As research into harnessing the immune system's natural ability to fight disease advances, so does the development of therapeutic vaccines. Much of the attention in therapeutic vaccine R&D is aimed at targeted therapies for cancer, but substantial research is also going into therapeutic vaccines for other indications, including sexually transmitted diseases.


	eBook: Vaccine Development and Manufacturing 2017
	November 2017
	Pages: 20–24

	When referring to this article, please cite it as F. Mirasol, "Therapeutic Vaccines Target Cancer and Other Viral-Induced Diseases," 

Pharmaceutical Technology and BioPharm International Vaccine Development and Manufacturing 2017

Articles

Features

The use of therapeutic vaccines presents a new way to manage diseases, such as cancer and sexually transmitted diseases.

Therapeutic Vaccines Target Cancer and Other Viral-Induced Diseases

Facilities for advanced therapies should be configurable to flexibly segregate production for late-stage and commercial multiproduct operation. Efficient design of a flexible and high-containment vaccine manufacturing facility that can meet all the challenges presented by the market requires a design philosophy that includes all the key control concepts: air, people, equipment, product, and liquid and solid waste. This article discusses best practices for such control and describes the use of modular, mobile cleanrooms.

Pharmaceutical Technology and BioPharm International

Vaccine Development and Manufacturing 2017

	When referring to this article, please cite it as T. Page, "Designing and Operating Flexible, High-Containment Vaccine Manufacturing," 

Pharmaceutical Technology and BioPharm International Vaccine Development and Manufacturing 2017 eBook

A new facility type integrates next-generation mobile cleanroom systems.

Designing and Operating Flexible, High-Containment Vaccine Manufacturing

A human challenge study offers several advantages when testing drugs or vaccinations for infectious diseases, because proof of efficacy can be measured in humans across a defined period of infection as the exact time at which exposure to the infectious agent is known. Usually this knowledge as to when infection takes place is unknown, and therefore it is also undeterminable as to where on the disease cycle the subject is. Sampling events are scheduled to take specimens at critical periods, and symptomology is carefully monitored throughout. 

	When referring to this article, please cite it as A. Wildfire, "Using Human Challenge Trials to Develop Flu Vaccines," Ph

armaceutical Technology and BioPharm International Vaccine Development and Manufacturing 2017 eBook

Challenge trials may increase in coming years as new and improved challenge agents better emulate “natural” disease states. 

Using Human Challenge Trials to Develop Flu Vaccines

Vaccines have had a tremendous impact on human quality of life, increasing life expectancies by eradicating deadly diseases.  The cost of developing and manufacturing vaccines remains extremely high, however. Given unprofitable prices, improving access to vaccines has been a major challenge.  Despite these problems, innovation is reaching a new level, while new approaches to manufacturing and distribution involving non-government organizations and contract manufacturers offshore have helped improve access.  This article touches on some of the innovations, and the types of business models that have made them possible, and includes an interview with the director of the Sabin Institute.

	When referring to this article, please cite it as A. Shanley, "Making Vaccines Accessible," 

Despite the challenges and high cost of development, vaccine innovation is at an all-time high, as new approaches aim to improve global access.

Making Vaccines Accessible

As the authors write, true sterile manufacturing remains an impossible ideal. In the real world, even the slightest contact with operators can contaminate product.  While aseptic processing has brought the industry closer to its goals, closed aseptic processing takes progress much further, by using automaton and isolators to prevent contamination.  This article examines general trends but focuses on a technology that has been developed by Medinstill, that significantly reduces the risk of contamination and allows unclassified rooms to be used to process materials, instead of costly cleanrooms.

	When referring to this article, please cite it as J. Agalloco and L. Mestrandrea, " Moving to Closed Systems for Aseptic Processing," 

Alternatives to time-consuming, error-prone operations promise to reduce vaccine manufacturing costs and improve facility flexibility.

Moving to Closed Systems for Aseptic Processing

With advancement in vaccine development comes an urgency to optimize the cold-chain delivery of these increasingly condition-sensitive biological products. This sensitivity has added new degrees of complexity to already complex supply chains and global regulations, resulting in the need for more precise approaches toward transporting vaccines. 

	When referring to this article, please cite it as A. Lowry, " Cold Chain: Delivering Vaccines to Patients," 

This article explores some of the challenges, services, and technologies that go into ensuring that vaccines are properly temperature controlled and maintain product integrity for delivery to patients.

Cold Chain: Delivering Vaccines to Patients

Established vaccine manufacturing technologies are complex, often highly customized, and typically require dedicated facilities. Development and approval times can be lengthy, presenting hurdles for medical professionals seeking rapid response to pandemic diseases.

	Standardized vaccine manufacturing platforms that can be deployed across different vaccines and vaccine types, could speed the delivery of vaccines and enable manufacturing in emerging economies. Technical and funding challenges must be overcome to bring the advanced manufacturing potential to reality.

	When referring to this article, please cite it as C Challener, " Accelerating Vaccine Development and Manufacturing," 

The use of approved platform technologies can reduce the time and cost required to generate new vaccines.

Accelerating Vaccine Development and Manufacturing

Most vaccines available today are still manufactured using antiquated, low-yield, and labor-intensive process technologies in capital-intensive facilities. This lack of manufacturing flexibility drives high cost of goods, diminishes affordability for developing countries, and reduces the market incentive to address smaller patient populations. Improved manufacturing technologies can enable more efficient and cost-effective processes. This article discusses the potential of using high-productivity membrane chromatography to achieve intensified and flexible virus manufacturing.

	When referring to this article, please cite it as R. Jacquemart et al., “Achieving Intensification and Flexibility in Virus Purification with Next-Generation Chromatography Tools,” 

 Vaccine Development and Manufacturing 2017 eBook (November 2017).

This article discusses the potential of using high-productivity membrane chromatography to achieve intensified and flexible virus manufacturing.

Pharmaceutical Technology-11-15-2017