Jill Murphy

Sterling Pharma Solutions acquired UK-based NewChem Technologies, a contract services provider focused on organic chemistry and supplying customers across a range of industries such as pharmaceuticals, diagnostics, and biotechnology, according to the press release.

Sterling is known as a global contract development and manufacturing organization, and their network spreads to a manufacturing site in Cramlington, United Kingdom, a recently GMP-licensed dedicated bioconjugation facility in Deeside, and a 111-acre site in Ringaskiddy, Ireland.

The acquisition of NewChem adds further scientific resource and expertise to Sterling’s chemistry services while finding ways to synthesize customers’ molecules and establish a place in development and scale up. The financial details were not disclosed, but the deal includes all of NewChem’s assets and employees. Additionally, the founders of NewChem, Bob Tyson and Bernard Golding, will continue in their roles as site head and science director.

The site, located within Newcastle, will work hand-in-hand with the Sterling facility in Cary, NC, which operates as an early-phase development center, according to the press release.

“Over the last three years, Sterling has grown significantly, both organically and through a global strategy of acquisitions, and this latest deal marks the next step that will help us achieve our aim of becoming the preferred partner and provider of small molecule services to the pharmaceutical industry,” said Kevin Cook, CEO at Sterling, in a press release. “The expertise and experience within the well-respected and talented NewChem team will provide the business with additional capacity to solve complex chemistry challenges. NewChem’s connections with academia is closely aligned with Sterling’s Technology and Innovation Program, which sees us work with a number of leading global academic institutions to bring the latest technologies and innovations to our customers.”

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Sterling Pharma Acquires NewChem Technologies

eXmoor pharma, the full-service cell and gene therapy (CGT) manufacturing partner, launched its new Cell and Gene Therapy Centre good manufacturing practice (GMP) facility on Oct. 11, 2023 to support the production of multiple therapies for clinical trials. According to the press release, the 65,000-square-foot facility is designed with the capacity and capability to help scale the next generation of CGTs for human trials and beyond. It is also the final step in eXmoor’s expansion into a full-service CGT contract development and manufacturing organization (CDMO).

“The opening of this facility marks a landmark achievement for us, as we bring our 19 years of translation consulting and process development experience to directly enable the rapid development of life changing therapies in the UK [United Kingdom] and beyond,” said Angela Osborne, CEO of eXmoor, in a press release. “To date, we have completed more than 500 projects, including the design of 37 CGT manufacturing facilities. Our Cell and Gene Therapy Centre represents the culmination of all that experience.”

The new facility based in Bristol was constructed in 14 months to fully expedite more GMP manufacturing facilities in the CGT space, according to the release. The new Cell and Gene Therapy Center is specialized in labs for clients’ process and analytical development with the capability for technology transfer to GMP production on the same site.

Four large, Grade C processing modules with airlocks

Process-agnostic design for both cell and gene therapy manufacturing

Complete segregation between processing modules

Up to two-times 200L bioreactor scale for viral vector or allogeneic cell therapy manufacture or space for up to five autologous cell therapy stations

Fully serviced with all GMP gas supplies for any cell/gene therapy process

Uninterruptable power supply and emergency generator for electrical back up

Expansion space of 12,000 sq ft for another nine suites to grow with eXmoor’s clients into scaled-up and -out manufacturing for pivotal trials and in-market supply

6500 sq ft for process development, quality control, and analytical labs, with ‘same again’ expansion potential for additional manufacturing and commercialization partnerships.

The facility has also been designed with no fossil fuel usage on site, relying instead on solar technology and heat pumps, according to the press release.

