Oral Solid Dosage

CRB’s Oral Solid Dosage (OSD) thought leaders are a team of experts recognized for their comprehensive experience and authoritative knowledge and skills. Bringing multidisciplinary expertise from across the spectrum of OSD, they understand your unique challenges, apply their knowledge to determine the right solution, and drive successful delivery of your project from planning to start-up.

Facilities Optimized From The Inside Out

A well-designed process is central to any successful OSD facility. With today’s rigorous requirements for high purity processing, increasing needs for containment, contamination control, quality assurance and regulatory compliance – process engineering needs to be the driver behind an OSD facility project.

At CRB, optimization of an OSD facility starts with the process because it is so important – far beyond the simple architecture and engineering of a suite. Our OSD experts know what it takes to manufacture solid dosage forms. We understand the process elements, and consequently we know how to best design a facility – from the inside out.

Flexibility & Efficiency

Particularly relevant when updating aging sites, facility designs need to accommodate flexible throughput and process technology. There is also continual internal and external pressure to make production as efficient as possible and more cost effective, driven especially by more highly potent compounds and orphan drugs being produced at lower volumes, and novel drug delivery platforms.

Regulatory Compliance

Facilities need to meet regulatory requirements, with a focus on product protection and quality by design. With the increasing prevalence of potent drugs, health & safety requirements (OSHA & EHS) are increasing for many new products. CRB’s in-depth understanding of cGMP and regulatory guidelines enables us to focus on protecting specific critical product quality attributes, and streamline the process by controlling critical process parameters.

Innovation

CRB’s thought leaders bring expertise in cGMP, optimized product quality, lean manufacturing, reduced time-to-market and cost efficiency. The focus on these means that OSD facilities are leading the industry in terms of innovation in continuous manufacturing, process analytical technology (PAT), and other areas – with the active involvement of the FDA.

Continuous Manufacturing

CRB has unsurpassed knowledge of the requirements and potential benefits of continuous manufacturing (CM). CM is not a one-size-fits-all approach, and there are many options and configurations for the user to enter the arena. Fully integrated CM systems are among the most complex to implement; however, they also represent a growing number of installations around the world, allowing for the widest range of capabilities. Partially integrated and hybrid continuous CM systems offer a great launch pad and entry for the user to enter this arena. Direct compression systems are among the most popular and easiest to implement. Advanced end-to-end continuous CM systems are truly transformational and offer exciting potential but have the greatest complexity of all. Our team will work with you to define if this direction is right for your business.

CRB’S OSD Thought Leaders

Dave DiProspero – Director, Pharmaceutical Process Technology
Mike Wilson – OSD Process Architect
Todd Vaughn – Process Engineering Specialist
Wit Lehmann – Senior Pharmaceutical Specialist
James Golden – Process Equipment Specialist
Jeffrey Fedor – Potent Compound/Containment Specialist
Martie Hart – Procurement Manager
J.T. Cochran – OSD Owners Representative
Renee Benson – OSD Packaging Specialist
Matthew Wilbanks – Senior Project Director

Speak to our experts today.