Preformulation, development and technology transfer

With many new drug candidates receiving designations allowing for accelerated approval pathways, CDMOs supporting small and emerging pharma companies developing small molecule injectable drugs must have the process understanding and physical capability to implement projects within dramatically shortened timelines. Familiarity with project management and quality systems at both companies can also facilitate rapid completion of product developments and tech transfer projects.

Flexibility and Understanding Matter

With many new drug candidates receiving designations allowing for accelerated approval pathways, CDMOs supporting small and emerging pharma companies developing small molecule injectable drugs must have the process understanding and physical capability to implement projects within dramatically shortened timelines.

Familiarity with project management and quality systems at both companies can also facilitate rapid completion of product developments and tech transfer projects.

Learn more about technology transfer

Lifecycle management

Extending the product lifecycle by improving features, reformulating or switching from one type of container to another. 

Product lifecycle management should start as early as possible and be part of the product strategy portfolio in order to remain competitive. The right approach when choosing a CDMO should be to consider those that are able to offer development and manufacturing in different types of containers. This will enable a long-term relationship between both companies as strategic partners. Working with the same CDMO for both containers means saving time, money and being able to rely on someone you already trust.

Learn more:

- Lifecycle Management
- Advancing Patient-centric Parenteral drug strategies
- Parenteral Manufacturing Market Trends

Commercial manufacturing

Grifols Partnership has two FDA- and GMP-approved manufacturing facilities in Spain for intravenous solutions that have parametric release certification.
High manufacturing capacity to offer your product on time.
Our high level of automation minimizes human interaction with the products, provides higher levels of safety, and reduces potential risk of contamination. Grifols manufacturing facilities are designed to accommodate products that require terminal sterilization with autoclaves (water and steam).

Form-Fill-Seal technology

Four new Form-Fill-Seal lines, two of which are fully automated, have been designed to manufacture 50 ml, 100 ml, 250 ml, 500 ml and 1000 ml, PP bags.

Clinical batch manufacturing

GMP clinical batches is also offered as part of our pharmaceutical formulation and development service. Our facilities are designed with equipments to manufacture clinical and commercial batches.

Regulatory support

As new developments arise, Grifols Partnership offers regulatory support services as part of sterile contract manufacturing solutions, providing technical documentation, safety sheets and certificates of analysis to our customers to submit the file for registration in the selected markets.