The 65,000-square-foot facility is designed with the capacity and capability to help scale the next generation of CGTs for human trials and beyond. 

eXmoor pharma Expands into Full-Service Cell and Gene Therapy CDMO Partner with Opening of GMP Facilities 

Gritgen Therapeutics, a biotechnology company focused on gene therapy products, announced the successful validation and official launch of operations at its commercial good manufacturing practice (GMP) facility located in Suzhou Industrial Park. According to the press release, the milestone sets the stage for the development of Gritgen’s Phase III clinical and commercial product for hemophilia A (HA). Further, the construction of Gritgen’s GMP facility strictly adheres to the global current GMP (CGMP) standards and complies with the regulatory guidelines of authoritative agencies including the National Medical Products Administration (NMPA), FDA, and the European Medicines Agency (EMA).

The new facility is 8600 square meters and covers plasmid production and AAV production lines. In addition, the production lines are based on a mature and reliable upstream process with mammalian cell suspension, and a downstream process with chromatography platform technology, equipped with disposable bioreactors of different scales (the largest scale reaches 1000 liters).

According to the press release, the facility is equipped with pilot filling lines and commercial fill/finish lines to meet the need of drug product manufacture, and has a quality control laboratory covering biochemical, physicochemical, molecular biological, and microbiological tests. The production lines in the facility also are completely physically separated, which comprehensively controls the risk of cross-contamination and is a solid foundation for the global supply chain guarantee of innovative gene therapy products.

“The validation and operational launch of our GMP facility represents a pivotal juncture for Gritgen, which provides an important vector foundation for the company to realize commercialization,” said Dr. Wu Fenglan, co-founder and CEO of Gritgen, in a press release. “At the present, a bottleneck of gene therapy is the manufacturing process, a challenge resonating globally. The production capacity of large-scale, high-quality, cost controllable vectors is an important driving force for the development of gene therapy industry."

Further, the construction of Gritgen’s GMP facility strictly adheres to the global current GMP (CGMP) standards and complies with the regulatory guidelines of authoritative agencies including the National Medical Products Administration (NMPA), FDA, and the European Medicines Agency (EMA).

Gritgen Therapeutics Launches Commercial GMP Facility in China

ScaleReady and CTMC have announced a partnership as of Oct. 4, 2023 to help lessen the manufacturing barriers that are restricting life-saving cell and gene therapies from reaching more patients by integrating cutting-edge automation tools. According to the press release, the agreement will enable CTMC to strategically scale the recently completed good manufacturing practice facility to drive high-throughput manufacturing utilizing the automated, closed system capabilities of the Fresenius Kabi Lovo and Cue cell processing systems.

ScaleReady is defined as delivering rapid expansion of immune cells at any scale by reducing complexity and cost while providing superior repeatability and cell quality. Founded in 2020, ScaleReady is a joint venture of Bio-Techne, Fresenius Kabi, and Wilson Wolf, according to the press release.

“CTMC sees tremendous value in using products with a solid track record of clinical and commercially approved cell therapy successes. ScaleReady’s expertise and platform access will help us to leverage innovative technologies, like the Lovo, for our cell therapy process,” said Laine Linden, head of CTMC Technical Operations, in a press release. “With the addition of the Fresenius Kabi Cue to our manufacturing platform, we hope to drive down variability and increase the number of patients we can successfully treat by automating and closing the final fill and finish steps of our cell therapy products.”

“We are honored to partner with CTMC and support their work to commercialize therapies from some of the world's leading cancer experts. By providing this state-of-the-art facility and their technical experts with the Cue system, we can functionally close the critical final fill and finish steps, which have historically been manual and open processes,” said Josh Ludwig, global commercial director, ScaleReady, in a press release. “This leading-edge technology brings a new level of automation and scalability. Our expanded partnership with CTMC will significantly impact not only the research and the organization but also the patients in need of life-saving therapies.”

The agreement will enable CTMC to strategically scale the recently completed good manufacturing practice facility to drive high-throughput manufacturing utilizing the automated, closed system capabilities of the Fresenius Kabi Lovo and Cue cell processing systems.

CTMC Partners with ScaleReady for Combatting Manufacturing Barriers

*Editor's note: story has been updated to include financial terms.

