OncoGenerix sets the NEW STANDARD in injectable process development and manufacturing services.
OncoGenerix offers a fully integrated suite of contract manufacturing services including technical transfer, process development, scale-up, equipment and process validation, formulation, filling, lyophilization, inspection, labeling and packaging, meeting the requirements of the US FDA, EMA, CFDA and PMDA.
The values of OncoGenerix focus on OPERATOR SAFETY, ENVIRONMENTAL SAFETY, QUALITY and COMPLIANCE. OncoGenerix utilizes ADVANCED ASEPTIC MANUFACTURING TECHNOLOGY and proven methods to provide cost-effective manufacturing services.
OncoGenerix operates within a highly defined, risk-based QUALITY MANAGEMENT SYSTEM reflecting the most up-to-date regulatory guidelines for the management of the product life cycle.
Advantages of OncoGenerix
Flexibility and Scalability:
- OncoGenerix’s manufacturing process is fully scalable, allowing clinical production and commercial production in the same process. We can accommodate a batch range from 1 to 1,000 liters, with a vial range of 2mL to 100mL.
Communication and Customer Focus:
- To ensure compliance, all site documents are in Chinese and English with English being the primary language of the site.
- OncoGenerix provides an empowered dedicated project manager to coordinate all activities on behalf of the client on site. Our services are focused on individual client’s requirements and goals.
Commitment to Safety and the Environment:
- Comprehensive site environmental, health and safety systems.
- Integrated liquid waste management and treatment system allows site-based treatment and neutralization or removal using certified waste management contractors.
- Defined biohazard and solid waste managements systems using certified waste management contractors.
Fully Integrated Process Development, Validation and Commercialization Services:
- Detailed evaluation of innovator product development status and preparation of strategy for process development, process validation, stability, regulatory filing and commercialization.
- Preparation of efficient and effective technical transfer and scale up plans from product clinical development through commercial manufacturing, considering the total product life cycle.
- Product process development and validation, including analytical methods, formulation, product fluid path (single use and dedicated), lyophilization cycle, container closure integrity, product inspection, product packaging and cleaning.
State of the Art Manufacturing Capabilities:
- Using ISO 5 isolator based advanced aseptic manufacturing technology located in an ISO 7 cleanroom environment, ensuring high levels of sterility and containment.
- Meeting US FDA, EMA, CFDA & PMDA regulatory requirements for clinical and commercial supplies.
- Using a QbD risk-based approach (FDA Process Validation 2011, ICH Q8, ICH Q9, ICH q10, GAMP, ISPE Commissioning Qualification Baseline, 21 CFR 211 and EU GMP regulations) within a Defined Life Cycle (ASTM E2500) for implementation, qualification validation of process and facilities. This approach uses the highest quality and compliance standards resulting in products that fully meet the clinical needs of the patient.
- OncoGenerix drives cost effectiveness through the quality management system where continuous evaluation and improvement is used to ensure a high level of equipment and process reliability and availability.
- OncoGenerix’s engineering and maintenance teams have subject matter experts for the facility control systems, and each item of process equipment. This allows diagnostic and repair of issues in-house without the need for external vendor support.
- OncoGenerix uses a high level of automation, minimizing the potential of operator intervention errors.
- OncoGenerix uses waste heat and water recovery systems to minimize utility consumption.
Open Information Sharing (Open Source):
- As a part of our commitment to our clients, OncoGenerix provides the client total access to their specific product and process technology information including procedures, protocols and data gained through realization of the product manufacturing process.
- We also provide our clients with client office facilities for on-site monitoring of the manufacturing process.
World Class Engineering Services:
- OncoGenerix has a world-class engineering team with the capability to develop, implement and qualify custom manufacturing technology from a single item of equipment to an entire facility.
- The OncoGenerix engineering team provides the client with the ability to test a manufacturing technology off-line from their facility and transfer the technology to their facility once established.
- The OncoGenerix site team is self-sufficient and has all the necessary skills to undertake equipment design, testing (including test method development, note book studies and engineering studies) qualification, maintenance and repair, eliminating reliance on outside equipment vendors.
Igor V. Ivanov
Chairman of the Board
Mr. Ivanov has more than 25 years of experience in investment business, ownership, start up, venture funding, mergers and acquisitions, strategic finance, operational management, marketing, business development, budgeting and finance. Mr. Ivanov’s excellent vision, leadership and communication skills, have resulted in the realization of multibillion dollar projects in commercial fishing, oil refining, regional development and pharmaceutical manufacturing. Mr. Ivanov has an MBA degree in business and a PhD degree in economics and is the author of many books and publications in the areas of financial management, innovative development and psychological characteristics in communications. Mr. Ivanov is the Chairman of the Board, investor, and founder of OncoGenerix.
With 26+ years in the pharmaceutical industry, Austin has extensive operations management, regulatory and process engineering experience in the EU, USA and Asia. Austin specializes in facility implementation, product development, product commercialization, strategic planning, regulatory and quality systems and is a recognized subject matter expert in barrier isolator systems, steam sterilization, sterile component handling, sterile filling of vials and syringes, lyophilizers and loading systems, automated inspection systems and the handling of complex materials including, cytotoxic substances, carcinogenic substances, biological hazards and radioactive pharmaceuticals. In addition to speaking at numerous conferences on aseptic processing and barrier isolation technology, Austin is an Adjunct Professor at Stevens Institute of Technology, NJ, where he lectures on GAMP (Good Automated Manufacturing Practices) documentation, project management and the design and implementation of aseptic processes.
Director of Quality Operations
With 30+ years in the pharmaceutical industry, Edwin is a former US FDA field investigator and has extensive knowledge of Quality and Regulatory Affairs management, technical transfer, and regulatory compliance in the USA, Latin America, EU, and Asia. Edwin specializes in establishing Quality Management System’s, cGMP training, product technical development / transfer, supplier management programs, strategic planning, regulatory and quality systems. Edwin’s experience covers a range of products including small volume parenteral (SVP), oral liquid / oral solid dosage, radiopharmaceuticals, suppositories and lyophilized products. From his work at the US FDA, Edwin has extensive experience dealing with regulatory agencies including, the Drug Enforcement Agency (DEA), MCA, EMEA, and local state / province regulatory agencies. Edwin has presented at numerous conferences on cGMP requirements, Quality Systems, FDA inspection management, basics for validation, and failure investigation systems.