Pharmaceutical Technology Editors

Catalent announced on April 6, 2022 that it has acquired Vaccine Manufacturing and Innovation Centre UK Limited’s biologics development and manufacturing facility currently under construction near Oxford, United Kingdom. Catalent plans to invest up to US$160 million (£120 million) into the completion of the construction of the facility.

The focus of the facility will be to develop and manufacture biologic therapies and vaccines, including messenger RNA, proteins, and other advances modalities. The facility is expected to employ more than 400 people once completed as well as support public and private organizations looking to develop and manufacture biotherapeutics.

Catalent’s workforce in the UK already exceeds 1300 people at its four facilities, located in Nottingham, Swindon, Haverhill, and Dartford. The company also has sites in Italy, Belgium, France, Switzerland, and the United States.

“This acquisition allows Catalent to collaborate with the rich academic and biomedical science community centered around Oxford, with its world-class talent, and will result in a facility that provides opportunities to transform innovation into real treatments for patients across the United Kingdom, Europe, and beyond,” commented Mike Riley, president of Catalent Biotherapeutics, in a press release. “Our priority is to complete construction as soon as possible to be able to commence customer programs in 2022. We will then integrate its capabilities within our existing network of biologics facilities across Europe to offer a flexible range of manufacturing, technology, and development solutions for the pipeline of thousands of development programs currently underway.”

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Catalent has acquired the Vaccine Manufacturing Innovation Centre in Harwell, Oxford to expand its biologics capabilities across the UK and Europe.

Catalent Acquires Vaccine Manufacturing Innovation Centre in Harwell, Oxford

PerkinElmer has released two ready-to-use no-wash assay kits in April 2022, the homogeneous time-resolved fluorescence (HTRF) and AlphaLISA. The assay kits are designed to quickly and easily detect and quantify Chinese hamster ovary (CHO) host cell protein (HCP) impurities during the biopharmaceutical manufacturing process, which can prevent immunogenicity and reduce potency, stability, and overall effectiveness of a drug.

According to an April 4, 2022 company press release, HTRF and AlphaLISA are the first kits on the market to be designed for the ready-to-use, homogenous, no-wash assays used in CHO HCP impurity detection. They are also designed to deliver a streamlined workflow, broader dynamic range, and higher sensitivity than traditional multi-step enzyme-linked immunosorbent assays. The kits can be miniaturized to a small sample volume, increasing throughput to 384-well plates.

"The ability to quickly and easily detect, quantify, and subsequently eliminate CHO HCP impurities during biopharmaceuticals manufacturing has continued to be a key challenge," said Alan Fletcher, senior vice-president life sciences, PerkinElmer, in the press release. "These innovative HTRF and AlphaLISA assay kits are designed to make this critical step more effective and efficient within existing workflows and contribute to quality control and successful biotherapeutics."

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PerkinElmer’s HTRF and AlphaLISA assay kits are designed to detect and quantify CHO host cell protein impurities.

PerkinElmer Introduces the HTRF and AlphaLISA Assay Kits

Thermo Fisher Scientific’s newest Raman spectroscopic analyzer, the Thermo Scientific Ramina Process Analyzer, is designed to eliminate much of the complexity inherent to Raman spectroscopy measurements to prioritize user accessibility, the company announced on April 5, 2022.

The Thermo Scientific Ramina Process Analyzer offers non-destructive, continuous analysis without the need for sample preparation. According to Thermo Fisher, it is simpler to install and use compared to traditional Raman process monitoring systems; it can be deployed in as little as 15 minutes and generate spectral data on target analytes within seconds. The system uses a range of patented probes to maximize the speed and sensitivity of results, enabling fully automated 

 measurements to calculate concentrations in a reaction vessel.

The analyzer includes a Raman spectrometer, fiber optic probe, a portable monitor, a mouse, a keyboard, and laser safety goggles. Its solid-state construction is designed to offer long-term stability and continuous accurate measurements without frequent calibration. Multiple systems can be used in parallel to test different reaction vessels simultaneously or combine a number of probes in one vessel.

"We are excited to launch the Ramina Process Analyzer, which offers an almost effortless method of performing precise 

Raman measurements, enabling customers to generate real-time data where and when they need it,” said Chloe Hansen-Toone, vice-president and general manager for field and safety instruments, Thermo Fisher Scientific, in a company press release. “The compact and portable design of this analyzer, as well as its user-friendly operation, will help to reduce time-to-results without the burden of taking up too much valuable laboratory space."

The Thermo Scientific Ramina Process Analyzer is designed with user ease at the forefront.

