Glossary Definition: Batch Manufacturing

What is batch manufacturing?

Batch manufacturing is a step-by-step batch production method that allows companies to complete multiple unit operations at once, either in parallel or sequentially. This method captures all the needed equipment, materials, resources, and data that goes into making a product so that there can be traceability and genealogy of how the product was made. In this way, batch manufacturing helps companies satisfy customer demand and improve quality control.

Who uses batch manufacturing?

Batch manufacturing is a popular production method in many industries, including consumer electronics, baked goods, clothing, cosmetics, and pharma. Let’s take a look at how it works in the tastiest of these industries: baked goods.

Bakeries employ batch manufacturing when they create large quantities of cake to ensure they’ll have enough to last the day. These “batches” may supply the bakery itself, or may support third-party bakeries. The process takes several steps to complete and involves turning raw ingredients into finished products (or in this case, delicious cake).

In this scenario, the cakes are all from the same batch even if the components are all completed by different people at different times. The icing, which can be made separately from the cake itself, represents an additional “unit operation” that can be completed either in parallel to the bake, or at a different time.

What are alternatives to batch manufacturing?

Batch manufacturing is the tried and true production method for most industries because it’s a trusted process. However, there are several alternatives to this method, including continuous manufacturing and lights-out manufacturing.

In the continuous manufacturing model, the supply of raw materials, procedures, and drug outputs are ongoing and uninterrupted to maximize production. However, it’s important to note that this is not yet feasible in full-scale biologics, and currently functions as a supplement to batch manufacturing instead of a replacement for it.

In the lights-out manufacturing model, the manufacturing process is fully automated and requires no human involvement during production. Similar to continuous manufacturing, achieving this fully is currently more of an aspiration in the pharmaceutical industry than a reality. In addition, there are a number of potential complications to consider for pharmaceutical applications of this method.

What is batch manufacturing in pharma?

Batch manufacturing in pharma is a step-by-step production process to manufacture a specific quantity of drugs. It involves a series of steps, often thousands for complex biologics. After each step, additional tasks can be completed such as moving materials to a different site, conducting quality checks, or reviewing equipment.

Batch manufacturing is the grandfather of pharmaceutical batch production because it’s reliable and allows pharma companies to produce specific amounts of therapies, tailored to meet market demand.

Why is batch manufacturing important in pharma?

Batch manufacturing is important in pharma because it is an approved, time-tested way to manufacture drugs. In fact, it is currently the only method that fully supports pharmaceutical manufacturing throughout the full drug production lifecycle.

Batch manufacturing allows pharma companies to track the traceability and genealogy of the drug: who was involved in making it, and how and where it was made. This is especially helpful in the case of recalls, and helps to streamline a number of other tasks such as quality control and recipe adjustments.