With an aging population, the resultant increase in prevalence of chronic diseases, and more demand from patients for dosing convenience, the biopharma industry has seen an exponential increase in adoption of biological therapies delivered in prefilled syringes. The overall prefilled syringes market is forecasted to be worth nearly $10 billion by the year 2025, according to market research (1), driven in part by the rise in use of biological drugs. This article discusses the challenges, safety considerations, and emerging trends in the field of pre-filled syringes for biologics.

Pharmaceutical Technology Biologics and Sterile Drug Manufacturing


	eBook: Biologics and Sterile Drug Manufacturing, May 2020
	May 2020
	Pages: 20–23

	When referring to this article, please cite it as F. Thomas, "On Point: Biologics Drive Growth in Pre-Filled Syringes," 

Pharmaceutical Technology Biologics and Sterile Drug Manufacturing eBook 

Articles

Manufacturing

As a result of the rising use and development of biological drugs, the biopharma industry is witnessing an increase in the adoption of prefilled syringes.


On Point: Biologics Drive Growth in Pre-Filled Syringes

Adoption of single-use technology (SUT) by biopharmaceutical manufacturers has been gaining momentum for many years. Existing automation and instrumentation technologies, however, need to be adapted for optimal compatibility with single-use configurations.

	Suppliers have developed a new category of sensors and fittings to address the needs of SUT processing. These components are based on traditional technologies and use standard signaling means for reliable and accurate measurement, but they have specific performance features so end users can take advantage of their SUT operations. .


	eBook: Biologics and Sterile Drug Manufacturing, May 2020
	May 2020
	Pages: 16–19

	When referring to this article, please cite it as B. Haschke, "Instrumenting Single-Use Processes," 

Single-use processing requires instruments providing the accuracy of traditional technologies but configured in form factors designed specifically for this service

Instrumenting Single-Use Processes

 spoke with Richard Denk, senior consultant aseptic processing and containment, SKAN AG, about the risks of contamination in biopharmaceutical manufacturing and how this risk can be mitigated.


	eBook: Biologics and Sterile Drug Manufacturing, May 2020
	May 2020
	Pages: 38–42

	When referring to this article, please cite it as S. Haigney, “Considerations in Contamination Control,"

 Pharmaceutical Technology Biologics and Sterile Drug Manufacturing eBook 

Operations

A contamination control strategy can prevent contamination in sterile product manufacturing. The right system, equipment, and personnel training are also essential to mitigate risk.

Considerations in Contamination Control

spoke with John Harmer, director, technical sales at Vanrx Pharmasystems about considerations in choosing the best system and equipment for contamination control in pharmaceutical manufacturing.


	eBook: Biologics and Sterile Drug Manufacturing, May 2020
	May 2020
	Page: 41

Pharmaceutical Technology spoke with John Harmer, director, technical sales at Vanrx Pharmasystems about considerations in choosing the best system and equipment for contamination control in pharmaceutical manufacturing.

Best systems and equipment for contamination control

Ensuring the quality of data in process monitoring and control systems starts in process development phases. Maintaining data integrity during scale up and technical transfer phases is crucial. Building quality features into data management systems is a recommended strategy.

	Pharmaceutical Technology
	eBook: Biologics and Sterile Drug Manufacturing, May 2020
	May 2020
	Pages: 4–9

	When referring to this article, please cite it as C. Challener, “Building Data Quality In Generates Quality Data Out,"

Development

Ensuring the quality of data in process monitoring and control systems starts in process development phases. 

Building Data Quality In Generates Quality Data Out

Though cell therapy is a recent innovation, with the first therapies approved by FDA in 2017, the use of human cells has been a standard of care for decades in hematology and oncology. A cell therapy can be derived from a variety of sources, including hematopoietic, skeletal muscle, neural, and mesenchymal stem cells (i.e., adult stem cells that differentiate into structures such as connective tissues, blood, lymphatics, bone, and cartilage). Given the urgency of ensuring good patient outcomes, it is essential to have a strategy in place for preventing contamination of source cells, as well as the resulting cell therapies.

	When referring to this article, please cite it as F. Mirasol, “Detecting Contamination in Cell Therapies," 

Pharmaceutical Technology Biologics and Sterile Drug Manufacturing

Quality

A variety of assays should be used to detect bacterial, fungal, and viral contaminants in the human source cells used for cell therapies.

Detecting Contamination in Cell Therapies

Viral gene therapy has gained momentum after recent approvals and commercial successes with novel therapies based on chimeric antigen receptor T cell (CAR-T) or direct virus-mediated gene modification. Viral vectors such as adeno-associated viruses (AAV) and lentiviruses are the foundation of such therapies, and their manufacture is not without challenges. With the growing demand for these vectors and the desire to target large organs, higher virus titers are required; higher titers enable the number of batches to be minimized and reduces the cost of manufacturing. The authors here describe the results of a collaboration which focused on identifying best practices during clarification of bulk harvest to ensure maximum virus vector yield. 

	João Marques is senior scientist, and Paul Carter is scientific leader, Downstream Vector; both are at Downstream Process Development at the Cell & Gene Therapy Platform CMC, Medicinal Science and Technology, R&D at GlaxoSmithKline. Matthew Dillingham is a senior process development scientist, Paul Beckett is senior technology manager, Purification Technologies, Adina Paun is account manager pharma processing, Youness Cherradi is senior process development scientist, and Anissa Boumlic

, anissa.boumlic@milliporesigma.com, is associate director Vaccines and Viral Therapies Segment, all at MilliporeSigma.

To whom all correspondence should be addressed.  

	When referring to this article, please cite it as J. Marques et al., “Optimizing Viral Vector Manufacturing for Gene Therapy," 

Synthetic depth filters are a suitable option to provide a high-performance and scalable single-step clarification process.

Optimizing Viral Vector Manufacturing for Gene Therapy

The right approach to biological safety cabinets (BSC), and collaboration between engineers and those who will operate the equipment, is crucial to preventing cell-culture contamination. This article summarizes the key criteria for assessing BSC performance so that it prevents contamination.

's Biologics and Sterile Drug Manufacturing eBook.


	eBook: Biologics and Sterile Drug Manufacturing
	May 2020
	Pages: 34–37

	When referring to this article, please cite it as D. Phillips, "Minimizing Contamination During Biopharma R&D," 

Pharmaceutical Technology Biologics and Sterile Drug Manufacturing eBook

The right approach to biological safety cabinets, and collaboration between engineers and those who will operate the equipment, is crucial to preventing cell-culture contamination.

Minimizing Contamination During Biopharma R&D

Regulators have exaggerated expectations for simulated media fills.

	This article reviews aspects of media fill execution in which regulatory expectations have created artificial compliance concerns and significant practical difficulties.


	eBook: Biologics and Sterile Drug Manufacturing
	May 2020
	Pages: 10–14, 43

	When referring to this article, please cite it as J. Agalloco, "Complications in Process Simulation Execution," 

Regulators have exaggerated expectations for simulated media fills. 

Pharmaceutical Technology-05-15-2020

On Point: Biologics Drive Growth in Pre-Filled Syringes

Instrumenting Single-Use Processes

Considerations in Contamination Control

Best systems and equipment for contamination control

Building Data Quality In Generates Quality Data Out

Detecting Contamination in Cell Therapies

Optimizing Viral Vector Manufacturing for Gene Therapy

Minimizing Contamination During Biopharma R&D

Complications in Process Simulation Execution