A few months ago, Eagle Pharmaceuticals agreed to acquire Arsia Therapeutics.This move will help Eagle partner with biosimilar companies to turn biosimilar candidates into biobetters. As Eagle CEO Scott Tarriff describes, the company’s business model of reformulating and improving existing small molecules is well-suited to the biologics space — especially considering his expectations of how the biosimilar space will play out.
Despite the many positive steps we’ve taken to establish the biosimilar industry today, it seems as though the success of the biosimilar market in the U.S. is still looking hazy. Every conference I’ve gone to has focused on the challenges facing the industry and concerns over the different regulations being established. But CBI’s 12th Biosimilars Summit felt particularly realistic in how it approached those issues.
One of the most dreaded problems in large scale biomanufacturing is contamination events. These events negatively impact an organization in many ways: lost batches and production time, cost of investigations, cost of decontamination, compliance issues (if there is concern that the process is no longer in control), decreased product quality and patient safety, and lost revenues, depending on the root cause. I was personally involved in defending a recurring contamination investigation before FDA, where any delay in the approval of this blockbuster would have had a negative impact of tens of millions of dollars.
Over the past year, the biosimilar industry has developed two mantras: “education, education, education,” and “strategy, strategy, strategy.” But after my conversation with HoUng Kim, the head of the strategy and operations division for Celltrion Healthcare, I’d like to add another mantra to this list: “data, data, data.”
In preceding articles in this series, we reviewed some of the challenges and remediation approaches for the storage and distribution of life science products, highlighting some of the specific risks related to storage, transportation, and material control across an extended chain of custody. This brings us to the final article, in which we will discuss best practices for selecting the partners that will be an extension of your staff for monitoring and control across an ever-changing global landscape.
In the face of patient and physician hesitance about the safety and efficacy of biosimilars, long-known innovator company brands reassure stakeholders of the company’s experience, quality, and reliability. But this begs the question, how do smaller biosimilar companies fit in?
Though there weren't any major surprises within the FDA's newly released final biosimilar naming guidance, the agency's decisions raise some even bigger questions about the identification of biosimilars in the future.
This article presents a detailed summary of the drug GMP warning letters issued by FDA in FY2016, as well as a comparison of trends in this area since FY2013. Monitoring publicly available enforcement actions and trends as part of a comprehensive GMP intelligence program is crucial, because FDA expects firms to monitor these actions and correct similar deficiencies at their site(s).
There are few better places to learn more about the state of an industry than a trade show. This past November’s Pharma EXPO, co-located with PACK EXPO International 2016 at Chicago’s McCormick Place, offered a firsthand look at some of the changes and new trends that are shaping the drug industry — including new serialization technologies and inspection technologies. Additionally, new processing equipment is being developed to handle the novel biological formulations and personalized medicines that are becoming more prevalent in today’s market. This article will discuss some of the important industry trends I observed on the show floor.
If you are considering whether to take the time in advance of your investigational new drug (IND) application submission to meet with FDA for feedback on your development program, here are some thoughts to ponder and reasons not to pass up this valuable opportunity.
To help drive sales, producers of biosimilar medicines seek to gain as much pricing advantage as possible over their products’ reference biological medicines while maintaining as much profit margin as they can. That’s why they are always looking to minimize production costs, especially in raw materials and labor, their largest cost components. While the costs of the former depend on market prices and a buyer’s negotiating skills, the latter can be best reduced through automation and continuous processing.
To continue the evolution of single-use technology (SUT) in biopharma, one area that must be secured is SUT supply chain reliability. Without this, a larger scale adoption of SUT may continue to be delayed as biopharmaceutical manufacturers must have access to a reliable supply chain that allows us to successfully deliver product to our customers.
This application note describes how perfusion cell culturing can be used to reduce processing time, simplify operations, and maximize equipment utilization in seed culture expansion processes. For creation of high-density cell banks, Chinese hamster ovary (CHO) cells were expanded using a bioreactor system operated in perfusion mode.
The PDA Journal of Pharmaceutical Science and Technology, have taught us that using materials not intended for use with pharmaceuticals was not the best choice. The industry is now evolving toward developing single-use films better suited to fit the needs of biomanufacturing, specifically, end users that have communicated a need for improved film performance with reliable supply, which requires transparency along the entire supply chain.
Despite years of discussion and experience, E&L testing approaches for single-use equipment have not yet fully matured into a consensus industry practice. Copious amounts of data have been generated by the industry, but most of it is held under confidentiality. Trade organizations, such as the Bio-Process Systems Alliance (BPSA), of which GE is a member, and suppliers have derived their own approaches to testing. For end users who are adopting single-use (SU) equipment as a manufacturing strategy, this situation becomes unwieldy. The need for a standard approach both to the generation and to the reporting structure of extractables data becomes obvious.
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