RSSL’s Phil Kuhlman, Technical Specialist, Biopharmaceutical Analysis, and Dale Hreczuk-Hirst, Biopharmaceutical Business Development Manager, look at the advantages of using an outsourcing partner and, most importantly, how to find the right one. During the past 20 years, the biopharma market has expanded rapidly and there is no sign of this growth slowing down. As the understanding of disease targets continues to improve, the focus has moved from chemical hits on disease molecules to biological hits. Capacity has increased steadily, and the processes for making biopharmaceutical drugs have now become part of the everyday industry toolbox.
“This is probably the time of greatest change in the industry,” says Phil Kuhlman, Technical Specialist, Biopharmaceutical Analysis, at RSSL. “There is a move from small molecule to larger molecular drugs as the biologics toolkit creates new approaches to treat diseases that small molecule drugs could not address a decade ago. We are now able to tackle diseases that were untreatable 10 years ago.”
Furthermore, the regulatory environment for getting drugs to market is changing: production runs are much smaller and there is an increasing focus on orphan drugs aimed at far lower patient populations. Typically, these drugs have a shortened regulatory path so they can get to market quicker, and the companies that are developing them and taking them through Phase III trials and on to commercialisation are often much smaller than was previously the case. Smaller companies may not have much experience in the analytical side of research and is likely to turn to an outsourcing partner to support its activities.
“In light of these trends, an outsourcing partner needs to be more technically adept and more flexible than ever before,” says RSSL’s Dale Hreczuk-Hirst, Biopharmaceutical Business Development Manager. Targeting rarer and rarer diseases with smaller numbers of patients will involve greater flexibility … and will require an outsourcing partner that is not only able to keep up but has the ability to drive the product to market more quickly.
“Another major area of opportunity for the outsourcing sector is biosimilars. The growth in the number of biosimilars coming onto the market will drive down prices” Hirst suggests, and manufacturers will turn to outsourcing partners as a more cost-effective alternative to having their own analytical team or making a significant capital investment in analytical instrumentation.
Furthermore, biosimilars require a large number of tests. Seven years ago, it was necessary to compare three lots of the biosimilar against three lots of the innovator molecule in a full barrage of approximately 20 tests. But, for the last 3 years, everything that comes onto the market has to be tested at the beginning, middle and end of its shelf-life. “So, we’ve moved from a three-lot comparison to a comparison of up to 30 or more lots, each of which must be tested three times,” Hirst explains. “With biosimilars, it all revolves around knowing everything about the innovator molecule.”
Quality and experience
Not only can using an outsourcing partner be cost-effective, it can also bring a level of expertise that may not be present within the biosimilar manufacturing company. Executing a comparative study for the first time is a very different proposition from using a partner who has done it many times and built up considerable experience, Kuhlman points out.
Knowledge and technical expertise are two of the most important considerations when biopharma companies are looking for a suitable analytical outsourcing partner, along with flexibility and range of equipment. For Hirst, the key is technical expertise: in the first place, to save time so that costly errors don’t occur; and secondly, to advise the client and avoid expensive time delays.
The quality side of outsourcing is, of course, the bedrock of any partnership, but these days it’s a given: provided the partner is FDA inspected and MHRA approved, it is guaranteed to operate at a high quality standard. RSSL is not only FDA and MHRA approved, it’s also one of the best equipped service providers across a wide range of analytical technologies. The company covers 95% of the needs of most clients, although it still subcontracts some activities, such as tissue culture and bioassays to specialist partners.
Of course, not all players in the biopharma sector are looking for the same things from their analytical outsourcing partner. Small, spinout companies, for example, who have taken their idea as far as Phase II, may need further support in the form of expertise in getting to market and navigating the regulatory pathway. Alternatively, medium-sized companies and contract manufacturers may just need additional capacity to cope with peaks in workload, whereas larger biopharma companies may be looking for extra capacity or to scale-down their own operations to reduce costs.
But there’s more to selecting an outsourcing partner than merely finding a laboratory that can offer the required testing services. The focus should not just be on the immediate need for a service but should take into account the broader picture and how that relationship might grow in the future. “The selection of your outsourcing partner is critical,” says Kuhlman. “If you find a partner that can do the tests, that’s great; but, if anything goes wrong and that partner can’t complete the investigation or can’t discover why product is out of specification, then it ultimately ends up being more costly in the long run. Reliability and the building of trust in the relationship is absolutely crucial, and that’s what we offer.”
Customer service is seen as something of a cliché these days, but flexibility, good communication, consistently meeting deadlines and putting the client first whenever possible are all prerequisites for a long-term relationship. It’s not all about the tests, Hirst agrees, it’s about when clients are in trouble and need help. And that help is available 24/7, 365 days a year.
RSSL offers a wide range of expertise, concerning not only the large molecule but also raw materials, contamination issues and packaging analysis throughout the product lifecycle. For any given project, a multidisciplinary team will be put together, with consultants on hand to fill in any areas not covered in-house. The reliability of a potential outsourcing partner is another factor to take into consideration. RSSL is financially stable, has been in the industry for many years and intends to be around for many more.
“It’s a matter of trust,” Kuhlman stresses. “If you are trying to release your multimillion pound product onto the market, you really don’t want a CRO to hold that up. You need to have the trust that they are going to get the job done. That is the key to successful partnerships.”