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Rapid Technology Transfer

Strong Collaboration from the Start

We have executed hundreds of successful product technology transfers. The key to this success is our strong partnership with our pharmaceutical and biotechnology customers. We offer the collaborative mindset and the scientific and technological problem-solving experience to ensure efficient and effective transfer of analytical and manufacturing processes from the start.

Efficient and Effective
Project Management

Before a partnership begins, it is important that a confidential disclosure agreement be in place and that the prospective customer issue a detailed request for proposal (RFP) including specific project requirements. The Simtra BioPharma Solutions proposal responds to the technical considerations outlined in the RFP and lays out project execution assumptions, costs and timing. Once the project is awarded, contract negotiation starts with a collaborative kickoff meeting between customer and Simtra at our facilities, resulting in a defined project scope and a comprehensive project plan.

Following contract approval, the project moves forward. Throughout this process, we bring to the table a team that includes a dedicated account executive, a seasoned project manager and experts representing the supply chain, R&D, technical services, quality, regulatory and sterility assurance functions.

A Responsive and Expansive Supplier Network

Our strong relationships with vendors allow for expedited purchase or production of necessary manufacturing equipment and supplies (such as tubing, filters and tanks) and product components. We also have the ability to use customer-supplied materials if desired.

Ready R&D Support and
Robust Standard Processes

Our well-equipped R&D scientists are readily available to offer all necessary analytical services and to expedite any technical issues that may arise with product formulation, often acting as liaisons between our customers and our internal quality control teams during product transfer. Our team of experts is also available to provide support post transfer. Manufacturing and technical team members collaborate on decision-making to achieve the best fit between product and process.

Our R&D and Lyophilization Center of Excellence teams are co-located at our manufacturing facilities, which helps to streamline the formulation development process and to ensure a smooth transition from laboratory to commercial scale.

Global Regulatory Experience

We help clients manufacture products that reach more than 120 countries worldwide, so we have broad experience with numerous regulatory authorities and understand their unique requirements. Our facilities themselves comply with FDA (United States), PDMA (Japan) and EMA (European Union) regulatory standards, and our global regulatory inspection history is strong. Our proven expertise in adhering to global regulatory requirements for quality control helps enable us to minimize compliance risks and potential production delays.

Contact Us

Learn more about our rapid technology transfer services.

Related Resources

Bringing Your Sterile Injectable Product to Market: Considerations for Collaborating with a Fill Finish CDMO

Considerations include RFP timing, specificity of the RFP and the proposal, close candidate evaluation and a collaborative approach on scope and timeline.

Scale-Up and Tech Transfer

When lyophilized products move from lab- to full-scale production, considering the differences in equipment design and capability aids in process scale-up and transfer.

Vial Breakage During Lyophilization

Simtra understands the root causes of vial breakage during lyophilization and can apply mitigation strategies to avoid it.