Pharmaceutical Technology Editors

Designed to be easy to use with only basic training, the SamuxMP
mass photometer is utilized in adeno-associated virus (AAV)
analytics. The instrument has a mass range tailored for AAV analysis and
provides accurate results in less than five minutes from sample loading to final result. Combined with low-operational costs and a small footprint, the SamuxMP enables routine quantification of empty/full AAV capsid ratios, even in smaller labs, to set a new standard in AAV characterization.

The SamuxMP is designed to overcome the drawbacks of the current analytical methods by enabling users to rapidly and cost- effectively determine empty/full capsid ratios for AAVs of any serotype at the bench using low sample volumes and concentrations with minimal sample preparation. This is intended to enhance productivity and speed up workflows through more frequent analyses in-house, making R&D and process development of gene therapies and AAV-based therapeutics significantly more efficient.

Articles

The SamuxMP enables routine quantification of empty/full AAV capsid ratios

Rapid Mass Photometer

The Sartolab RF|BT 150–1000 Vacuum Filtration Units

Sartorius’ Sartolab RF|BT 150–1000 vacuum filtration units offer faster and higher capacity filtration relative to past units while also allowing for enhanced physical stability for a wide range of sample types.

The modifications to the product’s design include increased membrane surface area to facilitate optimal filtration, an 0.45 μm polyethersulfone membrane in place of the 0.45 μm cellulose acetate membrane to increase flow rate while keeping the same low-protein binding properties, and an optimized center of gravity to increase stability of the units.

The new units can be directly used on the Sartolab Multistation for parallel filtration. Additionally, the new vacuum filtration units are available in three different pore sizes to meet the needs of most applications: 0.1 μm, 0.22 μm, and 0.45 μm.

Sartorius’ Sartolab RF|BT 150–1000 vacuum filtration units provide fast, high-capacity filtration.

High-Capacity Vacuum Filtration Units

Thermo Fisher Scientific’s Triple Wrap Plates are a range of culture media products designed for environmental monitoring in the pharmaceutical industry. They feature 2D barcodes for full traceability and supply chain integrity, secure fit lids, advanced, clear, triple-layer protection, and a unique Vapour-phase Hydrogen Peroxide (VHP) indicator for enhanced sterility and complete clean room and isolator confidence.

In addition to the integrated VHP indicator, the product comes with new polypropylene packaging, which together enable sanitization of containers for enhanced sterility assurance. The plates are available in standard plates for passive and active air sampling applications and 55 mm contact plates for the microbiological testing of surfaces and personnel.

Thermo Fisher Scientific's Triple Wrap Plates possess a unique Vapour-phase Hydrogen Peroxide (VHP) indicator for enhanced sterility and complete clean room and isolator confidence.

Environmental Monitoring Plates

Cytiva announced on Jan. 25, 2022 that it will provide its FlexFactory single-use manufacturing platform to Arranta Bio, a contract development and manufacturing organization (CDMO), for the manufacture of messenger RNA (mRNA) vaccines.

Arranta is adding $10 million to its $100 million investment in its new Watertown, Mass., facility. The additional $10 million will be used to open a dedicated space for mRNA manufacturing, lipid nanoparticle (LNP) formulation, and drug product filling. With the expansion at the Watertown facility, Arranta will have the capability to offer an end-to-end platform for current good manufacturing practice (CGMP) manufacturing of mRNA products. The new space, scheduled to open within six months, will include 

transcription, mRNA purification, LNP formulation, and aseptic filling. The first round of GMP production is expected in the 2022 third quarter.

“Arranta is offering mRNA developers something unique: an integrated suite of complementary services from a single provider. Cytiva’s solutions provide us with the flexibility and modularity to offer our customers tailored manufacturing. With the addition of Cytiva’s robotic aseptic filling solutions, we are truly an end-to-end, single point of contact CDMO, reducing overall complexity, cost, and time to the product innovator,”said Mark Bamforth, executive chair and CEO of Arranta, in a company press release.

Cytiva had acquired the aseptic business from Canada-based Vanrx 

, which completed its biomanufacturing workflow and enables the company to offer solutions from “idea to injection.”

“Our agreement with Arranta marks the first time our full range of solutions will be used in the manufacturing of mRNA. We’ve developed our platform to work for a multitude of modalities beyond the traditional mAbs [monoclonal antibodies], such as cell and gene therapies, plasmid DNA, and now, mRNA. It’s exciting to support this next generation of therapies that will benefit patients globally and deliver on our company mission to advance and accelerate therapeutics,” said Olivier Loeillot, vice-president of Bioprocess at Cytiva, in the press release.

Arranta Bio will use Cytiva’s FlexFactory single-use manufacturing platform to produce mRNA vaccines.

Cytiva Provides Arranta Bio with Single-Use Manufacturing Platform for mRNA Products

On Feb. 1, 2022, Recipharm announced the acquisition of GenIbet, a Portuguese contract development and manufacturing organization specializing in clinical trial manufacturing and the manufacture of novel modalities, including viral vectors, RNA, and microbiome. The acquisition bolsters Recipharm’s biologics offering, specifically drug substance manufacturing of novel advanced therapy medicinal products.

GenIbet currently focuses on the preclinical and Phase I stages and offers process development services, including the development of new production routes not previously established. Under the deal, Genlbet will provide Recipharm with a platform from which to build its capabilities in new biologics modalities.

“This acquisition is an important step for us in growing our biologics business. We look forward to working closely with the GenIbet team, building links across the wider Recipharm organization to make this business a huge success,” said Marc Funk, CEO of Recipharm, in a company press release.

“Combining our experience and expertise with Recipharm’s capabilities and market reach will make a significant difference for customers on an international scale,” said Raquel Fortunato, CEO at GenIbet, in the press release.

Recipharm will build up its biologics service offering with the acquisition of GenIbet.

Recipharm Acquires Portuguese CDMO, GenIbet, Boosting Biologics Offering

Throughout a tumultuous 2021, the pharmaceutical industry has seen continual innovations in operations, technology, and practices in the outsourcing sector.

 BioPharma Outsourcing Innovation supplement examines outsourcing development services, spray draying, capacity challenges, and more.

Pharmaceutical Technology Europe's BioPharma Outsourcing Innovation supplement examines outsourcing development services, spray draying, capacity challenges, and more.