Speciality chemical company Rohm and Haas has created a new business unit, Advanced Biosciences, that specialises in the production and purification of biopharmaceuticals. The new unit is well placed to address the shortfall in production capacity which has been tipped to impact the sector over the next few years, according to the firm.
Discussing the thinking behind the move, Carol Eicher, who was promoted to the position of vice president and worldwide business director for biopharmaceuticals earlier this month, told a news conference that the pharmaceutical market is undergoing significant change. There is a migration away from traditional chemistry-based drug development and towards the production of biopharmaceuticals i.e. drugs manufactured using active biological agents as the principal raw material.
At present, biopharmaceuticals represent only around 10 per cent of the total number of drugs on the market, but this is set to change; more than 350 biologicals are currently in clinical trials and the US Food and Drug Administration approved 35 biotechnology-based medicines and vaccines in 2002, she said.
Despite the promise of biopharmaceuticals, manufacturing capacity constraints "are already causing new drugs to be slowed from market development and introduction because their manufacturers cannot find suppliers to make the quality and quantity of critical media they need in a dependable and consistent manner. Other significant projects are not even being pursued because of uncertainty about cost and available manufacturing scale of critical manufacturing components," according to Eicher.
Biopharmaceuticals are currently produced through three primary technologies; cell culture; fermentation and chemical synthesis, she noted, and it is in the latter two areas that Advanced Biosciences can boast a significant presence. The unit's Amberlite and Amberchrom resins are already well-established in the market for purification, solvent removal and molecule recovery, and these have now been joined by Ambersynth, a solid-phase synthesis resin which is suitable for use in processes up to commercial multi-tonne scale.
Advanced Biosciences executives told the press conference that there has been a trend away from recombinant production techniques to solid-phase synthesis of peptides, because the latter approach provides yields of higher purity and, potentially, peptides with enhanced properties. One of Rohm and Haas' core competencies is functional beads, which stem from the firm's 60-year-old ion exchange resins and coatings business but also form the basis of all Advanced Biosciences products, including Ambersynth.
"The performance of the Ambersynth resins in coupling reactions provides substantially improved process economics in large scale production environments," noted the company. These economic gains come from faster cycle times, lower process solvent use (and associated disposal costs), and fewer recoupling steps, providing a productivity gain of around 25 per cent compared to rival media, it said.
In effect, Rohm and Haas has taken its existing biopharmaceutical technologies and built a new business around them. This has involved establishing a dedicated product development team and direct sales and marketing organisation. Manufacturing will be carried out at Rohm and Haas' existing sites in France and the UK but will be overseen by a centralised Advanced Biosciences management team, said Eicher.
The company is also putting in place a network of specialised distributors for its products to build a global reach; many of these have already been selected and will be trained in Advanced Biosciences' product portfolio over the next six months.