Specialized research and development (R&D) labs including contract organizations (CROs, CMOs etc.) in all sectors are under extreme pressure to develop new formulations quickly (as fast as possible) and effectively (as close to specification as possible). Responding to requests from competitive manufacturers, these formulators are typically experts in their fields – they are full of knowledge and previous ‘recipes’ that can be used to advance projects. But when the clock is ticking to deliver a new drug or ‘limited edition’ flavor their knowledge may be missed or not used if no one on the project team knows they know about it! The problem is obvious: lost time and rework that can add both cost and time.
Key to turning out the goods efficiently lies in knowing what ‘stock’, both physical and virtual (the ones in peoples’ heads) is on the shelf and what was produced previously in a similar scenario. It’s about having a clear picture of that data and formulation information, understanding it and being able to build on this knowledge base with contextual data such as: What were the best temperatures to create a certain coating? What were the exact conditions in which one flavor excelled? What coating and milling process gave the best dissolution profile for a tablet to optimize pharmacokinetics (PK)?
It’s typically the same across sectors, although each has its nuances with business and formulations challenges manifesting themselves slightly differently. But fundamentally they all need to know what has been done before and what properties their formulations possess.
In pharma, formulations and reformulations is often about finding a delivery mechanism for an active pharmaceutical ingredient (API) to optimize PK and pharmacodynamics (PD). The basic principles of recipe management and formulation apply. In this sector, however, regulation is of course a key concern. On delivery, R&D organizations must be able to prove that they have changed only the format of the drug product, not the properties of the API in any way. The process however is under pressure to be as fast and robust as possible.
In food and beverage organizations, the main concern is building out a recipe for a product which can be released in a matter of weeks/months. More often than not this will require speedy turnaround with little time to reinvent the wheel. For example, they need to be able to see all the cola flavours they have ever made so that they can choose the most appropriate for tweaking in line with the requirements from the customer. Organizations in this space must also consider food regulations and a clear audit trail for traceability purposes – so regulation, whilst different to drug products, is as important.
Fast moving consumer goods (FMCG)
The FMCG challenge is similar to food and beverage but these types of organizations must also pay particular attention to what works well across demographics. For example, people in the UK like a certain face cream formula which doesn’t leave a sheen and soaks in quickly, but in Asia it is the opposite – consumers like to know they have put a cream on so it tends to be thicker. Organizations must reformulate to meet regional demands and be able to do it as fast as possible without impacting the health and safety aspects – environmental impact of raw materials and ingredients is of particular interest here due to the mass market nature of products produced and therefore the levels of material that enter the environment. Imagine how much shampoo gets washed down the plug hole every day across a large population demographic!
The basic formulation problem in all of these sectors is how do I know what I have now, what has been done before and how can I redevelop/repurpose it effectively to meet a particular demand? Whether it’s adding an orange tang to a candy bar, a tropical scent to shampoo or reformulating a hay fever pill into a spray, having the right software in place to optimize the process of formulation development and reformulation based on what has gone before will ensure a smooth and speedy delivery.