Current good manufacturing practices (cGMP) are central to drug manufacturing, helping to produce chemicals and other raw materials in accordance with specific controls and quality systems.
The development of pharma and biopharma products requires materials as well as the expertise on how to use them.
Despite what cGMP stand for in terms of drug quality and consistency, studies indicate that only half of biopharmaceutical developers use cGMP chemicals in early-stage clinical trials.
In this article we are going to speak about how the use of cGMP raw materials in the early stages of drug development process can minimize the risks and accelerate your development milestones.
We go beyond raw materials, as we understand your need for safety, security and scalability to get healthcare solutions to patients faster.
Raw Materials for Biopharmaceutical Manufacturing
Often, Research Use Only (RUO) raw materials are used in early stages, but these materials are not subject to the same rigorous manufacturing and quality controls as cGMP raw materials.
Due to the rapid development of complex biologics and the ever-present pressure to advance production, the use of non-compliant raw materials can be catastrophic. This is because variables that could be inadvertently introduced by the use of RUO chemicals could result in rework and potential rejection of entire batches of finished drug product.
The use of cGMP raw materials earlier in the drug development process can minimize these risks.
A smooth transition
The International Council of Harmonisation (ICH) and many other regulatory governing bodies generally stipulate that cGMP-manufactured materials and suppliers should be introduced after the completion of preclinical trials.
But it is demonstrated that early adoption of cGMP chemicals can make the transition from research phase to clinical production seamless. By doing so, the real conditions under which the drug will be used in the first-in-human (FIH) trials are better simulated.
Moving into FIH trials requires added validation and qualification, which is time and resource intensive. Planning ahead for these compliance and quality standards can help greatly minimize cost and complexity.
Chemicals manufactured under cGMP standars carry the expectation of high quality. They are sold with comprehensive certifications documenting the conformance of each manufactured batch to published standards.
Plan for success
Assessing supply availability as well as the quality of your chemicals, even for RUO, and establishing relationships with trusted suppliers can go a long way toward mitigating supply disruptions that may arise.
In our opinion, once your data support a move to clinical trials, it is worth seeking out a quality supplier and manufacturer. This can ease your way in later stages, as the need to move quickly means taking time to organize materials, document processes, and plan for transition.
Better inputs make for better outputs.
Bringing cGMP into your workflow sooner can help free your team to focus on what they do best: creating life-saving medicines.
Selecting a quality supplier with experienced in cGMP, will help you reduce risk and support you from early clinical stages all the way through to commercialization.
Working with 53Biologics will save you a lot of scale-up headaches. Through our global relationships with manufacturers and suppliers, our services not only streamline pre-production processes, but also keep production moving in compliance with quality and regulatory standards, helping you approach every step of your biomanufacturing workflow with peace of mind.
Let´s Talk! Arrange a meeting with our expert team to discuss your biologic manufacturing project.