Pharmaceutical Technology Editors

Akadeum Life Sciences’ Microbubble Leukopak Human T-Cell Isolation Kit

Akadeum Life Sciences’ Microbubble Leukopak Human T-Cell Isolation kit is a research-use-only kit developed to address various biological and workflow challenges in large-volume cell separation workflows. The kit uses a technology combining microbubbles with a buoyancy-activated cell sorting separation tube to produce nearly two leukopaks,which are blood bags containing billions of white blood cells, in one hour.

Akadeum’s patented microbubble technology uses low-density particles to float targeted cells to the top of a sample. In addition to reducing the time necessary to produce leukopaks, the technology is also designed to promote the health and physiology of the
cells, allow for minimal handling, increase throughput, and enable less pre-processing.

Articles

Akadeum’s Life Sciences isolation kit uses microbubbles to reduce leukopak production time.

Microbubble-Enabled Isolation Kit

Evoqua’s Water Technologies Sophis digital services is a water treatment service designed for the pharmaceutical industry. The product uses smart technology, data analytics, engineering expertise, and proactive service to manage the product life cycle for peak performance, with the aim of ensuring reliable, high-purity water.

The service uses predictive analytics to reduce risk and provide early identification of process anomalies—before they can impact production—through non-stop remote monitoring of critical system operating parameters, real-time data analytics, and service support. Expert engineering analysis is used to determine corrective actions, along with proactive service for on-site resolution. Evoqua subject matter experts analyze operational system data on an ongoing basis to promote optimal performance.

The service is currently available with Evoqua’s VRx and SDRx pharmaceutical water systems. Both of these systems are designed to produce and distribute compendial purified water and water for injection in accordance with 

Evoqua’s Sophis digital services is a holistic monitoring and analysis solution for pharmaceutical water management.

Real-Time Water Monitoring System

Lonza and Singzyme, a biotechnology company specializing in developing enzymes for protein ligation, announced a strategic collaboration on Oct. 31, 2022. The goal of this partnership is for the companies to use Singzyme’s enzymatic conjugation platform to develop novel bioconjugates.

The partnership will grant Lonza access to Singzyme’s enzymatic conjugation platform, which is designed to enable the site-specific binding of payloads with peptidic linkers to proteins of interest. In return, Singzyme will gain access to Lonza’s network and expertise in the development and manufacture of bioconjugates.

“Singzyme’s highly-specific conjugation platform represents an attractive addition to Lonza’s Bioconjugation toolbox that includes protein expression, linker and payload manufacturing, manufacturability assessments, de-risking, and bioconjugation,” said Stefan Egli, vice-president and head of Bioconjugates, Lonza, in the release. “Its implementation into our offering will further increase our bioconjugation repertoire and provide reliable and selective conjugation solutions for our customers aiming to develop novel bioconjugates.”

“The collaboration between Lonza and Singzyme will provide Lonza’s customers with access to a one-stop technology platform allowing for rapid site-specific bioconjugation including dual payloads, with fully controllable drug-to-antibody ratio, while preserving antibody activity,” said Abbas El Sahili, chief technology officer, Singzyme, in the release. “We foresee that this collaboration will significantly shorten the [antibody drug conjugate] development timeline and bring a wealth of novel drugs faster to the clinic for the benefit of cancer patients.”

Lonza and Singzyme will use Singzyme’s enzymatic conjugation platform to develop novel bioconjugates.

Lonza and Singzyme Enter Bioconjugates Partnership

Terumo Pharmaceutical Solutions (TPS), a division of Terumo Corporation, announced on Oct. 31, 2022 that it is expanding its contract development and manufacturing services for parenteral drugs to customers outside of Japan. The contract and development manufacturing organization (CDMO) offers end-to-end services with pre-filled syringe (PFS) design, molding, drug preparation, filling, assembly, and final packaging for biotech drugs and small molecules.

