Contract Pharma: What pharma/biopharma macro trends are you seeing and how are they trickling down to impact aseptic fill/finish operations?
Paul Ruther: The biggest trends we are seeing that affect aseptic fill/finish operations are the ever-tightening regulatory demands. They are trickling down in forms of tightened particulate requirements, the need for PUPSIT (Pre-use Post Sterilization Integrity Testing), and the increasing push to isolators.
CP: What are the most important trends in fill/finish outsourcing today?
PR: For outsourcing, the markets for biosimilars and the need to push products quickly into stability batches, process validations, and commercialization are ever increasing. ADCs, high potency antibody drug conjugates, are also trending upward.
CP: How would you describe the current state of the aseptic fill/finish outsourcing market?
PR: It is a growth market for the companies that can maintain compliance and a solid regulatory track record.
CP: What are the key new technology innovations making an impact?
PR: Isolators and modular systems are making a big impact on the industry. Another popular innovation is the constant changes in sterile connectors, making them easier to use for technicians while maintaining its integrity.
CP: Where do you see the market down the road, say in 5 years time?
PR: I see requirements that continue to remove the fill operator, human factor, in a fill room. Isolators and isolation systems will continue to evolve and their use will be more and more wide spread.
CP: What is the latest news at Althea on the fill/finish front?
PR: We have an ADC facility that will be online soon.
CP: What are your thoughts on the emergence of fill finish facilities in developing regions?
PR: They are needed to satisfy the ever-increasing demands for vaccines and medicines in these new markets. As long as they can produce high quality materials, you will see an increase in numbers of this type of facility.
CP: What about the use of complex administration systems such as novel prefilled devices? Is this the wave of the future?
PR: I don’t think this is a wave of the future, it is here and it is now! Obviously, these types of products will evolve as the markets expand, but any administration system that makes it easier for the patient to maintain compliance will be requested by manufacturers more and more. Anyone who can handle these systems and the increasing demand will have a special niche in the market.
CP: How is increased serialization and product labeling to improve anti-counterfeiting impacting fill/finish ops?
PR: Again, this becomes a compliance issue with regulators. Anyone who can continue to evolve with industry, such as serialization of individual units, will set the tone for the industry as well. Anyone who cannot keep up will slowly fade into the background. Failing to recognize where the industry is moving and more importantly what the expectations of regulating bodies are is a mistake companies cannot make. You can find yourself out of compliance quickly at that rate. CP