Biomanufacturing is defined as "the use of living organisms and cells to produce molecules or other biological materials for making products such as medicines, food, and drinks." https://dictionary.cambridge.org/dictionary/english/biomanufacturing (accessed February 27, 2026). However, under Nice 12-2025, in effect on January 1, 2025, the identifications "biomanufacturing" and "biomanufacture" are indefinite and overbroad because the nature of the services is unclear and may encompass services in more than one class. For example, "biomanufacturing" may encompass Class 40 custom manufacturing services that use biomanufactured materials or Class 42 laboratory services for biomanufacturing of biological materials. Thus, identifications for biomanufacturing services must clearly indicate the nature of the services to enable proper classification and facilitate informed judgments concerning likelihood of confusion under 15 U.S.C §1052(d).

Biomanufacturing includes the production of biological materials and molecules, such as proteins, microbes, viral vectors, or enzymes, from living cells. These services are commonly performed by scientists in laboratory- and cleanroom-type environments. The entry "laboratory services for biomanufacturing" was added to the Nice Alphabetical List in Class 42 under Nice 12-2025 to encompass these scientific services. Laboratory services for biomanufacturing are classified in Class 42 based on the wording "scientific … services" in the Nice Class 42 Heading and the wording "scientific laboratory services" in the Class 42 Explanatory Note. The following are examples of acceptable identifications in Class 42:

1. Laboratory services for biomanufacturing;
2. Laboratory services for biomanufacturing {indicate biological product, e.g., bacterial cell lines, peptides, yeast, etc.}; and
3. Cell culture services for others for biomanufacturing.

The biological materials created in laboratories are then commonly used to manufacture other finished products, such as pharmaceuticals, cosmetics, and animal feed. The custom biomanufacturing of other finished goods using biological materials in the manufacturing process is classified in Class 40. The entry "custom biomanufacturing of pharmaceuticals" was accordingly added to the Nice Alphabetical List in Class 40 under Nice 12-2025. Identifications for biomanufacturing services in Class 40 must indicate that the services are "custom," "for others," or equivalent wording. Additionally, the identification must specify the type of goods biomanufactured, such as fertilizers or vaccines. Examples of acceptable identifications in Class 40 include the following:

1. Custom biomanufacturing of pharmaceuticals;
2. Biomanufacturing for others of pharmaceuticals using biological organisms in the manufacturing process; and
3. Contract biomanufacturing in the field of pharmaceuticals.

For additional information about manufacturing services, see the Explanatory Note for Class 40 in TMEP §1401.02(a); see also TMEP §1402.11.