Pharmaceutical Technology Editors

Precision NanoSystems (PNI), a Canadian genetic medicines technology and solutions company, announced on June 1, 2021 that it has been acquired by Danaher Corporation’s Life Sciences platform.

Currently, PNI offers a Genetic Medicine Toolkit, including its GenVoy LNP delivery platform and NanoAssemblr microfluidic-based nanoparticle manufacturing platform, for the development of genetic medicines, the company said in a press release. PNI also plans on developing a new center of manufacturing excellence in Vancouver to enhance its therapeutic and vaccine manufacturing capabilities.

“PNI has advanced a number of exciting innovations, and we’re thrilled to welcome this talented team,” said Emmanuel Ligner, Danaher Group executive, in the press release. “As mRNA has matured as a successful technology in some COVID vaccines, we’re seeing huge potential for this technology to accelerate other therapies. The work done so far by the PNI team will also enable our customers at Cytiva and Pall [also part of Daniher] to take a huge step forward in advancing their science to improve the lives of patients.”

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Currently, PNI offers a Genetic Medicine Toolkit, including its GenVoy LNP delivery platform and NanoAssemblr microfluidic-based nanoparticle manufacturing platform, for the development of genetic medicines.

PNI to be Acquired by Danaher Corporation’s Life Sciences Platform

Avantor announced on June 1, 2021 that it has acquired RIM Bio, a manufacturer of single-use bioprocess bags and assemblies for biopharmaceutical manufacturing applications located in China.

Through the acquisition, Avantor will have access to RIM’s Changzhou, China, facility, making it Avantor’s first single-use production plant in the Africa, Middle East, Asia (AMEA) region, Avantor said in a company press release. Avantor plans to use RIM’s proprietary technologies and lead times to provide single-use customers with differentiated offerings.

"Adding RIM Bio enables Avantor to better serve our customers by expanding our single-use manufacturing, distribution, and cleanroom capabilities to the AMEA region,” said Ger Brophy, executive vice-president, Biopharma Production at Avantor, in the press release. “RIM serves as an anchor for us to build our presence in this key region, as we better position Avantor to capture long-term opportunities in the growing, global bioproduction space."

Through the acquisition, Avantor will have access to RIM’s Changzhou, China, facility, making it Avantor’s first single-use production plant in the AMEA region.

Avantor to Acquire RIM Bio

Lonza and Moderna announced on June 2, 2021 that they are expanding their collaboration to extend the drug substance manufacturing of Moderna’s COVID-19 vaccine with the addition of a new manufacturing line at Lonza’s Geleen, Netherlands, site.

The new line, which is expected to be fully operational by the end of 2021, complements Lonza’s existing drug substance production network while providing an additional 300 million doses per year, at a 50 ug dose, Lonza said in a company press release.

The new addition comes after the companies 

 a 10-year strategic collaboration agreement for the manufacturing of Moderna’s COVID-19 vaccine in May 2020.

“Once more, we are pleased to leverage our network as we expand our collaboration with Moderna further to extend our mRNA [messenger RNA] manufacturing to Lonza Geleen,” said Jean-Christophe Hyvert, president, Biologics and Cell & Gene, Lonza, in the press release. “The extension reflects the continuing growth of our strategic collaboration with Moderna. We are proud to play our part in controlling the COVID-19 pandemic and look forward to bringing to bear our experience from Portsmouth, [NH] and Visp, [Switzerland] at our Geleen site in the Netherlands.”

The companies are expanding their collaboration to extend the drug substance manufacturing of Moderna’s COVID-19 vaccine with the addition of a new manufacturing line at Lonza’s Geleen, Netherlands, site. 

Lonza and Moderna to Expand Their COVID-19 Vaccine Drug Substance Manufacturing Collaboration

Moderna announced on June 1, 2021 that it has initiated a rolling submission process with FDA for a biologics license application (BLA) for its messenger RNA (mRNA) COVID-19 vaccine for individuals 18 years of age and older.

