FDA Approves Flublok Vaccine for Adults

The Facility of the Year Awards (FOYA) judging panel has selected six Category Award Winners in the 2013 Facility of the Year Awards program. The winning projects were chosen from 27 entries and are located in Ireland, Switzerland, the United Kingdom and the United States.

“The FOYA program is about recognizing the pharmaceutical industry’s innovation and technical advances in facility manufacturing, which ultimately is about helping patients who need and depend upon us for a reliable supply of quality medications,” said Chaz Calitri, Vice President of Network Performance at Pfizer and chair of the 2013 FOYA Judging Panel. “The six facilities honored by this year’s awards program embody innovation, exemplified by advances in areas including flu vaccine manufacturing, which is very relevant in parts of the world right now where outbreaks have occurred, threatening public health. All of this year’s honorees are to be commended for their important contributions to our industry and, most importantly, to improving people’s lives.”  

 

The Facility of the Year Awards Program is sponsored by ISPE, INTERPHEX, and Pharmaceutical Processing. It is an annual program recognizing state-of-the-art pharmaceutical manufacturing projects that use innovative technologies to enhance the delivery of a superior project, as well as reduce the cost of producing high-quality medicines. For more information about the winning companies and their projects, visit www.FacilityoftheYear.org/FOYAWinners2013.

An innovative DNA vaccine delivery system, created by a team of researchers at the Massachusetts Institute of Technology (MIT), has broken new ground employing a microneedle equipped transdermal patch in an effort to create a robust means to administer DNA-based therapies painlessly and more effectively. 

Peter C. DeMuth, biological engineering grad student at MIT and his team of material and biological science researchers recently published “Polymer multilayer tattooing for enhanced DNA vaccination,” in the journal Nature Materials. The concept represents an amazing confluence of material science and bioscience — one that will likely leave and indelible mark on the pharmaceutical industry in the coming years. 

MIT’s research demonstrated that a transdermal patch featuring microneedles is the perfect way to administer DNA-based vaccines. According to MIT, plasmid DNA (pDNA) immunization has shown poor efficacy in primate and human trials because such vaccines, to be effective, had to be carefully injected multiple times over time. One of the more promising methods for increasing the potency of DNA vaccines employed in vivo electroporation, a complicated, cumbersome and painful method that was proving completely impractical for widespread prophylactic vaccination. 

Parallel to the technical challenges of DNA vaccination, said the paper, traditional needle-based vaccine delivery has a number of inherent issues: for one, liquid formulations typically require refrigeration, increasing costs and logistical complexity especially when considering global distribution and the “cold chain.” Past that, administering injectable vaccines — especially in the developing world — is problematic, requiring staff trained to follow safe practices and other procedures associated with needle safety.

MIT’s two-pronged approach addresses both the dose and dose sequence problem and the physical challenges associated with administering vaccines for maximum effect. DeMuth explained that to create implantable vaccine coatings researchers settled on polyelectrolyte multilayers or PEMs, which are nanostructured films formed by iterative adsorption of alternately charged polymers, that can embed large weight-fractions of biologic cargos, stabilize embedded molecules in the dried state and exhibit release kinetics predetermined by the film’s architecture/composition. “We hypothesized that rapid multilayer transfer from coated microneedles into the epidermis could be achieved via an underlying polymer film designed to instantly dissolve when microneedles are applied to the skin,” said DeMuth. To produce these releasable vaccine coatings MIT employed a photo-sensitive and pH-responsive polymer PNMP (Poly(o-Nitro-benzyl methacrylate-co-Methyl-methacrylate-co-Poly(ethylene-glycol)-methacrylate), for the release-layer.

According to DeMuth, the microneedle patches efficiently transfects cells in murine skin, eliciting enhanced cellular and humoral immune responses comparable to or exceeding in vivo electroporation. In effect, the microneedles penetrate the skin at a precisely controlled depth, and like a tattoo needle and its ink, leave the multilayer vaccine behind to be released over time as the layers dissolve. Not only is the microneedle patch cheaply mass producible from common materials, the vaccine coating is resilient, and requires no refrigeration. Similarly, the logistic simplicity of the patch means immunization programs can be quickly and cost effectively administered pain free; watch out HIV.

Viropro Inc. and Oncobiologics Inc. have signed a biosimilar collaboration agreement whereby Viropro will have the rights to manufacture six monoclonal antibody products being developed by Oncobiologics for commercialization in more than 70 emerging market countries. Viropro will have exclusive commercialization rights to the six biosimilars for Malaysia. In addition, the companies will co-manage Viropro’s Penang, Malaysia Alpha Biologics biomanufacturing subsidiary. 

The six biosimilars are generic versions of Humira, Rituxan, Avastin, Herceptin, Erbitux and one other non-disclosed biotherapeutic. According to Oncobiologics, these biologics are the most popular therapies in the world for their respective cancer and immune-disease indications, representing annual global revenue of more than $40 billion with more than $6 billion in the emerging countries covered by the agreement. The partnership is planning to launch its first product by late 2014.