Pharmaceutical Technology Editors

Bio-Rad Laboratories recently expanded its portfolio of recombinant monoclonal anti-idiotypic antibodies to include antibodies that are specific to Adcetris (brentuximab vedotin), Cosentyx (secukinumab), and the secukinumab-interleukin 17A (IL-17A) drug-target complex.

Brentuximab vedotin is an antibody drug conjugate used to treat Hodgkin lymphoma, while secukinumab is used to inhibit inflammatory response in several diseases, such as ankylosing spondylitis, psoriasis, and psoriatic arthritis.

According to a company press release from July 12, 2022, these antibodies can be used in the bioanalysis and drug monitoring of brentuximab vedotin, secukinumab, and their biosimilars.

The antibodies for antibrentuximab vedotin and antisecukinumab are approved for 

 testing services to support drug and biosimilar development, and patient monitoring.

Articles

Bio-Rad has expanded its range of recombinant monoclonal anti-idiotypic antibodies.

Bio-Rad Expands Portfolio of Anti-Idiotypic Antibodies

Oregon Freeze Dry (OFD), a lyophilization and freeze-drying company, opened a new biopharmaceutical development and clinical facility in Albany, Ore., on July 25, 2022. According to a company press release, the $7.5 million facility is designed to support the development of traditional pharmaceutical active ingredients, combination products, and medical devices, as well as support lyophilization process development.

The Albany facility will also host lyophilization process development and clinical trials, and features environmental controls that can support development of oral drugs. The Albany facility is OFD’s fifth facility in the United States and is set to add at least six new positions to a staff of more than 450.

“Our new facility supports the vision of a world where vaccines and medications can bypass a syringe and be administered orally, increasing access to life-changing medicine around the world,” said Joe Folds, president and CEO, OFD, in the release. “We’re ready and eager to collaborate with pharmaceutical companies and support advances in microbial therapeutics, immunotherapy, and cell and gene therapy.”

The new facility in Albany, Ore., will support biopharmaceutical development and lyophilization services.

Oregon Freeze Dry Opens $7.5 Million Biopharma Facility

The Novasep-PharmaZell Group has announced a €7.3M (approximately $7.45 USD) investment for its Mourenx, France site as part of a larger project supported by the French government’s “France Relance” Plan, to create a multipurpose pilot workshop within one of its production units. The new industrial tool will support the growth of the Mourenx site and sustain the growing demand for production of active pharmaceutical ingredients (APIs), specifically the highly potent drugs (HPAPIs) used to treat cancer.

According to a company press release, the investment includes an upgrade of two existing 2000-liter reactors, a new 1500-liter reactor, and a Hastelloy filter-dryer. This aligns with the company’s ongoing efforts to modernize equipment and product APIs for targeted therapies, focusing on HPAPIs.

"This major project to modernize and expand the Mourenx site demonstrates our new Group's determination to pursue the strategy of industrial investments that we have been successfully deploying for several years,” said Jean Bléhaut, president of the CDMO Business Unit, in the release. "This is a clear and practical answer for our pharmaceutical customers, who face growing challenges to secure supply chains in the field of healthcare products, and particularly APIs.”

"Creating this unit is an opportunity to diversify the Mourenx site's activity with a new state‐of‐the‐art production tool that improves our capacity for handling highly potent therapeutic products,” added Patrick Suescun, Mourenx Site Director. "This will clearly be beneficial to our clients and their patients, as well as to our local teams, who will be working with the best equipment to fulfill our commitments."

Novasep-PharmaZell will increase API production capacity at its Mourenx site with €7.3M investment. 

Novasep-PharmaZell Invests €7.3M to Increase API Production Capacity

The ROSS PDDM Planetary Dual Disperser is a robust mixer that offers a high degree of shear intensity and rapid dispersion of dry powders into viscous batches. This system allows solid additions to be made quickly and efficiently via two stainless steel high viscosity (HV) stirrer blades and two high-speed shafts with saw-tooth dispersers.

When equipped with removable disperser shafts, the PDDM can be used as a regular double planetary mixer for processing even more viscous applications. This includes very stiff, dough-like formulations that rely more on a purely kneading action. Sizes range from lab scale to full production models.

The ROSS PDDM Planetary Dual Disperser offers flexibility in the form of removable disperser shafts. 

Planetary Dual Dispersers for Viscous Batches

PerkinElmer’s GC 2400 Platform is an automated gas chromatography (GC), headspace sample, and GC/mass spectrometry solution designed to simplify lab operations, drive precise results, and perform flexible monitoring.

The GC automated sampling is designed to reduce hands-on time and human error in high throughput lab environments and complex applications. Additionally, its unique automated headspace/pneumatics technology is intended to significantly improve precision.

The device can monitor multiple GC 2400 systems via a wireless, customizable touchscreen table interface. Built-in sensors and a software-driven gas saver mode reduce operational gas consumption and support carrier gas alternatives such as hydrogen.

PerkinElmer’s GC 2400 Platform is designed to perform various sampling tasks related to gas chromatography and headspace sampling.

Multipurpose Lab Sampler

Telstar’s Smart Format system is designed for the transportation of vials using a mobile platform that is configured to fit a wide range of vial sizes in the freeze-drying loading and unloading process. It presents an alternative to manually changing multiple vial formats, instead automatically adapting to vial diameter without disrupting the isolation process.

The system is made up of different modules that interact and connect various blocks of transition, straight sections, and corners that can be combined in any way to form a complete loading and unloading line. It does this via a mechanism that transforms rotary movement into a linear motion while actuators and the guiding system are mounted below the conveyor structure.

The Smart Format is designed to be easy to clean and sterilize. It has a setting range between 2R and 100R.

Telstar’s Smart Format system automatically transports vials of different formats.