The expanded services would include early development stage to large-scale commercial production for global pharmaceutical customers, including assembly of PFS with devices such as autoinjectors and needle safety devices. The company would also offer customers global regulatory submissions support.

“I am excited for what the future holds for Terumo as we are in a unique position being able to offer an integrated solution of primary container, fill and finish capability, and device assembly, in addition to our traditional offering of injection, primary container, and infusion therapy devices,” said Marco Chiadò Piat, president of Terumo Pharmaceutical Solutions, in a press release.

Terumo will be showcasing the new global CDMO service at CPHI Frankfurt from Nov. 1–3, 2022.

The company is expanding its contract development and manufacturing services for parenteral drugs to global customers.

Terumo Pharmaceutical Solutions Expands CDMO Services

Announced at CPHI Frankfurt, the CPHI Annual Survey – which features insights from 400 global pharma companies – revealed that global pharma confidence in growth, innovation, and manufacturing quality has reached record highs.The overall CPHI Pharma Index, a collateralized metric of all major ranking categories, has risen by more than 8%, the largest year-on-year gain in the survey’s six year history.

According to the results, the United States remained at the top of the pharma industry rankings, while Germany remained in second and the United Kingdom knocked Japan off the podium; both of these countries posted double-digit growth. Notably, the range of scores continued to decrease this year, which might suggest a narrowing between industry powerhouses and emerging pharma nations.

India had the most significant score change, ranking alongside leading western nations for the first time; the country also retained its high score for growth potential. India also continued to improve in terms of “API Quality”, with a 15% improvement, second only to China’s 25% improvement in this sector. India is now level with both Switzerland and Japan in this category, while China rivals France and Italy.

“These findings are incredibly positive for pharma manufacturers and demonstrate that the industry believes they have made great strides to further improve quality,” said Adam Anderson, executive vice-president, Informa Markets, in an agency press release. “It’s also very encouraging that, as we open CPHI Frankfurt, we see such optimism for pharmaceutical production next year, with the industry bucking wider macroeconomic headwinds. The partnerships established this week at CPHI Frankfurt will be invaluable in helping deliver on this potential and I encourage the industry not only to meet in person, but to also use all the post-event digital partnering tools available.”

Metrics from the CPHI Annual Survey suggest that confidence in the global pharma market has risen significantly in the past year.

CPHI Pharma Index Indicates Record High for Global Pharma Confidence

Purolite, an Ecolab company and manufacturer of synthetic and agarose-based resins, announced that it had expanded and extended its ligand supply agreement with Repligen, a life sciences company who owns two facilities that produce the majority Protein A ligands, on Nov. 1, 2022.

The deal, which now runs through 2032, will see the Repligen supply Purolite with five high-performance ligands. According to a company press release, this agreement is designed for Purolite’s increased expansion in the affinity space, allowing them to provide more solutions for purification of monoclonal antibodies (mAbs) and mAb fragments currently unmet by the market.

Purolite’s jetting technology uses a patented manufacturing method that produces agarose resins that are used in the purification of therapeutics like mAbs. The technology is designed to provide precise control over bead size and distribution, allowing for significant lot-to-lot consistency, unique productivity benefits, and improved quality. According to the release, it also significantly reduces lead times and is a greener alternative to traditional manufacturing methods.

The existing partnership has led to the development and commercialization of Praesto Jetted A50 HipH, which combines Purolite’s base beads and Repligen’s ligand technology to provide a novel protein A affinity resin. According to the release, this resin is capable of eluting at milder conditions when compared to conventional protein A resins available on the market.

“We are delighted that Repligen has chosen to extend and further strengthen its agreement with Purolite to continue to commercialize their affinity ligands which are specifically designed to target antibodies and fragments combined with our innovative Praesto agarose jetting base bead technology,” said Hayley Crowe, senior vice-president and general manager, Purolite, in the release. “We look forward to continuing a productive relationship with Repligen and adding this ligand technology to our suite of products.”

Purolite and Repligen have extended their existing ligand partnership through 2032.