OncoGenerix USA can undertake a detailed evaluation of products in development and recommend strategies for regulatory approach, process technology selection, and scale up from clinical to commercialization. While evaluations are always product specific, the following are typically evaluated:
- Proposed manufacturing process review, including incoming, in process and release testing requirements.
- Product contact part.
- Container closure selection.
- Formulation, including temperature control, modified environment processing and mixing technology.
- Product contact system assembly and sterilization, cost-benefit analysis of using single-use versus reusable equipment.
- Product filter selection.
- Filling and lyophilization technology evaluation based on product characteristics.
- Product inspection and packaging requirements.
- Cost analysis to realize product, including regulatory fees, unit manufacturing and distribution based on targeted markets.
Requiring only a short time to undertake, this service is highly valuable because: (1) it allows innovator companies to commercialize their activities beyond the research laboratory; (2) streamlines the manufacturing process; and (3) reduces the time to market and profitability.
Technical Transfer Services
OncoGenerix USA provides access to a dedicated technology transfer team who follow clearly defined procedures to transfer products into the manufacturing facility. Working in close cooperation with our clients the technical transfer process encompasses the following steps (depending on product need):
- Process GAP Analysis: The process to be transferred is evaluated against the facility manufacturing process baseline. Where a GAP is identified, a process change will be developed through engineering studies. Once the change is verified, the process change is implemented and validated, fully integrating the client’s process into the manufacturing baseline.
- Supply Chain: Based on the requirements of the product and process, the material supply chain for the project is implemented. The supply chain is based on the requirements for test method verification and validation, process GAP studies, bench studies, process and validation, stability filling and stability studies.
- Bench Studies: When required the formulation will be prepared at bench scale and tested under accelerated conditions at T=0, T=15 and T=30 days. Once the formulation is verified as stable and (if applicable) the lyo cycle is verified as effective, a process scale up study will be undertaken.
- Test Method Development and Validation: Based on the requirements of the product / process Standard Test Methods (STMs) will be prepared. USP, EP & CP test methods will be used as the basis for the STM and test method verification will be undertaken. For unique test methods (in house), the test method will be developed, verified and validated.
- Process Scale Up Batch (Engineering Batch): Once the bench studies have been completed, a process scale up batch will be prepared and tested under accelerated conditions at T=0, T=15 and T=30 days.
- Stability Filling: Once process scale up has been verified, stability filling will be undertaken. A range of stability testing conditions are provided, including photo stability.
Contract Filling Services
Our focused approach allows for a seamless scale up from clinical to commercial manufacturing using the same manufacturing and quality management system baseline. Contract manufacturing services include:
- Toxicology batches.
- Phase I, II and III clinical batches.
- Commercial batches:
- 100,000 10mL solution vials.
- 50,000 10mL lyo vials.
For customers constructing their own facilities and who wish to minimize the time associated with facility commercialization—launch manufacturing services are also provided, allowing simultaneous product development and commercial launch with facility implementation.
Engineering and Technical Services
OncoGenerix USA provides access to a highly experienced world class engineering team. The engineering team integrates the client’s product process into the facility manufacturing process baseline and can, if necessary, assist clients with design and implementation of novel process systems and technologies. In addition to contract manufacturing services, the following engineering and technical services are offered (for injectable vial, syringe, cartridge and ampule projects):
- Facility design and implementation:
- Facility / process capacity analysis.
- Process technology options analysis.
- Facility Layout Definition.
- Process Design and Implementation:
- Process Equipment Layout / Specification.
- Process Equipment Procurement.
- Construction Management.
- Facility Qualification and Validation:
- Equipment Commissioning.
- Equipment Site Acceptance Testing.
- Installation / Operational Qualification.
- Supply Chain Implementation.
- Quality Management System Implementation.
Based on client’s needs and objectives, the engineering team can undertake an individual study or provide a fully-integrated suite of services including supply chain and quality management system implementation.