The company will continue to submit data to FDA on a rolling basis to support the BLA over the next few weeks with a request for priority review, Moderna said in a company press release. When the submission is completed, FDA will notify the company when the vaccine is formally accepted for review.

Currently, the vaccine is available in the United States under an emergency use authorization granted by FDA on December 18, 2020.

“We are pleased to announce this important step in the US regulatory process for a BLA of our COVID-19 vaccine,” said Stéphane Bancel, CEO of Moderna, in the press release. “We look forward to working with [FDA] and will continue to submit data from our Phase III study and complete the rolling submission.”

Moderna has initiated a rolling submission process with FDA for a biologics license application for its mRNA COVID-19 vaccine for individuals 18 years of age and older.

Moderna Initiates Rolling Submission of Biologics License Application for its COVID-19 Vaccine

PerkinElmer has entered into an agreement to acquire Nexcelom Bioscience, a US-based provider of image cytometry products for cell analysis, for $260 Million in cash. The transaction is expected to close in the second quarter of 2021, PerkinElmer announced in a May 12, 2021 press release.

Nexcelom provides automated cell counting instruments, image cytometry workstations, assays, and a variety of cell reagents. It also provides consumables and fit-for-purpose cell-counting method selection and development instructions that are compliant with ISO Cell Counting Standards and that aid in the development of cell and gene and immuno-oncology therapies, virology drugs, and vaccines.

The agreement follows PerkinElmer’s recent $383 million acquisition of UK-based Horizon Discovery Group, a cell engineering company specializing in gene editing and gene modulation (1).

“We are looking forward to bringing Nexcelom’s expertise and technologies in drug development together with our passion and solutions for drug discovery. This combination will expand our efforts to help academic, government, and biopharmaceutical organizations streamline their complete workflows and support efforts to accelerate time to target and time to market for novel therapies,” said Prahlad Singh, president and CEO of PerkinElmer, in the company press release.

“Our team is very excited to be joining forces with PerkinElmer to help scientists resolve some of today’s most pressing health challenges through modernizing cell-based assays using the most advanced cell models. Our organization has a deep commitment to innovation, and we are looking forward to continuing to grow our technology and customer footprint in combination with PerkinElmer’s strong global presence and infrastructure,” added Peter Li, president and CEO of Nexcelom, in the press release.

1. PerkinElmer, “PerkinElmer to Acquire Cell Engineering Company Horizon Discovery for $383 Million (£296 Million),” Press Release, Nov. 2, 2020.

The acquisition gives PerkinElmer access to Nexcelom Bioscience’s complementary cell counting and analysis capabilities and enhances its QA/QC capabilities.

PerkinElmer Expands Cell Biology Capabilities with Nexcelom Bioscience Acquisition

Colorcon announced on May 18, 2021 that it has added a new containment suite to its global headquarters in Harleysville, Pa. to further expand its technical capabilities.

According to a company press release, the new suite will provide clients with capabilities to develop prototype tablets or capsule dosage forms when API quantity is limited or the API potency requires a higher level of protection.

“Investing in this facility demonstrates Colorcon’s continued commitment to supporting pharmaceutical development in North America, reducing our customer’s time to market, and reflects our dedication to providing unparalleled products and services,” said Kurt Fegely, managing director, Colorcon Americas, in the press release. “We can now offer a complete cycle starting from the customer’s API, all the way to a finished coated dosage form within our facilities and provide prototypes ready for customer evaluation.”

“Many of our customers, especially in early development phase, work with very small quantities of active ingredients, which can have unknown safety profiles and can also be extremely costly and limited in availability,” added Charlie Cunningham, technical director, Colorcon, in the press release. “Our investment in the best equipment enables us to produce tablets and capsules with milligrams of active product in the safest of conditions.”

Colorcon’s new suite will provide clients with capabilities to develop prototype tablets or capsule dosage forms when API quantity is limited or the API potency requires a higher level of protection.