Moving Forward with BioReliance by SAFC

Last week, BioReliance President, Charlie Harwood shared information about the background of the company before it was purchased by Sigma-Aldrich, and a bit about what sets it apart. As we revisit the topic this week, Charlie offers a further look into the technologies behind the business and the future of the industry.

Hi Charlie. In your last blogpost, you said that you were proud of BioReliance and its reputation. What are the key elements you believe contribute to this reputation?

In a high value business such as biopharmaceuticals, manufacturers have to be certain that their products meet all necessary standards – not only do product withdrawals and plant closures cost significant sums of money; they also have an extremely negative effect on the company’s reputation. Our expertise helps protect them from these potentially expensive and impactful effects.

We begin each relationship with close consultation with the customer to define the correct testing regimen up front. The protocol we determine will reliably demonstrate that there is no detectable contamination. In the event that a positive result is found, then we work closely with the client to pinpoint the source of the problem as quickly as possible to minimize the impact on their bottom line.

What are the main types of business that BioReliance serves?

Our main types of business are large molecule (biologics) and toxicology services that are particularly for small molecule drugs. The common thread for these is that each line involves similar types of biological lab techniques, even if the substrates are somewhat different; the ability to carry out high-quality work and meet the most stringent regulatory standards, whether GLP or GMP, is in our DNA. But, importantly, our deep understanding of the regulatory environment and the scientific and technical expertise of our scientists enable us to provide all our customers, whatever business they happen to be in, with the precise biological safety tests and services they require, and full confidence in the results.

Can you give us an example of how the process works in practice?

Well, a couple of customers have come to us to help them develop a cell line for making a new vaccine. Traditionally, vaccines are produced in chicken eggs, but this is a slow process and uses a lot of eggs as one is required for each individual dose. It also has the potential to introduce microbial contamination from the egg. These customers were looking for alternatives to eggs, and developing cell culture processes that would give better speed, flexibility and scalability for manufacturing. We have been developing a new testing technique that is extremely useful where we can apply massively parallel sequencing to perform a more extensive characterization of the cell line. The sequence is then run against a database of all potential contaminating microorganisms to evaluate whether anything unexpected is present.

Anything unexpected needs to be explained, and in the past the process has largely been an exercise in ticking boxes on a checklist. By applying this sequencing approach, the approach is wider, giving a more comprehensive picture of the cell line. California-based biotech PaxVax has already used this biological safety testing process in one of its pipeline cell line products which has been submitted and approved for manufacturing use by the FDA.

What differentiates your testing technologies from others in the market?

In such a highly regulated field, it is important to have reliable tests that are accepted by the authorities. However, gaining this acceptance can take some time. In terms of individual lab techniques, these are well known and other companies also carry them out. What sets us apart is the broad portfolio of these tests that we are able to offer our customers. We pride ourselves on our service in terms of both time and quality, and the way that we partner with our clients to ensure they get exactly what they need. We deal with around a thousand clients every year – which not only keeps us busy but gives us a huge depth and breadth of experience.

What trends do you see in the field at the moment?

The major new trend is definitely the product genomic testing platform that we have developed. Related to this is the rapid increase in information being garnered through molecular and genomic techniques. Genomics in particular creates a huge amount of data, so it’s important also to be able to analyze these data – data are only as good as the information that can be gleaned from them. That aside, another big trend is the development of lab methodologies that improve the turnaround time for results, whether the test is being carried out in the early research stages of a product’s development, at the end of the process on the final product released to the market, or at any point in between.

What advantages does being a part of SAFC offer BioReliance?

As an expert in biomanufacturing, SAFC has developed a huge array of products and services to support clients. While biomanufacturing support services and products is a fragmented field, the combination of SAFC and BioReliance offers a full spectrum of capabilities for the production of critical raw materials for manufacturers in this area to ensure that they are safe. SAFC already had one of the broadest offerings in the field before the acquisition, and I can speculate that SAFC will continue to develop this, both organically and through further acquisitions.

The more we are able to connect all these pieces, the better it will be for all our customers. Importantly, BioReliance’s testing operations are distinct from SAFC’s other capabilities, such as the manufacture of media and buffers – SAFC is making products, while we are offering a service. This distinct focus should ensure that the differentiation of our capabilities in the market does not become blurred.

Becoming part of SAFC has not disrupted our operations, and they recognized that specialized sales and support are required to deliver these products and services to clients. Customers have not seen any difference in the level of service they receive, and we do not expect this to change. The integration has mostly happened in admin areas such as finance, human resources and IT to help the businesses connect and communicate. Of course, in future we will develop new ways of selling services and products across the business, with customers learning the advantages of the broader business.

Where do you see SAFC and BioReliance in five years’ time?

SAFC already has the broadest array of products and services supporting biomanufacturing, and as I said before I am certain that this will continue to grow. BioReliance, meanwhile, was a unique company. While it was initially something of a challenge to put the pieces of the two businesses together, this has now been done and we can start building on it. Yes, BioReliance could have remained independent and continued to be the leader in biosafety testing, but by joining SAFC we have gained the ability to connect with a broader array of support services and products across the biomanufacturing space. The trick will be working out how to bring these products and services together – and build or acquire others – in a way that adds more value to our clients than had we remained separate entities.

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