new frontier in medicine. The manufacture of such medicines brings new challenges for affordable curative medicines to patients globally. Lonza's Cocoon provides industry and medical centers, the efficient manufacturing solution for affordable and scalable personalized cell therapy to treat critically ill patients.

Abdelaziz Toumi Credit: Maayan Sela

"Finally, the Israeli growing biotech community, with its expertise, innovation and knowhow, has become a very attractive market and a key customer base for Lonza".

From standard antibody formats to next-generation biologics

what trends are you seeing in the biologic pipeline? 

 "As market demand continues to rise for more potent and effective therapeutics, biologic pipelines are evolving from standard antibody formats to next-generation biologics such as dual-targeted bi-specific antibodies. With new molecule classes and more variations in functional structures, there are many unknowns to determine in the development process and the risks of failure are higher than ever.

"New challenges are also brought by accelerated approval pathways such as FastTrack and Priority Review, which have increased pressure to quickly deliver therapies to the patients who need them most".

What are some of the most pressing challenges the smaller biotechs face?

"One of the biggest hurdles facing small biotech companies is to efficiently and successfully transition their lead therapeutic candidate to the clinic. By not taking a long-term view and understanding a molecule’s manufacturability early, companies face a multitude of costly risks. The largest of these downfalls include a loss of investor trust and funding, later-than-planned regulatory approval, and potentially decreased relevance in a crowded marketplace. Therefore, we suggest that a company should look for a partner company with reliable integrated drug substance and drug product development and manufacturing capabilities and a solid track record".

What is the biggest piece of advice that you would give to small biotech companies that are looking to take their therapeutic candidates to the clinic?

"Taking your promising molecule through the drug development journey is an exciting process. It’s natural to want to speed up your timeline and get it into the clinic as fast as possible. But cutting corners could eventually compromise the quality of your product as well as your regulatory success and obviously time to market.

a) De-risk your drug candidate

Only focusing on speed may lead some biotherapeutic developers to forego early de-risking strategies that, if considered, could prevent wasted time and money working on non-viable candidates. Worse, product and manufacturing process-related failures from these approaches could affect manufacturability and future funding. By utilizing a variety of early development assessment tools, you can significantly de-risk biologic products before spending significant time and resources on advancing the development of your candidate molecule. The more data and information you can generate early, the better chance you have of selecting only the most promising molecules, optimizing the ones that require it, and eliminating those with the highest risk profiles. Whether you have the in-house resources to do it on your own or you work with an experienced partner, performing even just one of these assessments adds value to your development process and reduces the chance of costly setbacks. And in the race to the clinic, these benefits serve as key advantages that can help increase the value of your asset while simultaneously developing products with the highest level of safety and efficacy.

b) Chose a cell line with commercialization in mind

Choose a cell line that is supported by robust & scalable manufacturing process for your molecule, has a strong track record in reliably delivering manufacture of products and has repeatedly demonstrated success. In addition, match your molecule to the right development platform: creating cell lines with speed, efficiency, and manufacturability is critical to your success.

c) Avoid overcomplicated development and manufacturing Plans

As a small biotech, you likely have limited inhouse expertise and will need outside experts to move forward in your drug development journey. It may be tempting to try to incorporate the assistance of several different companies, but that can just make your journey more complicated.

Consolidating everything under one roof is easier to negotiate up front, easier to manage over time and takes you faster to your next clinical milestone.

Choose a partner with reliable integrated drug substance and drug product development and manufacturing capabilities and a solid track record. So that it can support you holistically and together with you create a development strategy with the end point in mind.

Compared to outsourcing work to several companies, working with just one is likely to shave several months off your timeline, as well as save on costs.

d) Take steps now to ensure manufacturing capacity later

At the early stages of any drug development journey, product demand is largely unknown. This makes it difficult to predict product requirements.

The key consideration here for small biotech is look for a partner company with flexibility, one that has a business model that allows them to easily and quickly meet changing manufacturing needs and one that has the global manufacturing network to manage their products’ life cycle needs.

Small biopharma companies need assurance that they have access to capacity as their products progress through clinical stages. If they suddenly have good clinical results, but they don’t have access to manufacturing capacity, they’ll be sitting on a good molecule and won’t be able to progress as fast as they want".

Access to various program approaches and business models

Given all of the complexities that we have already touched on, what are the different approaches you’re taking to give your customers what they need?

"At Lonza, we offer customized solutions and services designed to meet our customers’ unique gene-to-IND needs. You’ll be assured a solution that matches your needs in terms of molecule types, timelines, yield optimization and risk. Regardless of molecule type, you’ll go from gene to IND using an approach—IBEX® Design, Light Path, or Full Scope—built specifically to support your goals. You’ll commence clinical trials as fast as technically possible, and you’ll have complete support to overcome any issues you may encounter on the way.

"If you are developing an antibody or an antibody like molecule and speed is your key priority, then we will recommend our pioneering Ibex® Design program that guarantees:

, 9 months from gene to tox drug product

, 12 months from gene to IND program with submission-ready CMC data for your IND/IMPD

, 1,5 kg GMP drug substance for your phase 1 clinical trials

"By working with Lonza, you will get access to various program approaches and business models that can be customized to meet your company’s and your investors’ expectations and maximize your asset’s value so you can move to the next milestone and round of funding".

Can you give us a specific example of a customized program approach designed to meet customer’s specific needs?

"Last week we announced our collaboration with Immunitas Therapeutics to rapidly advance their lead drug candidate to the clinic using a customized accelerated version of Lonza’s Ibex® design program. As part of the customized agreement with Immunitas, Lonza has tailored The Ibex® Design Program to provide rapid access to material for GLP toxicology and cGMP manufacturing for Phase 1 clinical study start. Lonza will carry out complete CMC development, drug substance and drug product manufacturing, enabling a rapid timeline from candidate selection to phase 1 study start".