How to decide between in-house GMP manufacturing and outsourcing to a CDMO when developing a new mAb, cell therapy, gene therapy, or large molecule biologic drug.

Nov 20, 2023 · CDMOs play a crucial role in helping pharmaceutical companies and biotechs bring new medicines to market efficiently and cost-effectively. A CDMO can be a one-stop-shop for bio/pharmaceutical companies, providing comprehensive services from drug development to …

Aug 10, 2023 · To navigate industry complexities and bridge resource gaps, biotechnology and pharmaceutical companies often look to third-party vendors for development and manufacturing support — most often to CROs, CMOs, or CDMOs, specifically. But …

Dec 8, 2023 · Two of the most common standards that guide how drug products are manufactured are Good Manufacturing Practices (GMP) and Current Good Manufacturing Practices (cGMP). Here are some important differences between these two standards, and what those differences can mean for manufacturers.

Apr 11, 2025 · VectorBuilder is a full-service CDMO with extensive expertise in manufacturing GMP-grade gene therapy vectors. We support the full spectrum of vector design, production and QC needs along the entire gene therapy drug development pipeline.

Apr 29, 2024 · A harmonized quality framework that is compliant with various regional and global regulations allows a strategic CDMO partner to navigate international markets more effectively.

CDMO provides MCB, WCB, and EOPCB banking service in compliance with European EMA, and Chinese NMPA GMP regulatory requirements. CDMO offers manufacturing services including cell culture by using disposable bioreactors, purification, formulation, fill/finish (both liquid and lyophilized) and package of drug product.

Apr 10, 2025 · Regulatory compliance: CDMOs are well-versed in Good Manufacturing Practices (GMP) and other regulatory standards, guaranteeing product safety and efficacy. Scalability and flexibility: They can adapt to changing project needs and scale up production as required, accommodating both small-scale clinical trials and large-scale commercial ...

Mar 19, 2025 · Stringent regulatory requirements and the need to comply with Good Manufacturing Practices (GMP) are driving pharmaceutical companies to collaborate with experienced contract manufacturers. 3 This trend is particularly evident in the production of highly potent active pharmaceutical ingredients (HPAPIs) and other specialized drug formulations.

GTP Bioways offers comprehensive CDMO services from strain development to cGMP production of drug substance and drug product. Our microbial cGMP production facility has been designed to provide maximum flexibility and is perfectly suited to supply clinical batches.