Formulation team drive for more value
Since its start in 2013, the Formulation Point Share has been busy. Its latest article, An inter-company perspective on biopharmaceutical drug product robustness studies, was published in February 2018 in the Journal of Pharmaceutical Sciences and has already been viewed online more than 1,000 times.
A generic presentation pack and a poster about the article were also used at the AAPS Protein Aggregation and Immunogenicity meeting in August 2018, the Bioprocessing Summit in August 2018 and at Bioprocessing International Boston in September 2018.
With the help of its 23 member companies, the Point Share has shared knowledge and experience on 14 topics, including ‘Surfactants in biologic formulations’.
An extensive benchmarking survey on its latest topic, ‘Dose administration, in-use compatibility and stability studies’, is underway to share approaches for addressing development challenges. This has generated a lot of discussion about the impact of in-use compatibility on: regulatory strategy; clinical site and patient considerations; blinding, masking and placebo approaches; set-up, execution and reporting; and clinical and in-use stability testing.
One of the respondents to the survey said “Our company’s practices have been refined based on our experiences. However, other companies are doing similar work and approaching related problems differently. Sharing these experiences helps us learn and improve. Also, we might find that our practices are much the same as those in other companies, which validates our approach.”
The Point Share also features live ‘Ask BPOG’ Q&A sessions at the start of each team call. Members are asked for short questions ahead of the call, which the facilitator includes in the pre-meeting pack that is sent to attendees. If a subject is not their area of expertise, this gives them time to consult internally so they can take part in the discussion.
These interactions allow members to understand the different approaches used by their peers when tackling common product development challenges. The discussions can help the rapid benchmarking and improvement of individual practices.
Lori Burton, Senior Principal Scientist from BMS, said after the last team call “I thought it was an excellent and worthwhile discussion. It’s great to have a place like this to bounce these types of questions off industry experts and, so far, everyone has been quite excited about the opportunity to learn from feedback from such a forum.”
One of the participants said the benefit of Live Ask BPOG sessions is that “We get to hear directly the opinions of colleagues at other companies. This is the only way that I know of to hear feedback and opinions from scientists at other companies engaged in the same line of work. It is a great way to benchmark our own practices with other experts in the same field.” They also said that the sessions and benchmarking surveys mean members share best practices, so they can collectively do a better job of drug development and, ultimately, better serve the people who are using medicines.