The implementation of single-use systems (SUS) for biopharmaceutical manufacturing as an alternative to or in combination with traditional stainless-steel equipment offers advantages. In a fully disposable or hybrid facility, however, because pieces of equipment (e.g., reactors, transfer tubing, holding vessels) are now consumables, the supply to the manufacturing facility is more complex. The demand for customized systems and the overall growth of demand for SUS add to the pressure to improve supply.

Biologics and Sterile Drug Manufacturing 2019

	When referring to this article, please cite it as J. Markarian, “Supply Chain Challenges for Single-Use Systems," 

Biologics and Sterile Drug Manufacturing 

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Suppliers address the complexity of supplying disposable components for single-use systems to the global biopharmaceutical manufacturing industry.

Supply Chain Challenges for Single-Use Systems

Commercialization rights for novel therapeutic products are protected for a finite period by patents and other measures. After expiration of patents and other exclusivity rights, other manufacturers are allowed to make copies of these products, referred to as generics in the case of small-molecule pharmaceuticals and biosimilars in the case of biopharmaceuticals. Biosimilars are biological products that are highly similar to and have no clinically meaningful differences from an existing approved reference product. They offer improved affordability and are thus expected to have major impact on accessibility of biotherapeutics, including in developing and emerging economies. The global market value of biosimilars is expected to reach $36 billion by 2020.

	This article presents some key differences between the US and European regulation of biosimilars, including naming conventions and pharmacovigilance of biosimilars, and the impact of biosimilars on commercialization and affordability of biotherapeutics.

	When referring to this article, please cite it as A. Rathore et al., "Challenges with Successful Commercialization of Biosimilars," 

Pharmaceutical Technology Biologics and Sterile Drug Manufacturing 

This article presents some key differences between the US and European regulation of biosimilars, including naming conventions and pharmacovigilance of biosimilars, and the impact of biosimilars on commercialization and affordability of biotherapeutics.

Challenges with Successful Commercialization of Biosimilars

Silicone oil has been widely used to coat the components of container/closure systems for biopharmaceutical products, including syringe barrels and plungers for prefilled syringes and stoppers for glass vials. Drug product formulations are therefore typically in direct contact with the silicone oil coating over long periods of time, causing concern that the silicone oil may leach into the formulations, which may affect the drug product’s purity and efficacy.

	When referring to this article, please cite it as X. Yu et al., "A Study of Leachable Silicone Oil in Simulated Biopharmaceutical Formulations," 

Leachable silicone oil may have an effect on large-molecule APIs, making it important to establish a robust analytical method to detect and quantify the substance.

A Study of Leachable Silicone Oil in Simulated Biopharmaceutical Formulations

Before syringes are used on patients, they must go through rigorous quality control testing. Empty syringes must be tested at the site where filling will be completed as part of an incoming quality control protocol. Filled syringes are subjected to release testing.

	Prefilled syringes can help reduce medication errors; however, the devices pose challenges in manufacturing and require extensive testing.

	Knowledge and understanding of the various tests involved is essential for ensuring patient safety. A holistic approach to syringe manufacturing that includes formulation, process, packaging, device integration, quality control, and an understanding of the user needs is essential.

	When referring to this article, please cite it as C. Challener, "Test Methods and Quality Control for Prefilled Syringes," 

Empty and prefilled syringes must pass a range of quality control tests.

Test Methods and Quality Control for Prefilled Syringes

As Albert Einstein once wrote, “not everything that counts can be counted, and not everything that can be counted counts.” Current regulations seem to demand that instruments prove that a contaminant is not present, when all they can show is that it has not been detected.  As the authors write, only strong validation, process control, quality management and training programs can help ensure that regulations are met or surpassed.

	When referring to this article, please cite it as R. Madsen and J. Agalloco, “Unknown and Unknowable," 

Pharmaceutical Technology Biologics and Sterile Drug Manufacturing 

Quality cannot be verified through testing, especially at the limit of detection, and no test method can confirm the absence of a microbe or particle.

Unknown and Unknowable

Cleanroom monitoring and classification are vital to operations but are still separate functions. This article discusses the differences between the two concepts and emphasizes the need for the two to remain independent. As they write, “A one-size-fits-all approach to cleanroom monitoring will not reflect the diversity of practices” within the industry. In addition, they write, classification values should not be used as monitoring targets.

	When referring to this article, please cite it as J. Agalloco, R. Madsen, and J. Akers, “Distinguishing Between Cleanroom Classification and Monitoring," 

A one-size-fits-all approach to monitoring practices and results is never appropriate, given the diversity of practice within the pharmaceutical industry.

Distinguishing Between Cleanroom Classification and Monitoring

Now that the first cell and gene therapies have become commercial realities and more companies are involved in precision medicine research, different manufacturing platforms are being developed. However, as the authors write, developers need to consider the fundamental differences between these therapies and more traditional biopharmaceuticals to develop the right commercialization strategies.

	When referring to this article, please cite it as W. Colasante, P. Diesel, and L. Gerlovin, “The Link Between Manufacturing and Commercialization in Gene and Cell Therapies," 

The highly customized nature of cell and gene therapy production means that manufacturing innovations for one therapy may not be easily transferable to others.