Technical Due Diligence Considerations For Multi-Site Biopharma Acquisitions
By Anthony Grenier
In Part 1 of this two-part series, I shared the considerations you should keep in mind when acquiring a stand-alone biopharma manufacturing facility to be dedicated to manufacturing one or several products. In this article, I’ll share considerations for multi-site acquisitions as part of a company acquisition when the seller is manufacturing part or all its products in-house.
I’ll use another real-life consulting project to illustrate this scenario: the acquisition by a North American company of a Latin American pharma company with a business including a mix of in-licensed innovative products and in-house generic products. There were in total five sites: an R&D lab, a recent solid dosage form lab for HIV products, a sterile site renovated over the years, a small facility in the city for highly potent product, and another site within the city with highly specialized product technology for two niche products.
The complexity of the due diligence was due to the fact that the seller was aware there were too many sites and had discussed but not executed some consolidation plans in the few months preceding the sale of the business. Therefore, the purpose of the technical visits was to understand each site’s specifics, discover why closure and transfer was not done earlier, and assess how relocation and integration could be executed.
In this example, the buyer was not planning to bring their products in, but rather to optimize the efficiency of the existing operations and grow the business and make it profitable.
Here, I use technology fit, capacity, and compliance as the criteria for the technical due diligence again.
While there was not necessarily a need for a technology fit for this consulting project, I saw it as an opportunity to determine whether optimization of the operations, expected by the buyer by regrouping the staff and activities, could be achieved. At first, it was clear there was no technology or equipment that couldn’t be moved from one place to another. Technically speaking, it looked positive at first sight, with no hurdles. However, I quickly realized that the reason behind the intention to close the smaller sites (the one for highly potent drugs and the one for niche products) was, above all, related to their immediate environmental impact. The manufacturing sites were initially in an undeveloped industrial area, but over the years they became surrounded by residential houses and shops. Despite following all environmental norms and adequately treating effluents, having a pharmaceutical company with potent compounds in a residential area with a social club and kindergarten nearby was deemed not socially acceptable. The challenge in transferring the work from these facilities – beyond relocating the equipment and staff – was the regulatory impact of the change in production sites. A key factor was to fully understand why the change was not done earlier; the answer, though sometimes hard to get, will inform the challenges in front of the buyer.
For a multi-facility acquisition, the level of complexity is higher, and companies should look for the weakest links that would prohibit them from bringing their product or technology to the sites to be acquired. Despite the fact that technical due diligences can last a few days, they are not exhaustive. Hence, there is a need to interview the seller and understand why certain decisions or major changes have been postponed. Companies shouldn’t hesitate to explore in-depth all possible reasons behind delayed decisions.
When there are multiple locations, capacity is more difficult to assess, whether in the aggregate or in specific locations. Companies should consider plans to optimize it.
In this example, one of the sites (the one for the HIV products) was identified as having the largest available footprint for expansion, allowing the other sites to be shut down. It is essentially industrial condos, with a large available space that can be arranged as needed. The available surface area is quite significant, and some engineering plans were already prepared.
The most important point in my understanding of the moving project and plant closure was to obtain copies of the detailed plans and, above all, the costs estimates for the facility expansion so the buyer could account for the investment and timeline in his acquisition budget.
What made my assessment overall positive is that the upper management team in place was the same one that had drawn the HIV drug plant’s layout and design. After witnessing this facility, I had to admit it was well designed to absorb the current volumes of product, and batch sizes were well adapted to the capacity of the equipment they had purchased. The flow of material was flawless and there was some extra space for possible expansion of the packaging line, which was expected to be one of the most pressing needs. These observations were validated with excellent recent inspection outcomes from regulatory agencies, with minimum to no recommendations for improvements. Additionally, the equipment purchased was high-quality and the time and effort to acquire them was the result of a meticulous analysis.
Their expertise and experience in expanding a facility to receive new products and equipment was quite convincing.
When it comes to expansion or facility closure, my advice is for companies to consider the seller’s previous experience to make sure plans are realistic from a timeline perspective and are well budgeted.
Assessing compliance in North America and Europe is common, but in other regions, it brings another layer of complexity companies should consider in their due diligence.
The challenge for me was to understand the history and recommendations from the last Latin American agencies, for which compliance requirements usually make sense in terms of cGMP, but each country tends to have some specific requirements I am not always aware of.
Overall, my technical due diligence for these Latin American sites was positive and I gave the customer a positive evaluation regarding the acquisition, with no red flags. What made the difference was the commitment of the staff to quality and making things better and their being open-minded to improving and being coached to achieve industry best practices. They knew there was significant room for improvement in what they were doing in terms of being more structured and adopting a better plan for demand. As a post-mortem, more than three years after the acquisition was closed, I was pleased to hear the customer was progressing nicely on its integration plan, with some profitability despite the pandemic.
My recommendation to companies having to assess the compliance of facilities in territories outside North America is to seek external expertise from the beginning and to rapidly identify qualified auditors who will be able to confirm any red flags.
The takeaway of this two-part series is that using back-to-basic criteria like technical fit, capacity, and compliance helps you get started on the assessment and simplify the approach, as assessing one or several facilities at a time can be a daunting task.
About The Author:
Anthony Grenier is an independent technology transfer and outsourcing consultant. A chemical engineer by training, he has completed over 60 technology transfers for both large, public multinational corporations and small specialty or virtual pharma companies spanning all major segments of the life sciences industry. He can be reached at firstname.lastname@example.org or on LinkedIn.