Improve Quality + Reduce Cost
Our Areas of Expertise
With 20 years of R&D and Manufacturing experience, we can help your operation scale, gain efficiencies in cost, efficiencies in quality and manufacturing, and solve difficult and critical problems, fast.
Single Use Technology
With increasing mAb titers, fewer blockbusters and advances in cell and gene therapy, single-use (disposable) systems are in high demand. Selecting, or designing, the systems, suppliers and technology you need in a way that achieve the following:
Meets your timelines
Satisfies development and manufacturing needs
Maximizes closed processing
Minimizes lifetime costs, sku’s and inventory
Assuring best practices in design, component selection/qualification and materials of construction is our expertise.
Tech Transfer & Commercialization
Some of the most challenging steps in commercialization involve the transfer of skills and knowledge relating to assay methods and their validation, criticality of materials and their procurement and qualification, and communicating equipment, automation and facility requirements for commercial manufacturing that ensures comparability to the clinical development phase and that the QTPP will be met during PPQ.
We specialize in scale up into pilot scale and commercial manufacturing, and have successfully accomplished it for mAb’s, enzymes and viral vector at scales up to 17,000 L and with platforms ranging from batch, to perfusion and to highly manual lab-scale operations.
Quality & Continuous Improvement
Commercialization of a product is a major milestone and it is accomplished through good science, a skillful and focused development organization and good operational execution. While the development and initial commercialization focus on speed, scale up and GMP compliance, the post-launch routine manufacturing phase will focus more on continuous improvement over time. It’s here that improving process control, knowledge management, enhancing quality and business systems and minimizing costs / reducing waste become important. We excel in this area.
With experience ranging from major internal quality improvement projects to consent decrees, reducing controllable operating costs and improving tech transfer processes, we are ready to help scale your manufacturing operations in an efficient and Quality-focused way that keeps pace with your pipeline growth and industry standards
MiRAMAR CMC Services
Short Term
Raw material risk assessment, second sourcing and qualification. Best practices to minimize costs and meet compliance goals be selecting and negotiating with supplies and reviewing quality agreements and questionnaires.
Process validation and CPV program development.
Audit and 483 support.
New technology evaluation.
Extractables and leachables programs.
Troubleshooting of manufacturing process yield, quality and consistency problems
Long Term
Single use and stainless steel facility fit analysis and start up, including equipment specification and single-use strategies to maximize flexibility and minimize costs.
Functional specifications authoring for MES and electronic batch record projects.
Commercialization of cell therapy processes, including particulate minimization and qualification.
Quality system enhancements, including error reduction and continuous manufacturing and process improvement.