Today’s biopharmaceutical manufacturers face a wide range of challenges. The regulatory landscape has become more scrutinizing as it has grown increasingly complex. Supply chains have grown into supply webs, with intricate logistics and compliance issues. Competition — and pressure to cut costs — keeps climbing along with the rate of mergers and acquisitions. And all the while, companies can never be too efficient, too quick to market or too flexible in responding to demand for new vaccines or other drugs.
With so many factors to consider, biopharmaceutical manufacturers must constantly seek solutions for ensuring compliance, improving efficiency and enhancing flexibility to become more adaptable to shifts in market demands.
The Rise of Single-use Systems
Single-use processing systems continue to rise in popularity among biomanufacturers. Once sparingly utilized, single-use solutions have evolved into whole production lines that can replace many fixed, hard-piped systems. For example, recent advances have made even cell harvesting more efficient. Today, an end-to-end processing system – from bioreactor to filtration technologies – can be fully disposable. Production can be set up in a matter of weeks rather than years, making it easier for companies to move operations between markets or cost-effectively meet demands for small batches. In some cases, companies can save 40 percent in capital costs by designing a facility based on single-use systems rather than a conventional facility.
Single-use systems can also reduce the challenges of scaling up operations after approval – or if production must be ramped up in the event of a pandemic. Most importantly, single-use solutions can prevent cross-contamination between batches without the more time-consuming validated cleaning practices associated with hard-piped systems.
Inspection Speeds Up
Whether a supply chain spans the U.S. or the entire globe, measures must be taken to ensure consistent quality and safety. To do this, companies are leveraging high-speed inspection technologies such as optical scanners that provide 360-degree inspection of pills, tablets and capsules. Other systems employ automated detection methods to facilitate compliance with cGMP, and particularly 21 CFR Part 11 protocols, which are enforced by the FDA and EMA. Moreover, some of the new technologies enable better data collection and quality control, helping manufacturers build more robust reporting structures as they manage increasingly large and diverse supply chains under more scrutinizing regulatory bodies.
… Speaking of Regulations
Integrating new equipment under the oversight of multiple regulatory agencies can pose many hurdles. The International Society for Pharmaceutical Engineering (ISPE) is working to promote a more robust dialogue between manufacturers, suppliers and global health authorities with the goal of greater global implementation of innovative technical practices which could lead to improvements in the overall regulatory review and approval process, accelerating the pace of production and ultimately improving the delivery of medicines to patients.
From ensuring compliance to speeding time to market, biomanufacturers face many challenges. However, through innovations such as advanced single-use systems and innovative technical practices companies can overcome these hurdles and drive business growth. Pharma EXPO (Nov. 2-5; McCormick Place, Chicago) will serve as a resource for insights and solutions in supply chain management, technologies to increase line efficiency and more. The show will bring together processors and packagers from the pharmaceutical, medical device, nutraceutical and biotech industries to offer solutions for the entire supply chain. Co-located with PACK EXPO International 2014, the event will provide a unique opportunity for a cross-pollination of ideas among the 50,000 attendees representing different industries.
To register for the event, visit Pharmaexpo.com.
PMMI, The Association for Packaging and Processing Technologies, is a trade association representing over 600 packaging and processing supply chain companies that provide a full range of packaging and processing machinery, materials, components and containers. PMMI actively brings buyers and sellers together through programs and events such as The PACK EXPO family of trade shows, packexpo.com, PMT Magazine, PACK EXPO Show Daily, networking events and educational programs.
PMMI organizes the PACK EXPO trade shows: PACK EXPO International, Pharma EXPO, co-located with PACK EXPO International and presented jointly with the International Society for Pharmaceutical Engineering (ISPE); PACK EXPO Las Vegas, PACK EXPO East, EXPO PACK México and EXPO PACK Guadalajara, connecting participants in the packaging and processing supply chain with their customers around the world. Coming Up: EXPO PACK México 2014, June 17-20 (Mexico City, Mexico); PACK EXPO International 2014, Nov. 2-5 (McCormick Place, Chicago); Pharma EXPO, co-located with PACK EXPO International 2014; PACK EXPO East, debuting Feb. 16-18, 2015 (Pennsylvania Convention Center, Philadelphia); EXPO PACK Guadalajara 2015, March 10–12, 2015 (Guadalajara, Jalisco, Mexico).
ISPE, the International Society for Pharmaceutical Engineering, is the world’s largest not-for-profit association serving its Members through leading scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle. The 20,000 Members of ISPE are building solutions in the development and manufacture of safe and effective pharmaceutical and biologic medicines and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Tampa, Florida, USA and offices in Frankfurt, Germany and Shanghai, China and is publisher of Pharmaceutical Engineering Magazine. Visit www.ISPE.org for more information.
 Zhang, Jinyou, "Manufacture of mammalian cell biopharmaceuticals," Manual of Industrial Microbiology and Biotechnology, 3rd ed., ASM Press, April 2010.
 Source: A.A. Shukla and U. Gottschalk, "Single-use disposable technologies for biopharmaceutical manufacturing," Trends in Biotechnology, Vol. 31 (3), March 2013, p. 147.