A Silver Milestone for Drug Development - - BioPharm International


A Silver Milestone for Drug Development

BioPharm International
Volume 27, Issue 8, pp. 6

This month, BioPharm International’s sister publication, Pharmaceutical Technology Europe, marks its 25th anniversary of publishing technical papers, articles, news, and product information about drug-development processes in Europe. Anniversaries are the time to mark progress and project future potential.In a special issue, the editors of Pharmaceutical Technology Europe and experts from various sectors of the bio/pharmaceutical industry share perspectives on technologies, trends, and events that were key influencers in the development of drug therapies. While I share some of the highlights here, the complete content can be found on www.pharmtech.com/PTE25.

In “No Signs of a Slowdown in Mergers,” Faiz Kermani reflects on shifts in drug company ownership in the past three decades. In 1985, the top 10 pharmaceutical companies accounted for approximately 20% of worldwide sales. In 2012, the top 10 companies captured 42% of global sales, he writes. Reasons for mergers included improving R&D productivity and increasing revenues to compensate for lost sales of drugs losing patent protection. Another incentive for acquisitions is to expand to emerging markets, which are growing at a faster annual rate than Europe, the United States, and Japan.

The use of contract service providers also expanded over the past 25 years, says Eric Langer, president and managing partner of BioPlan Associates. Borders and location have become less important, relative to a supplier’s technical, client service, and quality competence. In 1989, there were only a few biopharmaceutical CMOs and few biopharma companies that outsourced tasks. Instead, some companies purchased up- and downstream subsidiaries to ensure they were vertically integrated. This strategy did not work for many companies and outsourcing, especially in bioprocessing, became more common in the early 2000s.

Sean Milmo tracks the evolution of regulatory oversight and enforcement in Europe, from legislative activity in the 1950s to introduce stricter regulations following the discovery that thalidomide caused birth defects, to the establishment of the European Medicines Agency. Experts also provided predictions of technology approaches in key areas.

Biosimilar drugs have gained approval in Europe, including monoclonal antibody products. While development costs, naming issues, and payer resistance present some challenges, the future looks promising.

Single-use technologies have moved from small-volume storage to standard practice in key areas of biopharmaceutical production. Experts say that further advances are needed to resolve some operational limitations.
“In the past five years or so, single use (SU) approaches have brought about a significant change that will continue into the future as SU becomes more commonplace,” writes Günter Jagschies, GE Healthcare Life Sciences.
Friedrich Haefele, head of Biopharma Fill & Finish Germany for Boehringer Ingelheim, describes how maturing aseptic technologies can create more flexible facilities for emerging biologics. Boehringer Ingelheim received an ISPE 2014 Facility of the Year Award for Equipment Innovation in its aseptic drug-product manufacturing area at the company’s Biberach, Germany site.

Safety and security threats have resulted in drug packaging changes. Advances in needle shielding have helped reduce needle sticks by medical personnel, Rüdiger Manthey, Bausch+Ströbel. Serialization is a major trend and future challenge for the pharmaceutical industry, as manufacturers implement regulatory requirements for different regions, writes Johannes Rauschnabel, Bosch Packaging Technology.

Rita Peters
Rita Peters

About the Author
Rita Peters is the editorial director of BioPharm International.

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