SR&ED case study for the food industry: Cutting down Lactose

This week we are giving you a look into what can be a potential SR&ED project. For this particular case, we focus on how a company may need to conduct tests to optimize their current procedures. This case study is entirely fictional. 

The natural sweetness found in milk is a result of a milk sugar known as lactose. At a young age, most people can digest lactose by an enzyme called lactase which cleaves it into the more digestible sugars, glucose and galactose. Overtime, a considerable subset of the population experiences a variable decrease in lactase production leading to lactose intolerance. Undigested lactose that passes through the digestive tract ferment causing unpleasant effects such as bloating and flatulence. Then came the advent of lactase pills allowing lactose intolerant individuals to enjoy dairy goods too. However, the level of lactase deficiency directly influences how helpful lactase pills can be for the consumer wherein people with severe deficits barely benefit from this oral supplementation.  

Company A identified a highly potent subtype of the lactase enzyme which can digest up to a thousand times the amount of lactose than what was previously in the market. They currently provide liquid lactase to large dairy manufacturers generating lactose-free food products; however, they want to venture into creating lactase supplements to give directly to consumers. They believe that their product can provide some relief for even those who consider themselves highly lactase deficient.  

After finalizing the pill, Company A set up test trials with volunteers who graded themselves as highly or completely lactose intolerant individuals and who were unresponsive to available lactase pills. However, when they gave volunteer participants liquid lactase it was much more effective than the desiccated lactase pill. After several more trials, they determined that while liquid lactase had 100% enzymatic activity, the pill only recovered 5-30% of enzymatic activity after oral delivery.  

Results from the experiments pointed that there may be an issue with recovery of the pill once it enters the digestive tract. Thus, Company A decided to launch a project to investigate potential variables that can maintain or enhance enzymatic activity after oral delivery.   

What is the uncertainty that is to be resolved in this project? 

SR&ED projects revolve around resolving a scientific or technological uncertainty. 

In this particular situation, the uncertainty to be resolved is how the desiccation and subsequent packaging procedure of lactase pills impacts enzymatic activity after reconstitution in the digestive tract. The importance of this revolves around creating a highly effective approach to help individuals with severe levels of lactose intolerance be able to digest the compound better. Moreover, their work can help to contribute to better isolation of enzymes in other contexts. 

How does Company A intend to determine what factors impact the lactase processing procedure?

Another important factor about SR&ED projects are their design in terms of creating a comprehensive approach to the problem. Below we outline some factors that are potential culprits and how Company A intends to approach the problem. 

Acidity is measured by pH and while most of our bodies is maintained at a neutral pH of 7, the stomach is as low as pH 2. While the liquid lactase is accompanied in a solution that can help neutralize some of the acidity in the stomach, the pill does not. Company A hypothesized that stomach acidity levels can impact the functioning of the enzyme pill. To test this, they reconstituted the pill in solutions with different pH levels 

After a couple of months, did Company A find anything with their tests?

Company A found that they were partly correct. Differing pH levels affected the enzyme recovery and therefore they packaged the pill with a component to counter this. However, this only allowed an increase of enzymatic activity to 50% relative to liquid lactase. This led to Company A hypothesizing that their desiccation procedure may be impacting activity since it has a high temperature step. This could damage the enzyme leading to its low activity levels. They will attempt to use a different purification and desiccation method that uses lower temperatures to isolate their protein and test lactase activity.