From lab to market: The scaleup hurdles facing The Apprentice’s Browtasia

The 20th series of The Apprentice has returned to UK screens, with 20 entrepreneurs competing for Lord Alan Sugar’s mentorship and £250,000 (US$342,000) investment.

Among the line-up is pharmacist and former Geordie Shore personality Roxanne Hamedi, who is seeking backing for her brow-growth business Browtasia.

With operations based in a single UK laboratory, Hamedi says her vegan brow pomade and loyal customer base make the business ready for global expansion.

For chemical engineers, her pitch highlights a familiar challenge: scaling a laboratory formulation into a regulated commercial product. Investment is only one of the many hurdles when moving from lab-scale to manufacturing.

“My simple advice would be to get in bed with big business,” says Darren Oatley-Radcliffe, an associate professor of chemical engineering at Swansea University, who has extensive experience in pharmaceutical scaleup. “They will be able to help in developing the product, navigating the regulation, and they have the funds available if the product is right for them.”

According to Oatley-Radcliffe, the path to commercial scale is extremely difficult for small businesses, especially those operating in pharmaceuticals and personal care.

Materials and equipment

Experience is key when scaling up and Oatley-Radcliffe stresses that companies should have in-house expertise and reliable access to equipment and materials.

In practice, funding often eclipses both. Businesses must buy or lease equipment and hire specialist contractors, which can be prohibitively expensive.

“As most small businesses will not have the infrastructure needed to scale up, they will need to rent or lease items of equipment or go to a contracting house that has the available equipment. This is not cheap,” he says.

Even with investment, firms may struggle to access intermediate-scale equipment.

Oatley-Radcliffe explains: “You can buy a lab-scale and industrial-scale spray dryer quite easily. However, buying one at pilot scale, say the size of a domestic refuse bin, is almost impossible. This is true of a number of technologies or unit operations and is most likely to a low number of sales at this scale of operation meaning that there is no financial incentive for companies to build them.”

Regulation

What sets health-related products apart is the complex regulatory landscape they must navigate before reaching market.

“Any new product that is related to health and wellbeing that is rubbed on the skin, ingested or injected will be subject to regulation,” says Oatley-Radcliffe.

In the UK, businesses must comply with Medicines and Healthcare products Regulatory Agency (MHRA) regulations, while the US requires approval from the Food and Drug Administration (FDA). Each market has its own requirements and companies must comply with all relevant regimes.

“Due to the nature of the regulatory approval, you will need to generate a range of data to prove that your product does what it says on the tin – the ‘Ronseal test’,” he says.

“If a defective product or a customer has a reaction to a product, then the ensuing court case will rely on the data generated from the R&D scaleup process. This means that all of the data generated needs to be conducted under a given quality standard, ie GLP, and the data must also be stored in an appropriate way.”

Big pharma partnerships

Across his career, Oatley-Radcliffe has been involved in the scaling up of multiple pharmaceutical products, including treatments for atherosclerosis, allergic rhinitis and cardiovascular disease. He notes that pharmaceutical development success rates can be as low as one in 10,000.

With such odds, he encourages startups to partner with large pharmaceutical companies, which already have infrastructure, expertise and capital in place.

“Once you have registered your new product with the regulatory authority you will then tell the world what you have, so you will need to patent it to protect the intellectual property (IP),” he says. “At this point, you have no sales and regulatory approval may be another three to five years away.

“This is the case for big pharma. Approval may well take longer for a small company to achieve and as the time slips away, so does your patent life and there are a million and one generic producers out there waiting to pounce.”

For Hamedi, The Apprentice offers visibility and potential investment – but the real test will come after the boardroom. Scaling Browtasia from a single laboratory to global production will require engineering expertise, regulatory navigation and significant capital.

As Oatley-Radcliffe advises, partnering with established industry players could be the difference between a promising formulation and a sustainable global business – a challenge that may ultimately be tougher than surviving the boardroom and avoiding a “You’re fired!”.