As a biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes, Bionova Scientific works to address the toughest biopharma R&D challenges and to optimize product quality and process productivity. 

Bionova offers a comprehensive suite of upstream process development services and maintains one of the most advanced mammalian cell culture PD labs. The company’s manufacturing team works to ensure seamless optimization at all stages of development. 

In this Q&A, Bionova’s Chief Scientific Officer, Jesse McCool, Ph.D., Michelle Chen, Senior Vice President, Process Development & Manufacturing, and Minni Aswath, Senior Director of Process Development, discuss R&D challenges and approaches to meet product quality and process requirements, including derisking scale-up and tox supply by purpose-built integration of process development with pilot lab operations.

Contract Pharma: What R&D challenges do clients seek to overcome in today’s development landscape?

Clients must balance quality, speed, and cost in today’s pre-IND development activities. Outcomes from these efforts have a significant impact on success of the molecule in the clinic and in late-stage development. Platform processes can be effectively used for monoclonal antibodies while the complex modalities pose more significant challenges compared to traditional development approaches. Innovative and flexible processes must be developed to address CMC issues for the novel modalities where we cannot rely on experience and literature.

CP: What capabilities and materials are needed to overcome these development challenges?

A savvy and experienced technical team and a toolbox of proven solutions are essential to overcome challenges for process development. Coaching and mentoring can help process developers to think ahead and generate creative solutions keeping the regulatory path in mind. Close relationships with vendors and suppliers help build a robust yet flexible set of tools to address challenges that arise during development.

CP: For background, can you please describe Bionova’s pilot scale production process? What do typical pilot-scale projects include?

Pilot scale operations at Bionova serve multiple purposes: Generate material for process, analytical, and formulation development, end-to-end process confirmation (including drug product), production of toxicology batch(es) for non-human primate studies, and an environment to train and begin knowledge transfer with our Manufacturing counterparts.

CP: How does Bionova help provide a bridge to GMP scale production and what options are available to clients?

Bionova has established robust and representative small-scale models in upstream and downstream operations that provide a bridge to GMP-scale manufacturing. These standardized approaches are utilized early on in process development to ensure quick introduction of the molecule into the Manufacturing facility, more consistent processes for ease of execution and familiarity for our GMP operators and establishes more defined supply of raw materials and consumables to avoid delays.  Furthermore, the upstream and downstream equipment within our pilot plant facility mirror those used in Manufacturing to facilitate technology transfer and increase confidence the process will perform comparably and reproducibly within the GMP environment; the executed process in the pilot plant will have already demonstrated the capability to meet product quality and process requirements. 

CP: Timely delivery of toxicology material is crucial to advancing drug candidates, what are the advantages of Bionova’s pilot plant facility to accelerate toxicology material?

Bionova is well-positioned to provide timely delivery of toxicology material.  We possess two production options, GMP and non-GMP areas.  The non-GMP pilot plant facility offers many advantages, such as the continuity of scientific expertise and additional schedule flexibility; the scientists developing the processes are also responsible for generating the toxicology material.

CP: What advances do you anticipate for the future of biologic drug development leveraging these services and other technologies?

Future drug development will be based on artificial intelligence tools to accelerate analysis and documentation, greater data-driven decision-making, and incorporation of process intensification strategies during early drug development.

Click here to learn more about Bionova Scientific >>

Jesse McCool, Ph.D. has held roles of increasing responsibility with public and private companies including Lonza, as director of process development, and Cytovance Biologics where he was Chief Technology Officer (CTO) and CEO. Most recently, McCool co-founded and was CEO of Wheeler Bio, a CDMO focused on accelerating the discovery-to-development process for biopharmaceutical companies. His strategic business leadership experience is complemented by an extensive understanding of core foundational science and complex biologic manufacturing operations spanning manufacturing science, technical operations, engineering, and supply chain management.

Prior to joining Bionova, Michelle was Senior Director of Manufacturing at PACT Pharma, a clinical-stage biopharmaceutical company where she led the company’s plasmid and cell therapy manufacturing operations. Prior to PACT Pharma, Michelle led teams across multiple operational areas in roles at Sutro Biopharma and Genentech. Michelle began her career as an MSAT engineer at Genentech, eventually moving into roles of increasing responsibility in manufacturing and quality assurance. Michelle has a strong track record of leading transformational change in biopharmaceutical operations.

Prior to joining Bionova, Minni spent several years at Boehringer Ingelheim in various technical leadership roles, including protein purification, process validation, process development and technology transfer. In her most recent role there, Minni led a team of scientists engaged in downstream process development, NPI and manufacturing support, process characterization (PCS), small scale validation studies, and regulatory filings (IND and BLA). She was responsible for 10 late stage and commercial programs as the interim head of Process Validation.