Microbial contamination poses a risk to patients—especially in the case of drug products administered parenterally—and must be addressed through quality control measures in manufacturing to ensure product safety. Parenteral products are injected directly into the body, bypassing the gastrointestinal tract, one of the body’s natural defences. Therefore, these treatments must be manufactured under strict sterile processing conditions. This sterile process aims to significantly minimize the presence of particulate and microbial contamination that could have detrimental effects on patient health.

Sensitive products, such as advanced therapy medicinal products (ATMPs)—including gene therapies, cell-based therapies, and tissue-engineered products—often rely on parenteral delivery, as they degrade within harsh acidic environments such as those found within the stomach. With projected growth from $10.37 billion in 2023 to $23.58 billion in 2028, the ATMP market is expected to increase at a compound annual growth rate (CAGR) of 13.2% (1). This market value increase reflects the growing interest in these treatments that address unmet needs, with a particular focus on curative solutions for chronic diseases. Their reliance on sterility for safety demands robust aseptic processing methods, the market for which, as a result, is also growing rapidly, with an expected CAGR of 6.13%, from $95.63 billion in 2023 to $173.37 billion in 2033 (2).

One solution aiming to reduce the risk of microbial contamination works by introducing closed manufacturing methods, which can be achieved with single-use technologies (SUTs). This means that the product is closed off from the outside environment and transferred between sterile systems.

November 2023 Manufacturing and Facilities eBook

head of Product Management and Marketing, ChargePoint Technologies

When referring to this article, please cite it as Wylie, B. De-Risking Sterile Manufacture with SUTs. 

BioPharm International’s Manufacturing and Facilities eBook 

Articles

Single-use technologies provide a barrier between operators and drug products, allowing for sterility and personnel safety in manufacturing.

De-Risking Sterile Pharma Manufacture with SUTs

As the biopharmaceutical industry moves into the end of 2023, biopharmaceutical companies should take stock of the latest developments in biopharmaceutical manufacturing and facilities. Over the past few months, manufacturing has seen many facility expansions and openings throughout the globe, partnerships for outsourcing services, and various acquisitions and expansions of manufacturing companies.

When referring to this article, please cite it as Husni, D. Update on Facilities and Manufacturing Trends. 

Manufacturing

A look into the latest developments in biopharmaceutical manufacturing and facilities.


Update on Facilities and Manufacturing Trends

Biologic manufacturing has seen numerous developments that have helped reduce production process timelines, with the industry striving to standardize and simplify manufacturing processes. By developing comprehensive strategies that include deep knowledge of the regulatory arena, specialized contract development and manufacturing organizations (CDMOs) can streamline workflows, reduce production costs, and increase efficiency. As growing numbers of biotechs seek support from expert CDMOs, efforts must be made to further streamline timelines with a sharp focus on the technology transfer process.

Jinhyeok Jeong is senior director of Drug Product Inspection and Packaging, and John Thomas is senior director of Drug Product MSAT; both at Samsung Biologics.

When referring to this article, please cite it as Jeong, J.; Thomas, J. Tech Transfer and Regulatory Compliance. 

Demand for efficient tech transfer, as well as compliant on-time delivery, is rising.

Tech Transfer and Regulatory Compliance

In speaking with Suzanne Aldington, senior principal scientist, Downstream Processing, Biologics, and Lucas Lin, senior principal scientist, Global Process Development Implementation, Biologics, both at Lonza, 

® took a pulse on the supply chain lifeline for biologics in the post-pandemic setting. Discussion revolved around any impact the current state of the supply chain may be imparting on scale-up activities in downstream bioprocessing.

Feliza Mirasol is the science editor for 

When referring to this article, please cite it as Mirasol, F. A Look at Supply Chain for Scale Up. 

Taking a brief status check on the biologics supply chain and any impact on scale up operations.

A Look at Supply Chain for Scale Up

Environmental concerns impact a variety of industries, including bio/pharmaceutical companies. 

Jeff Wegner, Fellow—Energy and Sustainability at CRB

, to find out how bio/pharma manufacturers can achieve sustainability and zero-carbon initiatives.

Susan Haigney is managing editor, and Alivia Leon was previously assistant editor, both with 

When referring to this article, please cite it as Haigney, S. and Leon, A. Sustainability Using Zero-Carbon Biopharma Facilities. 

How can sustainability and zero-carbon initiatives be achieved?

Sustainability Using Zero-Carbon Biopharma Facilities

The oligonucleotide industry continues to grow at a rapid pace. Given the relatively small quantities of drug substance produced compared to, for example, products at an industrial chemical manufacturing facility, one might assume only limited volumes of solvents would be required. However, solid-phase oligonucleotide synthesis (SPOS) and downstream processing of oligos uses significant quantities of hazardous materials. It takes roughly 3000–7000 L of flammable liquids to produce 1 kg of drug substance.

As oligo manufacturers scale up production from lab-scale to clinical and commercial scales to meet industry demand, they are likely to require volumes of hazardous materials that drive additional facility design considerations for code and regulatory compliance.

Kyle Hubbard is process engineer at CRB; Bill Jarvis is senior fellow, Pharmaceutical Process, at CRB.

When referring to this article, please cite it as Hubbard, K. and Jarvis, B. Oligonucleotide Production Facilities. 

As oligo manufacturers scale up production from lab-scale to clinical and commercial scales, they may require volumes of hazardous materials that drive additional facility design considerations. 

Manufacturing and Facilities, November 2023 eBook

De-Risking Sterile Pharma Manufacture with SUTs

Update on Facilities and Manufacturing Trends

Tech Transfer and Regulatory Compliance

A Look at Supply Chain for Scale Up

Sustainability Using Zero-Carbon Biopharma Facilities

Oligonucleotide Production Facilities