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From the Editor: 5 Steps to Manufacturing Success for Early Stage Biotechs

Georgi Makin
9 July 2021

A recent interactive panel discussion explored a few key priority areas for early stage biotechs to consider in order to build a successful cell and gene therapy manufacturing pipeline. Here, I summarise key advice shared by the experts.

“Our goal today is, that whatever your role is in the industry or in your company, that you will come away with a new idea, a new perspective, a new strategy, that you can apply to be more successful in your business.” 

Over the course of the past year, the Covid-19 pandemic has had a huge impact on cell and gene therapy manufacturing capacities, as well as supply chain management.

Constraint and pressure applied by the urgent need to manufacture vaccines while managing an increasing demand for the manufacture of cell and gene therapy products may have led to a bias from CDMOs to favour addressing the demand from larger companies, but where does this leave early stage biotechs as they aim to progress their products through the commercialisation journey?

A recent Phacilitate panel discussion – produced in partnership with BioCentriq – sought to address some of the key priority areas for consideration by early stage biotechs in a post-pandemic world, featuring insights from Ryan Saadi (Tevogen Bio), Katie Kelleher (McKinsey & Company), Haro Hartounian (BioCentriq) and Peter Marks (FDA).

For my latest blog post, I explored a few key steps an early stage biotech can take to best position the company for success, based on the wealth of experience highlighted by the panel. 

1 – Identify partners early and exercise care when selecting a partner

“Find the right partners and leverage the experience that is already out there.”

A hot topic referred to a few times in different contexts was that early preparation is key at every stage, but Ryan Saadi stressed how important it was to Tevogen Bio to identify partners early in the process.

In fact, Ryan explained how Tevogen Bio actually identified their partners during pre-clinical stages, building a long term relationship and assimilating working cultures as they continued to work closely together.

Looking for partners and researching what might be available to you as soon as you possibly can will enable you to build lasting and beneficial relationships, and will also allow time for a thorough and thoughtful selection process – another key priority raised in the discussion.

 When selecting a partner, the panel agreed on a few top priorities: 

  • Technical capabilities – a partner needs to have the right technical capabilities that can serve you from start to commercialisation, where GMP manufacturing becomes critical.
  • Quality – or rather, ‘demonstrated quality’ was raised as an equally important factor, as a potential partner must have demonstrated that they can produce a quality product that will satisfy regulatory standards. A track record of success with products similar to own would be the gold standard!
  • Expertise and knowledge – especially where you may not have all the skills and expertise required in-house to address key questions in the process.
  • A customised approach – a partner who is amenable to your needs and priorities is also very important. One size does not fit all!
  • Culture – it is also important that a partner recognises what is important to you, celebrating your success as a success for them too!
  • Cost – Finally, cost is an important consideration for early stage biotechs who may not have a huge amount of money to spend, but it was agreed that it absolutely should not be a deciding factor.

“Cost is not necessarily the most important factor. If you make a decision on cost, you might find yourself paying for it later…”

Essentially, key advice here was to take sequential steps and consider your options. Is it going to be a short term partnership or a long term? Do you have an exit strategy? Deciding your position on these areas early could save you time, money and grief later in the process.

2 – Adopt a flexible approach to forming strategic partnerships

As the conversation progressed, Katie Kelleher explored the concept of early partnerships a little further, explaining that CDMOs are looking for new and strategic ways for partnering with their clients.

A strategic partnership could include a co-investment in space, or it could involve more transparency with data sharing, or it could even mean that you are involved in helping to build their own capabilities with new technologies or skills and expertise.

3 – Build resiliency into your manufacturing and supply chain

Another important step, perhaps exaggerated by the pandemic, is to consider working with more than one supplier (duel-sourcing) to build a resilient manufacturing and supply chain.

This is a strategy already established with large-scale commercial manufacturing companies, but Katie commented that the industry is starting to see companies in the clinical and development spaces also adopting this ‘hedging’ approach. 

4 – Pay attention to regulatory challenges

It’s hardly a surprise that a key early step involves regulation and standards, but the panel raised some important issues and top tips for circumventing obstacles before they arise.

Peter Marks began by recommending that first things first, you find yourself a good consultant. Use word of mouth and personal recommendations to find someone with significant industry and CMC experience, avoiding invalidated directories.

Peter continued by recommending that an early focus on the stuff that really matters to the FDA – or other regulatory and standards bodies – building good documentation of what you’re doing, documenting your controls.

Sometimes the less exciting things, Peter noted, like getting critical quality attributes nailed down and getting a potency assay, are the most important things to have determined early. Having help with a trusted consultant or knowledgeable partner to ensure a smooth and appropriate strategy in these areas could prove beneficial later in the process.

At this point, Haro Hartounian recommended that if you have any questions or uncertainty, you can always reach out the FDA to ask questions, citing his own experience with an open line of communication.  

5 – Be selective in considering your talent

One challenge, perhaps unique to smaller biotech compared to large pharma, is the competition for talent. How can smaller bitoechs compete with large salaries and benefits with restricted funds?

Once you have been selective about the level of experience you need to recruit, Peter suggested appealing to candidates with the mission of what you are doing, appealing to their curiosity for branching out and ultimately helping them to feel fulfilled.

 Another key question – raised in the Q&A – questioned what skills you should be recruiting for to have in-house, vs what skills are worth outsourcing. Hano recommended that you should make sure you have you have the science understood in a key role – for example CSO – early, and then start thinking about consultants. Haro concluded by stating that the process of acquiring and retaining talent is an evolving process from start to finish. 

As the first part of the discussion came to a close, Peter explained how it is always easier to go down a path someone has taken previously. Even if what you are doing is something new, it is likely that someone will have done something similar in the past. Look out for key examples and leverage what skills and experience might already be out there, learning lessons from negative as well as positive experiences.

Finally, I would just like to extend my thanks to the panellists for joining the Phacilitate team for such a comprehensive and insightful discussion. While I may have summarised the discussion into 5 key steps, I have by no means covered all the advice and topics covered. To learn more about ‘Identifying Priorities in Early Stage for Manufacturing Success, watch the full webinar, now available on demand.

[[WEBINAR] Identifying Priorities in Early Stage for Manufacturing Success

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