Type C Retrovirus-Like Particles (RVLP) are endogenously produced during CHO cell expression. As such, regulatory agencies require proof that downstream process steps can effectively remove or inactivate retrovirus. A model mammalian virus, Xenotropic Murine Leukemia Virus (XMuLV) is typically used to demonstrate RVLP clearance. However, the establishment of RVLP quantification methods has made it possible to track the removal of actual endogenous RVLP throughout the downstream process. Additionally, the recent draft of ICH Q5A revision states that, “For CHO cell-derived products, CHO-derived endogenous virus particles (RVLP) can also be used for viral clearance experiments.”

In this webinar, we will demonstrate how a highly concentrated and purified stock solution of CHO-derived RVLPs has been used as a BSL-1 compatible spiking agent for viral clearance studies. Data comparing the log reduction values derived from RVLPs vs XMuLV over multiple modes of separation, including Protein A, virus filtration, CEX, AEX, and mixed-mode chromatography will be presented. In addition, we developed a facile method of inactivating and quantifying the detergent inactivation of RVLPs.

Pharmaceutical manufacturing facilities, regardless of where they are, must meet GMP principles and procedures. There are, however, many other important and often poorly understood considerations with facility design. Beyond quality and compliance and country-specific expectations, facility design has a huge impact on decisions that both the sponsor and the contract manufacturing organization (CMO) must make.

The issues faced and questions to consider will vary depending on the circumstance. If a sponsor is seeking a CMO they need to bear in mind that they will not be able to influence the design of the facility, so they must consider how they can overcome issues if the CMO’s facility design is not an exact match for their product. On the other hand, if a CMO is building a facility, the questions relate more to what they need to do to ensure the design is most suitable for a wide variety of clients.

This webinar will explore the impact of facility design on both the sponsor and CMO.

Key Takeaways:

• Designing a facility that will be most suitable for a wide variety of clients, while ensuring those clients won’t face non-compliance issues during an audit. Suitability would include concepts such as having enough space for people, allowing space for waste materials, being able to get equipment in and out properly, and having the right technology.
  
  
• Designing a facility for a single product type, particularly advanced therapeutic medicinal products (ATMPs). What are the key considerations in that scenario? Is there potential to introduce additional product types in the future? How can CMOs optimize the design so it ensures a long lifespan for the facility?
  
  
• Including all key stakeholders in the design such as microbiologists to ensure contamination issues are considered, the core designers, and the architects and engineers. How do you bring all these key groups to an agreement to ensure the facility meets the needs of the end client?

The OPUS^® manufacturing team packed, tested, and gathered process data for > 12,000 OPUS Columns spanning 250+ resin types. Consistency is observed for efficiency and asymmetry values across each sizing segment within the OPUS Column portfolio based on statistical analysis of frequently produced configurations. Due to the control of OPUS^® Pre-packed Chromatography Column input parameters, users benefit from confidence in predictive results for output performance metrics.

Key Takeaways:

• Streamline your chromatography process by using platformable technology that scales from process development to GMP manufacturing.
• Review how Repligen measures column efficiency and asymmetry SPC trends and quantify process control through standard deviation analysis to achieve consistent column performance across formats and resin types.
• Understand impact of process control and monitoring on performance reproducibility within a single column format.