Thermo Fisher Scientific Launches User-Friendly Raman Spectroscopic Analyzer

Stanley Capital Partners (SCP), a European and US-focused mid-market private equity firm, announced on April 4, 2022 that it has acquired MyMeds&Me (MMM) by its portfolio company Drug Safety and Pharmacovigilance Services Solutions (DSS). DSS is a global pharmacovigilance service under the brand Bioclinica.

MyMeds&Me captures safety data directly from patients, healthcare professionals, and pharma teams through its global SaaS platform, Reportum. MMM’s global client base includes some of the world’s leading pharmaceutical companies.

The digital-first approach will enable DSS to be a foremost provider of pharmacovigilance services, leveraging Reportum for the capture and management of relevant data. The approach will also allow for the accelerated development of the Reportum platform’s capabilities and its integration into the technology landscape.

“The acquisition of MMM will give a further boost to the high-quality service offering we are delivering to our clients, which include some of the world’s largest and most innovative pharmaceutical companies, with the support and investment of SCP,” said Humaira Qureshi, CEO of DSS, in a press release. “The acquisition aligns with the shared strategy of DSS and SCP to secure M&A transactions that grow the technology-enabled platform and broaden the client-focused service offering.”

“MyMeds&Me is proud to be joining the DSS family, providing us with a framework to expand our high-quality technology offering,” said Dr Andrew Rut, CEO and founder of MMM, in a press release. “With the industry’s ever greater focus on patient engagement, the deployment of innovative technology combined with complementary services from DSS will enable our customers to revolutionize their pharmacovigilance strategy and optimize the safe use of their medicines.”
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Stanley Capital has announced the acquisition of MyMeds&Me by its portfolio company Drug Safety and Pharmacovigilance Services Solutions. 

Stanley Capital-Backed Portfolio Company DSS Acquires MyMeds&Me

FDA has accepted the supplemental biologics license application for Priority Review for Dupixent to treat patients 12 years and older with eosinophilic esophagitis (EoE), a chronic and progressive disease that damages the esophagus and impairs the ability to swallow. The target action date for the FDA decision is August 3, 2022.

According to the press release, there are approximately 160,000 patients in the United States living with eosinophilic esophagitis who are currently treated, with 48,000 of them having failed multiple treatments. Dupixent was granted Orphan Drug designation by FDA for the potential treatment of EoE in 2017 as well as Breakthrough Therapy designation in September 2020. Priority review is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis, or prevention of serious conditions.

Individuals with EoE struggle with swallowing, making even small amounts of food painful to swallow and a choking hazard. The disease can cause narrowing of the esophagus, causing the need for dilation of the esophagus, which is often painful. Many individuals rely on a feeding tube as the only option to ensure proper caloric intake and adequate nutrition. Individuals with EoE may experience a poor quality of life and have a greater chance of developing anxiety and depression than those without the disease, according to Sanofi. If approved, Dupixent would be the first medicine available in the US indicated to treat EoE.

FDA has accepted Dupixent for Priority Review in patients aged 12 years and older with eosinophilic esophagitis.

FDA Accepts Dupixent for Priority Review for Patients with Eosinophilic Esophagitis

ATMPS Ltd announced it has been granted a patent from the United States Patent and Trademark Office (USPTO) for Hataali, a blockchain-based data sharing platform used in advanced medicinal therapy products. The company is looking to solidify its technological advantage in the global advanced therapy space and has applications bending in both Europe and Asia.

Hataali possesses an incorruptible data solution that tracks therapies through a complex supply chain and ensures patient safety as well as employs efficient regulatory compliance. This has the potential to create a fully digital solution to the challenges of effectively and safely scaling up production. Without a blockchain-based solution, companies do not have a suitable platform to communicate and coordinate their activities to ensure effective commercialism, according to the company.

The company expects the patent to accelerate the adoption of blockchain technologies. This has the potential to transform the pharma industry by providing a new approach to cell and gene therapy tracking, as well as potentially allowing for more streamlined applications and payment options.

“It’s a big moment for Hataali as it means we have the exclusive use of blockchain—the only technology so far proven to overcome the challenges of effective scale-up—in advanced therapy medicinal products in the United States,” commented Raja Sharif, CEO at Hataali. “Up until now, you have several companies trying to shoehorn in unsuitable old ‘point to point’ technologies as a solution for cell and gene therapy tracking. They have simply not worked, and we expect to take a dominant position over the next few years as it becomes apparent we have the only solution for a cost effective mass roll out of these therapies.”

ATMPS Ltd has been granted a patent from the United States Patent and Trademark Office for the use of its Hataali blockchain technology used in personalized medicines.