Pharmaceutical Technology Editors

Avantor announced on Jan. 9, 2023 that it has entered into a multi-year supply and services agreement with Catalent. Under the agreement, Avantor will become the primary supplier of a broad range of laboratory supplies, clinical and productions materials, and services to Catalent. The agreement will expand the companies’ existing relationship and offer more choices to customers.

"We have seen firsthand that Avantor is a terrific partner that brings diverse capabilities and expertise across modalities and geographies, which is essential to meeting global health needs," said Alessandro Maselli, president and CEO, Catalent. "We look forward to deepening our work with the Avantor team to bring current and novel treatments to patients around the world."

"Catalent has built tremendous global capabilities and a reputation as a trusted collaborator to pharma, biotech, and consumer health partners throughout the development and production lifecycle," said Michael Stubblefield, president and CEO, Avantor. "We are pleased to expand our support for Catalent and enable efficiencies to accelerate science for their customers around the globe."

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Avantor and Catalent have entered into a multi-year supply and services agreement. 

Avantor and Catalent Enter Multi-Year Agreement

Agilent Technologies announced the acquisition of Avida Biomed, an early stage life sciences company, on Jan. 4, 2022. This acquisition grants Agilent access to Avida’s high-performance enrichment workflows, which are designed to enable clinical researchers to use next-generation sequencing (NGS) approaches for studying cancer. The financial details of the acquisition were not disclosed in the company press release.

According to the release, this acquisition will complement Agilent’s existing portfolio and help the company expand into high-growth clinical research and diagnostics markets. The chemistries and assays from Avida are compatible with Agilent’s existing automation platforms, facilitating efficient scaling of research experiments and routine sample testing.

Additionally, Avida’s genomics tools enable simultaneous genomic and DNA methylation profiling from a single sample, according to the release; similarly, its streamlined assay protocols, which includes library preparation, can be completed in a single shift. The automatable workflow has also been validated for use with various sample types, including liquid biopsy.

“We are thrilled to welcome the Avida Biomed team to Agilent. We’re also very excited to be able to bring these powerful tools to our oncology customers around the world who are working to improve the understanding of cancer and the diagnosis and treatment of cancer patients,” said Sam Raha, president, Diagnostics and Genomics Group, Agilent, in the release.

“Target enrichment is key to conducting an in-depth analysis of gene targets of interest. We look forward to combining our resources and expertise to make our tools and techniques widely available to clinical researchers across the globe,” said Shengrong Lin, CEO, Avida Biomed, in the release.

Agilent’s acquisition of Avida grants them access to high-performance enrichment workflows that enable NGS approaches for studying cancer.

Agilent Acquires Life Sciences Company Avida Biomed

Merck, known as MSD outside of the United States and Canada, and Kelun-Biotech, a China-based clinical-stage biotechnology company that is a holding subsidiary of Sichuan Kelun Pharmaceutical, recently announced an exclusive license and collaboration agreement. Under the agreement, worth up to approximately $9.3 billion, companies will work together to develop seven investigational preclinical antibody-drug conjugates (ADCs) for the treatment of cancer.

According to a Dec. 22, 2022 press release, Merck will receive exclusive global licenses to research, develop, manufacture, and commercialize preclinical ADC therapies, as well as receive exclusive options to obtain additional ADC candidate licenses. Kelun-Biotech will receive $175 million in upfront payments and an undisclosed equity investment. They will also be eligible for up to $9.3 billion plus tiered royalties for any commercialized ADC product, contingent on various development, regulatory and sales milestone, if they do not retain the rights to research, develop, manufacture, and commercialize certain ADCs for mainland China, Hong Kong, and Macau.

“Advances in ADC technologies are yielding a new generation of candidates designed to more precisely target and deliver potent anticancer agents to the tumor site,” said Dean Y. Li, president, Merck Research Laboratories, in the release. “We continue to augment our oncology pipeline and look forward to working with the Kelun-Biotech team to advance these candidates to the patients that need them.”

“The further expansion of our collaboration with Merck provides a strong endorsement for our technology from a leader in the development of cancer treatments,” said Junyou Ge, CEO, Kelun-Biotech, in the release. “We are grateful for our partnership with the Merck scientists.”

Merck, known as MSD outside of the United States and Canada, will pay Kelun-Biotech up to $9l3 billion for seven early-stage oncology treatments.

Merck Licenses Kelun-Biotech ADC’s in Deal Worth $9.3 Billion

The ROSS Model HSM-405SC-25 Inline High Shear Mixer 

The ROSS Model HSM-405SC-25 Inline High Shear Mixer with solids/liquid injection manifold (SLIM) Technology is designed for production floors that require flexibility. The stainless-steel portable skid features a built-in workbench that helps save time and money. It allows the mixer to be used anywhere in a plant, eliminating the need for separate mixers for each vessel or product.

As an external mixer, the Inline SLIM can be piped to the recirculation loop of virtually any size vessel. Featuring sanitary tri-clamp connections, this 3A-compliant machine can be cleaned in place or quickly disassembled for deep cleaning and sanitation. Using the tabletop workbench, operators can open bags and load powders into the hopper that sits on top of the mixer, ensuring a consistent feed and minimizing aeration.

The SLIM is a unique rotor/stator device capable of injecting powders directly into a fast-moving liquid stream without the use of an eductor or pump. Engineered for high-speed and high-volume mixing requirements, this device can wet out powders and create a fine immediate dispersion, greatly reducing the occurrence of floating powders, lumps, and agglomerates.

The ROSS Model HSM-405SC-25 Inline High Shear Mixer with SLIM Technology is a flexible mixing solution. 

Flexible Inline High Shear Mixer

Particle Measuring Systems’ MiniCapt Pro Remote Microbial Air Sampler

Particle Measuring Systems’ MiniCapt Pro Remote Microbial Air Sampler is an air sampler designed to enable remote microbial monitoring for cleanroom professionals. The device, which is fully compliant with the European Union’s Annex One regulatory revisions, can be mounted in tight spaces. This is intended to give users flexible installation options, including a high efficiency particulate air filter-compatible internal pump, various power options, WiFi, and digital input/output capabilities.

The device’s external 316L stainless-steel enclosure is liquid for simple installation, removal, and reprogramming after service. Additionally, the quick-release mounting bracket stores essential sensor data, such as IP address at the point of measurement, to reduce installation time and errors after calibration or servicing.

Particle Measuring Systems’ MiniCapt Pro Remote Microbial Air Sampler is designed for effective remote microbial monitoring for cleanroom professionals. 

Remote Microbial Air Sampler

Dossplorer, from Qdossiers, a Celegance company, is a cloud-based dossier management solution designed to help pharmaceutical companies import product registration dossiers and ready regulatory submissions for electronic common technical documents compliance. The solution is designed to find documents and registrations in seconds and can filter searches as needed. A novel search functionality has also been added to identify and assess where a given substance or manufacturer has been referenced previously.

This solution allows for the retrieval of regulatory information saved in PDFs via full text indexing. Additionally, users can holistically view the data across multiple applications, which is intended to enable fast and informed decision making. Obsolete documents and version history can also be viewed to prevent two versions of the same document from being worked on simultaneously.

Celegance’s Dossplorer can import product registration dossiers and ready regulatory submissions for electronic common technical documents compliance.