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News from Europe's pharmaceutical manufacturing industry coupled with upcoming events, and exclusive articles and interviews from industry experts.
Trends and challenges of biopharma manufacturing
The whole pharma/biopharma industry is under pressure to deliver cost-effective new drugs; however, the number of new drug applications is getting lower as the size of investment is increasing. Unsurprisingly, the majority of new product development is coming from the biopharma sector, the contribution from which has increased tremendously during the last 15 years and is predicted to grow even more so over the next decade.
What’s driving the market?
The challenges to production
Productivity is high on the agenda regarding protein and peptide production. However, it’s not just about grams per litre; it’s about productivity and how to get the most out of the people and ‘stainless steel’ investment. Furthermore, you need a system that can take you from concept the gene to the cell bank and manufacturing as quickly as possible because every day costs a huge amount of money and, importantly, the time lost to market. Do not overlook including the obvious elements in product manufacture, such as making the bioprocess free of animal components, reproducible, robust, easy to scale‑up and so forth.
There are a number of mechanisms available to help create better drugs; for example, active targeting, passive targeting and improving the pharmacokinetics. Increased stabilisation of both the final product and during its manufacture; functionality with increased efficacy; reduced toxicity; and decreased amounts of administration if possible are also important should we forget these, we put ourselves in danger of becoming like Nexavar, a drug that the UK’s NICE refused to approve on the basis of not offering sufficient benefit for its cost. Failure to ensure a drug is not only safe and efficacious, but available at what is deemed an acceptable cost per patient, will almost certainly jeopardise future investment in pharma projects. Technical uncertainty and scale-up uncertainty is one thing, but to also have approval uncertainty could be suicidal. Unless you can develop the drug fast and make it relatively cheap, business will only get tougher when your drug is subsequently refused to the market by the government authorities.
Delivering therapeutic proteins
From a patient point of view he/she probably has to have relatively high and frequent dosing, and this puts pressure on the industry to get more grams per litre per day of better product. Companies that fail to deliver these types of treatment regimes in a more amenable way are going to struggle in the pharma market.
Innovation with albumin
Our albufuse technology, which provides molecular fusion of albumin to protein drug candidates for improved half-life and bioavailability is a biological, simple alternative to other technologies, such as chemical conjugation (e.g., PEGylation). An albufuse molecule is expressed as one hybrid, defined by its genetic fusion of albumin to the ‘active’ peptide or protein; for example albumin‑interferon (HGS’ Zalbin). Key benefits of this technology for developers include shorter development times, superior drug candidates, enhanced stability (during both manufacture and final formulation) and new intellectual property opportunities regarding the development of novel molecules. Manufacturers can benefit, for example, by having no post-production or conjugation steps, and having available specific matrices with which to provide a generic yet optimal downstream purification.
As developers or manufacturers, it is very easy to forget about the patient. Ultimately, your product must be about people it must be affordable, it must be accessible, it must be functional and patients must be able to tolerate it. If your product is not efficacious and affordable, it will not be needed or wanted and you will have no business.