Why Abzena?
Our focused approach.
Good Manufacturing Practices (GMPs) are foundational in ensuring Quality and Safety in the biopharmaceutical industry. As therapeutics become ever more complex and as a consequence regulatory scrutiny increases, understanding how to apply GMPs is more critical than ever. At Abzena, we understand that GMP s are not just a regulatory requirement but a fundamental aspect of our commitment to protecting patients and fostering trust in our company’s reputation.
Good Manufacturing Practices (GMPs) are essential for maintaining high standards of quality and safety to protect our patients and to foster trust in our company’s reputation. GMPs play a key role in ensuring the quality, safety, and integrity of products intended for human use. Maintaining current GMPs (cGMPs) is critical to achieving these goals.
At Abzena, GMPs are ingrained in every aspect of our operations. They encompass a comprehensive framework that includes:
Focusing on these critical elements guarantees high-performance standards, ensuring the biopharmaceutical products we manufacture are safe, effective, and of the highest quality.
Yes, GMP requirements do vary between clinical and commercial manufacturing. We have strong industry guidance relating to the standards required for manufacturing early-phase versus late-phase pharmaceutical products. Many in the industry refer to this as “phase-appropriate GMPs.”
In the early phase of investigational new drugs (IND), there is the necessary flexibility to develop along the product lifecycle. This stage focuses on innovation and exploration to determine safety and efficacy. While GMP compliance is essential, processes may be more adaptable to accommodate changes based on ongoing research findings. The goal is to gather critical data without compromising product integrity or patient safety.
In late-phase and commercial production, the focus shifts to locking down manufacturing processes and controls. Here, consistency is paramount. We aim to ensure we consistently deliver products that meet stringent regulatory requirements. Processes are fully validated, and controls are tightened to guarantee batch-to-batch consistency and product quality. Compliance with GMP is more rigorous, reflecting the increased stakes of supplying products to a broader patient population.
Both early-phase and late-phase products require adherence to regulatory guidelines from authorities. Regardless of the phase, the emphasis on product quality and safety remains unwavering.
Customers should focus on ensuring the proper systems, processes, facilities, equipment, personnel, and standards are appropriate to ensure the product’s quality, safety, and integrity. Quality culture is also a key element, ensuring you work with a team of knowledgeable and accountable professionals. A strong quality culture enhances product quality, improves compliance, focuses on continuous improvement and operational excellence, and boosts the overall performance within an organization.
When auditing a GMP facility, customers should assess:
We pride ourselves in maintaining a strong culture of quality from the very top of our organization. We focus on ensuring we meet the highest working standards in our manufacturing plants with a strong focus on operational excellence. We do this by ensuring our processes are directly aligned and executed against industry guidance and regulations for manufacturing early-phase and late-stage products. Abzena maintains a robust quality management system (QMS) aligned with FDA Regulations, ICH Guidelines, ISO standards, and EMA Guidelines. Our quality processes are designed to consistently monitor and control our manufacturing processes, ensuring we produce high-quality products.
Abzena’s commitment to GMPs reflected in every facet of our operations:
By embedding these practices into our daily operations, we ensure that we not only comply with regulatory requirements but exceed them, delivering products of the highest quality to our partners and, ultimately, to patients.
Good Manufacturing Practices are more than regulatory obligations—they are the foundation of our mission to deliver safe, effective, and high-quality therapeutics. By adhering to these principles, we protect patients, maintain trust in our company’s reputation, and support the success of our partners.
Our integrated approach, directly coupling discovery research and development with process development and manufacturing, allows us to stay at the forefront of innovation while maintaining the highest compliance standards. As we continue to expand and evolve, our unwavering commitment to GMP ensures that we remain leaders in the pharmaceutical industry, bringing value to our customers and, most importantly, to patients worldwide.