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Formulation Services

Formulation development is a critical process in the creation of safe, effective and stable biotherapeutic products. Primarily, it involves optimizing the composition of a biopharmaceutical drug substance and/or drug product to ensure its efficacy, safety and stability throughout its shelf life. More specifically, it consists of selecting the right combination of excipients for storage and patient administration.
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Two scientists working in a lab. One had a pipette raised

Key objectives of formulation development

  • Stability and shelf-life

  • Safety and efficacy

  • Delivery and bioavailability

  • Container compatibility 

Labcorp operates its formulation development workflows to quality by design (QbD) principles as outlined in ICH Q8 (R2) (Pharmaceutical Development) and ICH Q9 (Quality Risk Management), with the initial production of a quality target product profile (QTPP) to identify the desired target product formulation attributes.

We recommend that formulation development is performed early, in line with process development, and to minimize subsequent process and analytical validation issues. However, formulation development is often a protracted process as increased understanding of the product warrants modifications.

Our formulation services

Pre-formulation

Forced degradation where little is known about the routes of degradation

Pre-Formulation Services
Two scientists walking down a hallway. One is holding a tablet while the other one is using his hands as he explains

Nucleic acid-LNP using microfluidics

mRNA and other nucleic acid therapeutics encapsulated in lipid nanoparticles (LNPs)

Nucleic Acid-LNP Using Microfluidics Services
Cationic lipoplexe structure. Cationic lipoplexes are one type of Lipid Nanoparticles (LNPs) used for gene delivery. Nucleic acids intercalated between the lipid bilayers. 3d illustration

Monoclonal antibodies (mAbs) and antibody-related products

A focused formulation development workflow to minimize the analytical load for antibody therapies

mAbs and Antibody-Related Services
A microscopic image of an antibody