How do you measure success? In the life sciences industries, success depends on quality, validation, regulatory compliance, product safety, efficiency and profitability. Insufficient control and bottlenecks, however, can negatively impact your manufacturing processes. System enhancements can improve your profitability, but only if you avoid setbacks related to overtaxed resources, schedule slippage and unrealistic project estimates. Process analytical technology (PAT) practices have made improvements easier to implement, but once a process is working and validated, the steps involved with changes are complex. Forward-thinking companies who are proactive and rise to meet these and other challenges will benefit in the short term. The ability to improve processes and embrace smart manufacturing technology, even in a regulated and validated environment, is key to sustainability and future success.
MAVERICK Technologies® identifies key operations and improves performance for greater safety, efficiency and overall profitability. We provide biotech, pharmaceutical and medical device manufacturing consulting and can work with you to implement the right solutions that support your process, helping you produce your drug and device products better. For example, we can help you maximize throughput, improve asset reliability and ensure quality and regulatory compliance.
All our solutions comply with 21 CFR Part 11 requirements, GAMP V Model and ASTM standards for a range of capabilities, and we can deliver the full benefits of PAT, Factories of the Future including single use technology (SUT), and serialization concepts to reduce cost per drug. With our extensive expertise, we can support your team and provide a complete business perspective — making improvements from the plant floor to the boardroom to optimize performance at every level.
MAVERICK’s customers in the life sciences and biotech industries have benefited from our industrial automation, enterprise integration, system migration, consulting, commissioning and sustaining services. Leveraging our unique enterprise-wide perspective, we encompass all areas of biotech and life science manufacturing processes and equipment, including bioreactors and fermentation systems, media preparation, spray dryers, centrifuges, purification (chromatography, UF / DF), active product ingredients, fill and finish, lyophilization, clean in place, steam in place and water for injection.
- A specially assembled team of trained, certified professionals with the skills needed to deliver life sciences solutions in the country where you work.
- Capabilities in enterprise-wide services, from automation to business-level IT solutions.
- Deep expertise and knowledge of best practices for the life sciences industry.
- Knowledge of best practices gained from working in related industries, such as consumer-packaged goods and food and beverage.
- Expertise in laboratory information management systems.
- Track record of adhering to budgets and timelines.
- Platform-independent, scalable solutions that utilize your existing infrastructure.
- Proven Project Complete® methodology for meeting critical objectives with consistency and repeatability.
- The OpCon Advantage, combining the right people, process and technology to ensure project success.
- Data enablement, bring data to life from clinical trial to full-blown manufacturing.
- Batch solutions that provide S88 flexibility.
- Turnkey solutions and main automation contractor (MAC) capabilities.
- Building and Environmental Automation Systems.
Business and Technical Analysis
Develop scope definition, estimation, risk assessment, vendor and life cycle analysis, alternatives, schedule and financial plan / justification.
Project Execution and Implementation
Develop project specification, detailed design engineering, configuration and programming, procurement, deployment, installation, schedule and risk management as well as all documentation and good manufacturing practice (GMP) validation life cycle steps.
Checkout, Commissioning and Startup
Provide project support, including loop checks, dynamic testing, training, turnover documentation and GMP validation life cycle steps.
On-Going Support Services
maintain project gains once the project has been fully commissioned, including preventive Maintenance, instrument calibration and repair, software maintenance and configuration support, cyber security, corrective and preventative actions.