Evolving strategies for successfully developing biosimilars and non-platformed therapeutics

Interview with Hitto Kaufmann, VP, Process Science, Boehringer Ingelheim, Germany

Challenges of working with next-generation therapies

Next-generation therapies such as bi-specifics, fusion proteins and fragments offer tremendous benefits on paper, but it’s the bioprocessing departments that have to develop the new production methods, switch to new platforms and investigate new capture steps.

We caught up with Boehringer’s VP of Process Science Germany, Hitto Kaufmann to discuss such challenges in anticipation of his keynote presentation at this year’s Bio Process International Europe conference in Dusseldorf - Evolving strategies for successfully developing biosimilars and non-platformed therapeutics

Moving away from platforms

 “I see a couple of major trends. We see a lot more complex formats entering development: monoclonal antibody-derived formats such as bispecifics; other products that have partial structure features of the mAb, and totally new molecular formats that have no structural relationship to mAbs at all”, said Dr Kaufmann.

“There are probably over 20 mAb-derived product classes in development, but maybe only a few of them will succeed in clinic. As process developers we have to support all of them.”

“Mammalian production will move – to some extent - away from very strict, plug-and-play platform strategies to something that can be better described as a “toolbox” strategy. The industry will need to miniaturise more, do more experiments in parallel and invest in high-throughput analytical methods.”

Regardless of technological improvements, clinical performance will ultimately decide the winners and losers. “There are probably 20+ different product classes in development, but only a few of them will succeed in the clinic, maybe. However, as process developers we have to support all of them,” said Dr Kaufmann. “It’s a real challenge; the days when 90% of the leads were classic IgGs fitting a common platform are over.”

One thought is that CMOs and originators will work closer together to harness in-house knowledge. “We certainly see clients approaching us earlier to assess the CMC profile and to get a greater understanding of the process. Some discussions even happen during candidate selection which is a noticeable change. “

Biosimilar Manufacturing

In 2009 Boehringer announced that it would create a dedicated division for the development and commercialisation of biosimilars and industry observers are very interested in what the company has been up to, something Dr Kaufmann is keen to highlight in his talk.

“The biosimilar market brings significant challenges, most noticeably in bioprocessing. I think it’s safe to say that every company in the biosimilar space now appreciates that biosimilar manufacturing is very different to originator manufacturing. Everything needs to be looked at with a magnifying glass - any change, any scale up.

“For biosimilar development, you need to rapidly build up in-depth process knowledge, you want to control and understand everything. You need a much closer and broader exchange of ideas between process design and analytics; it is a very different set up compared to originator development,” Dr Kaufmann added.

“My presentation at this year’s BPI Europe conference will focus on Boehringer’s biosimilars experience from a technical and regulatory perspective, plus include new principles on process development – what we learnt, when to influence product quality and how departments interact. I will outline how the field is evolving and how it will evolve in the future,”

Dr Kaufmann’s keynote presentation on “Evolving Strategies for Successful Development of Biosimilar Manufacturing Processes” kicks off BioProcess International’s dedicated conference stream on biosimilar manufacturing on Wednesday 17 April. For more information please visit the website www.bip-eu.com.