New Equipment Advances Biopharmaceutical Operations

fotogenicstudio/shutterstock.com

Over the past several months, manufacturers have introduced new and updated products to improve biopharmaceutical operations. The following is a sampling of some of these new product options.

Single-use system enables process and product protection

Parker Bioscience’s SciLog SciPure FD System is an automated single-use system for the filtration and dispensing of products into either bottles or bags (1). 

The new system offers process protection at the bulk pack-off stage of API production by combining the fully automated bulk filtration and dispensing of biopharmaceutical products with a shipping solution that ensures product integrity. Additionally, the system’s hardware and consumables have been developed in tandem to minimize product losses and maximize yield.

The company’s fully validated shipping solution complements and extends the capabilities of the SciLog SciPure FD System. The company states that it has created a patent-pending bottle design that offers manufacturers the confidence that bulk drug products will arrive at their final destinations without contamination. The bottle integrity has been validated down to -89 ˚C while undergoing a validated ASTM D4169 shipping study for performance testing of shipping containers and systems.design that offers manufacturers the confidence that bulk drug products will arrive at their final destinations without contamination. The bottle integrity has been validated down to -89 ˚C while undergoing a validated ASTM D4169 shipping study for performance testing of shipping containers and systems.

New perfusion-enabled bioreactors

On Sept. 4, 2018, Sartorius Stedim Biotech (SSB) and Repligen Corporation announced a collaboration agreement to integrate Repligen’s XCell ATF cell-retention control technology into SSB’s BIOSTAT STR large-scale, single-use bioreactors to create next-generation perfusion-enabled bioreactors (2). 

A single control system for 50–2000 L bioreactors used in perfusion cell-culture applications is designed to control cell growth, fluid management, and cell retention in continuous and intensified bioprocessing and simplify the development and cGMP manufacture of biological drugs.

Additionally, the companies will also collaborate to equip SSB’s recently launched ambr 250 high throughput (ht) perfusion single-use mini bioreactor system with Repligen’s KrosFlo hollow-fiber filter technology. The bioreactor system will be sold by SSB as a complete single-use assembly. 

This design conserves hollow-fiber filter technology across scales, enabling users to fast-track development and scale up their cell-culture perfusion processes, SSB reports. The bioreactor system will be sold by SSB as a complete single-use assembly. This design conserves hollow-fiber filter technology across scales, enabling users to fast-track development and scale up their cell-culture perfusion processes, SSB reports.

Mini microcarrier bioreactor for culturing adherent cells

Also from SSB comes a new mini bioreactor vessel for its ambr 250 ht system (3). The new single-use vessel is based on cell-culture bioreactors in the ambr 250 ht system and designed for optimal growth of adherent cells on microcarriers, enabling the rapid, scalable cell-culture process development of vaccines, the company reports. 

The mini bioreactor has a working volume of 100–250 mL and features a single Elephant Ear impeller. This impeller type generates improved mixing and suspension of microcarriers, allowing adherent cells to grow over the entire microcarrier surface. Using this bioreactor on the ambr 250 ht system allows rapid scale-up of optimized adherent cell culture processes to the company’s BIOSTAT STR range of pilot- and manufacturing-scale stirred bioreactors. 

The company claims that this result in shorter process development timelines than would be achieved by scientists using benchtop bioreactors and spinner flasks. The mini bioreactor reduces set-up and turnaround time and is suitable for design-of-experiments studies, as stated by SSB.

Updated purifier product for clarification

3M added new features to its Emphaze AEX Hybrid Purifier that include sterilization/sanitization compatibility and additional sizes (4).

The new Emphaze capsules are sterilization/sanitization compatible and can be used across various aqueous-based biopharmaceutical processes, including vaccine purification and now include two new laboratory-scale capsules and one scale-up capsule, allowing for evaluations at laboratory and scale-up volumes.

Emphaze AEX Hybrid Purifier products are synthetic multi-mechanism single-use purifier products used for biopharmaceutical clarification. They deliver consistent, high-purity clarified process fluid by removing soluble and insoluble impurities, such as DNA, host cell protein (HCP), and cell debris, through a combination of chromatographic and size-exclusion mechanisms. The product combines three 3M technologies-advanced polymer materials, fine fiber nonwovens, and membranes-to deliver a synthetic clarifying product line containing a novel anion exchange nonwoven media and a fine particle, reduction membrane.

“Customer input is critical in evaluating the performance and effectiveness of any product to maximize performance,” said Himanshu Nivsarkar, global marketing manager, 3M Separation and Purification Sciences Division, in a company press release. 

“With the Emphaze AEX Hybrid Purifier, customers experience benefits in typical monoclonal antibody purification processes, including nominal 30% HCP and greater-than-4-log DNA reduction. It has a consistent output turbidity (<5 nephelometric turbidity unit) leading to potential downsizing of the sterilizing grade membrane and increased product purity post-protein A. This also reduces turbidity post viral inactivation/neutralization step leading to a lower impurities on the downstream AEX column, thus allowing customers to optimize their processes.”

Detachable AODD pump

Wilden, part of PSG, a Dover company, released its new 6 mm (1/4”) Velocity Series air-operated double-diaphragm (AODD) pump (5). The V2550 Velocity Series pump features a detachable mounting foot, providing adaptable mounting capabilities suitable for all small-dosing applications.

The company reports that the pump can be reoriented by loosening a single screw. The design provides the user with multiple mounting options while allowing the pump to fit into restricted spaces, a critical consideration for original equipment manufacturer systems and skids. 

The pump’s design also eliminates the effects of torque decay and delivers improved dry suction lift at all operating parameters for better priming under a variety of system conditions.  Additionally, the pumps feature an interchangeable footprint with competitor and previous company designs. This pump series comes equipped with a simple air distribution system (ADS) with two moving parts that reduce the risk of downtime, according to the company. Wilden Velocity Series pumps can handle suction lifts from 10–14 feet. These pumps are available in polypropylene and PVDF construction, as well as an Accu-Flo (solenoid) option (5). 

References

1. Parker Bioscience, “Parker Bioscience Launches New System to Support Process and Product Protection,” Press Release, June 12, 2018.
2. Sartorius Stedim Biotech “Sartorius Stedim Biotech and Repligen Corporation Partner to Introduce Next-Generation Perfusion-Enabled Bioreactors,” Press Release, Sept. 4, 2018.
3. Sartorius Stedim Biotech, “Sartorius Stedim Biotech Introduces Mini Microcarrier Bioreactor for Culturing Adherent Cells,” Press Release, April. 19, 2018. 
4. 3M, “3M Enhances the Emphaze AEX Hybrid Purifier,” Press Release, Sept. 5, 2018. 
5. Wilden, “Wilden Launches Velocity Series AODD Pumps,” Press Release, July 30, 2018.

Article Details

BioPharm International
Vol. 31, No. 11
November 2018
Pages: 39–40

Citation

When referring to this article, please cite it as A. Lowry, " New Equipment Advances Biopharmaceutical Operations," BioPharm International 31 (11) 2018.