CDMO Manufacturing Technical Operations

Streamline Your Discovery’s Full Potential.

Agile CDMO manufacturing supplier expedites your concept from lab floor to commercialization

As an experienced commercial partner with full cGMP compliance, our turnkey CDMO pharmaceutical manufacturing proficiency begins with formulating or reformulating a product that either fulfills an unmet niche or expertly improves an existing product.

Our large-scale commercial operations team uses decades of expertise to provide our partners with rapid, comprehensive and cost-effective solutions for their challenging formulation development projects.

We formulate and scale up the latest ingredients, leveraging specialized equipment to create innovative and marketable new products to best serve your customers.

Your Pathway to CDMO Success Starts Here

Formulation and Reverse-Engineering

Save time and money through each production phase by getting the first phase right the first time.

We formulate over-the-counter (OTC) and personal care products in our laboratory with scalable manufacturing equipment.

We also specialize in liquid and semi-solid manufacturing, including but not limited to gels, ointments, suspensions, creams, lotions and syrups.

Scale-up

With experienced scientists, engineers and specialized equipment, we scale up new formulations from breaker to commercial processing vessels without compromising value-added service or quality.

Leading prototypes are scaled up using 1:300th and 1:30th scale jacketed stainless-steel tanks with peripheral equipment to fully develop efficient and consistent manufacturing processes cost-effectively.

Engineering

We promptly acquire important processing data to be utilized throughout validation using our engineering batching capabilities.

Engineering batching is a valuable process which allows us to study and optimize our manufacturing, filling and packaging procedures prior to validation. The engineering batch is used to collect stability data to establish the expiration date.

An engineering batch is also manufactured in the commercial equipment train to collect stability data and perform filling and packaging line trials.

Process Validation

We are thorough to ensure your early-stage project succeeds when regulators review your product filing with our industry-leading validation process.

Our engineers use the lifecycle approach to produce the appropriate protocols and reports to validate your product's manufacturing, filling and packaging.

Technology Transfer Capabilities

Our multidisciplinary tech transfer team has refined and perfected our quality oversight and process-driven approach with one goal--to formulate your product and surpass your expectations in value and on-time delivery.

Before the process starts, a full explanation of each step in our manufacturing process is paired with an aggressive timeline for commercial launch. Onsite meetings and regularly scheduled conference calls allow for a smooth transfer that ensures customers satisfaction and complete transparency.

Commercialization and Beyond

Identify opportunities for process improvements via continuous analysis through your product’s lifecycle.

Our team provides constant technical support by monitoring your commercial products and consistently complying with all current regulatory requirements.