Manufacturing Misery in Vaccines - Pharmaceutical Technology

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Manufacturing Misery in Vaccines
Vaccine manufacturing was predicted in 2008 to be on the cusp of a golden era, but instead the industry has experienced cost pressures, high-profile liability cases and production setbacks.


Pharmaceutical Technology Europe


Other vaccine disruptions

In October 2012, Crucell, which is based in the Netherlands and provides approximately 10% of the UK's influenza vaccine stock, halted production after discovering problems with two of its product batches. The company has stated that it is continuing to conduct quality tests before releasing any more vaccine, although it has not recalled any of the stocks that have already been distributed. The manufacturing issues at Crucell are particularly frustrating for Johnson & Johnson, which finalised acquisition of the company in 2011 for $2.4 billion, with the aim of accessing the global vaccines market. The acquisition was Johnson & Johnson's largest since 2006, when it took over Pfizer's consumer unit for $16.6 billion. For now, Johnson & Johnson will be preoccupied with resolving the manufacturing issues and reassuring their existing vaccine clients before the company can pursue its intended ambitious growth plans in the sector.

Another company that has recently suffered vaccine manufacturing issues, although not for anti-influenza products, is GlaxoSmithKline. In October 2012, the company cooperated with Australia's Therapeutic Goods Administration for a voluntarily recall of six batches of Infanrix hexa, a vaccine product used to prevent diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis (polio) and Haemophilus influenzae type b (Hib). Testing had revealed low-level contamination in certain batches dispatched between August 2011 and January 2012, although the company stressed that no reported adverse events had been directly linked to this issue. Later in October, the company recalled a single lot of the same vaccine in Canada, citing potential microbial contamination, but continuing to state that it was purely a precautionary measure (8). In November 2012, GlaxoSmithKline confirmed that the affected batches had originated from its plant in Rixensart, Belgium (9). Potential microbiological contamination had been identified in the environment where bulk antigens for some of its Infanrix Hexa, Infanrix-IPV and Infanrix- IPV/Hib vaccines were placed, but release tests (including sterility tests) on intermediates and on the final containers led to the conclusion that the final products released from the facility had not been contaminated (8). The company continues to resolve the issue, but the recall of these products may have an impact in up to 20 countries. As well as many EU Member States, countries such as Lebanon, Malaysia, Qatar, Brazil and Vietnam may be affected by short supplies of the vaccine (9).

Future

Vaccines are essential to combat a range of disease threats and the migration of companies out of the sector has worried health agencies worldwide. Efforts have been made to stimulate renewed industry interest and persuade companies that it is an ideal opportunity for them to harness scientific advances made in genetics and biotechnology. There are signs that these factors are persuading some companies to increase their activities in the vaccines sector, but as recent experience shows, manufacturers face considerable technical challenges. After a troublesome last quarter of 2012, Novartis now appears to be on the verge of resolving the manufacturing issues it has faced with its influenza vaccines. Canada and Switzerland lifted their bans in late October, followed by Singapore and then Italy in the first part of November. However, the company still needs to work with authorities in other countries to allow supplies to resume. For other companies, such as Crucell and GlaxoSmithKline, efforts to restore confidence in their vaccine expertise look likely to continue through 2013.


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