Eli Lilly and Company (Lilly) and POINT Biopharma Global (POINT) announced on Oct. 3, 2023 a definitive agreement for Lilly to acquire POINT, a radiopharmaceutical company with a pipeline of clinical and preclinical-stage radioligand therapies in development for the treatment of cancer. According to a company press release, Lilly will acquire POINT for approximately $1.4 billion ($12.50 per share) in cash. 

Radioligand therapy can assist in the precise targeting of cancer by linking a radioisotope to a targeting molecule that delivers radiation directly to cancer cells, which enables significant anti-tumor efficacy while limiting the impact to healthy issue. Further, POINT is working on PNT20021, which is a prostate-specific membrane antigen (PSMA) targeted radioligand therapy in development for patients with metastatic castration-resistant prostate cancer (mCRPC) after progression on hormonal treatment. PNT20021 is known as a somatostatin receptor (SSTR) targeted radioligand therapy in development for the treatment of patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

Further, beyond the late-stage clinical pipeline, POINT has several additional programs in earlier stages of clinical and preclinical development. The company operates a 180,000-square-foot radiopharmaceutical manufacturing campus in Indianapolis, in addition to a radiopharmaceutical research and development center in Toronto. Both of the facilities will be used alongside POINT’s extensive network of supply chain partners for sourcing radioisotopes and their precursors.

"Over the past few years, we have seen how well-designed radiopharmaceuticals can demonstrate meaningful results for patients with cancer and rapidly integrate into standards of care, yet the field remains in the early days of the impact it may ultimately deliver," said Jacob Van Naarden, President of Loxo@Lilly, the oncology unit of Eli Lilly and Company, in a press release. "We are excited by the potential of this emerging modality and see the acquisition of POINT as the beginning of our investment in developing multiple meaningful radioligand medicines for hard-to-treat cancers, as we have done in small molecule and biologic oncology drug discovery and development. We look forward to welcoming POINT colleagues to Lilly and working together to build upon their achievements as we develop a pipeline of meaningful new radioligand treatments for patients."

Joe McCann, PhD, CEO of POINT, also said in the press release, "The combination of POINT's team, infrastructure and capabilities with Lilly's global resources and experience could significantly accelerate the discovery, development, and global access to radiopharmaceuticals. I look forward to a future where patients all over the world can benefit from the new cancer treatment options made possible by the joining of our two companies today."

POINT is a radiopharmaceutical company with a pipeline of clinical and preclinical-stage radioligand therapies in development for the treatment of cancer.

Lilly to Acquire POINT Biopharma 

Particle Measuring Systems Inc. announced the acquisition of Environmental Monitoring Services and EMS Particle Solutions and their parent company on Oct. 2, 2023. According to the press release, EMS is a leader in the cleanroom industry, delivering complete cleanroom monitoring and control solutions, services to customers, and ensuring quality by design from inception to process control.

Particle Measuring Systems has experience in contamination monitoring and control for cleanrooms and aseptic manufacturing environments. Additionally, the acquisition aligns with Particle Measuring Systems’ strategy to be direct in every major geographical market to best support and service customers with advanced contamination monitoring and control solutions. Their partnership with EMS will last approximately 30 years as an exclusive sales and service channel for customers in these strategic territories.

“It has been gratifying to grow EMS over the last 30 years,” said Dave Nolan, managing director at EMS, in a press release. “This is an exciting and natural next step for our organization and I’m looking forward to continuing as part of this great team.”

“We are always looking for ways to provide our customers with better solutions while maintaining our strong growth trajectory and being recognized as an employer of choice by our employees,” said interim Particle Measuring Systems, Inc. President, Mark Fleiner, in a press release. “Acquiring EMS helps us achieve these goals while also preparing for continuity of service and solutions in this strategic geography.”

Source: Particle Measuring Systems (PDF press release)

EMS is a leader in the cleanroom industry, delivering complete cleanroom monitoring and control solutions, services to customers, and ensuring quality by design from inception to process control.