Germany's Rentschler Biotechnologie and Boehringer Ingelheim have inked a preferred partnership agreement to jointly offer customers a more streamlined biopharmaceutical production option.
Under the deal, Boehringer Ingelheims clients will be entitled to use Rentschler's facilities.The contract manufacturer is focused on process development and small to medium-scale clinical supply production of mammalian cell-derived drugs, and currently operates eight independent GMP lines with fermenter volumes of up to 500 L, with a 2,500 L fermenter also due to start operations. In return for access to these facilities, Rentschler's clients will gain access to Boehringer Ingelheim's large-scale mammalian biopharmaceutical production facilities in Biberach, Germany. The company's services division, runs one of the world's largest biotech facilities and offers similar services to Rentschler, but with technologies optimised for large scale industrial production with fermenter volumes of up to 15,000 L. According to the two companies, the advantages for its biopharma customers are that the combined development and manufacturing know-how and facilities will lead to "increased flexibility and ultimately more customised services". The companies' sites are located in close vicinity to one another and they share compatible bioprocessing methods, which "guarantee a seamless project transfer," the firms pointed out. "The cooperation with Boehringer Ingelheim will increase the value of our services, as both companies will benefit from the combined expertise and the easy transfer from small/medium to large scale production," said Dr Wieland Wolf, vice chairman of the Rentschler Group. Prof Rolf Werner, corporate senior vice president of the Corporate Division Biopharmaceuticals, Boehringer Ingelheim said: "Rentschler Biotechnologie is a strong partner for process development and supply of clinical material in Europe and complements our worldwide strategic Production Alliance Network". "Based on compatible process technologies and Boehringer Ingelheims proprietary know-how and expertise in high titer and high yield manufacturing process formats we will combine state-of-the-art development at Rentschler for accelerated time to clinic with a smooth technology transfer to Boehringer Ingelheim for large-scale commercial manufacturing". The partnership comes at a time when new opportunities are being created for biopharmaceutical contract manufacturers as this corner of the pharma industry matures. According to new research from Frost & Sullivan, the strengthening of mid-size biopharmaceutical companies is serving as the engine for a rapidly growing biopharmaceutical pipeline and is a strong signal for future potential that exists in outsourcing manufacturing. With that in mind, Frost & Sullivan has estimated that the biopharmaceutical CMO market will grow to $6.48bn by 2014, witnessing double-digit growth from its present value of $2.45bn, with demand being largely driven by first-generation products - recombinant human protein therapeutics and monoclonal antibodies (MAbs) targeted for cancer. Contract manufacturing of biopharmaceuticals has also moved beyond simply being a function of "available capacity" and "cost" to a strategic option offering flexibility, quicker time to market, and lower scale-up costs, the firm said. However, overall capacity utilisation by the biopharmaceutical industry has continued to decline since 2003, as a result of this continued industry expansion, improvements in yield at existing facilities, and efficiencies associated with production, while at the same time, certain segments of the industry, including larger biopharmaceutical developers, are still experiencing capacity constraints. In Europe this is a particular problem, with the region being tipped by BioPlan Associates to witness the most significant worldwide gains in biopharmaceutical manufacturing production capacity in the next five years - 66 per cent compared with only 36 per cent in the US - due to demand.
With these considerations in mind, companies in the business are needing to become more innovative and efficient in the way they operate, and the Rentschler Biotechnologie and Boehringer Ingelheim partnership is one example of this.