Alivia Leon

Catalent announced on April 6, 2023 that it has begun construction of a $20 million expansion project at its clinical supply facility in Schorndorf, Germany. The project will increase the site’s footprint by 32,000 ft2 and add capacity for the storage and handling of clinical trial supply materials at controlled room temperatures between 15 °C and 25 °C.

Furthermore, Catalent will create space in the original building to accommodate the installation of a new, fully automatic bottle-filling line. The company will also establish a dedicated area for its FastChain supply service. Work on the site is expected to be completed by June 2024.

Catalent’s Schorndorf clinical supply facility opened in 1996 and provides comprehensive clinical supply services, including multi-lingual project services, comparator sourcing, primary and secondary packaging, labeling, clinical storage and distribution, and returns and destruction. The company’s FastChain supply service is a continuous good manufacturing practice approach that decouples primary from secondary packaging to enable timely and cost-effective adaptation and regional supply of clinical materials.

“Our site in Schorndorf plays a key strategic role in our global clinical supply network, and this expansion will provide much needed capacity and capabilities to meet the growing needs of customers,” said Ricky Hopson, president, division head for clinical development & supply at Catalent, in a company press release. “Additional temperature-controlled handling, storage, and distribution means the facility is well-equipped to respond to the growing demand for clinical supply capacity and services in the region, including for products requiring cold chain support. Working closely with our adjacent oral dose manufacturing center of excellence, and our European development centers for oral, biologic, cell therapy and gene therapy products, customers have access to fully integrated development, clinical packaging, and distribution solutions.”

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The construction will expand Catalent’s clinical supply facility in Schorndorf, Germany. 

Catalent Begins Construction of New $20 Million Expansion to Germany Facility

Forecyte Bio held an opening ceremony on March 31, 2023, for its new cell and gene therapy good manufacturing practice (GMP) facility in Shanghai, China, following the successful opening of its United States facility in January 2023. The new Shanghai facility totals 140,000 ft2 with a total investment of nearly $40 million. It offers multiple GMP production lines for plasmids, viral vectors, and cell therapies.

The dual sites in the US and China offer advantages to cell and gene therapy (CGT) companies, as both facilities offer high-quality production capacities and an executive team experienced in CGT chemistry, manufacturing, and controls manufacturing. Forcyte Bio’s goal is to help its customers accelerate their product development process from R&D to clinic and to market. The company also enables CGT products to be manufactured and filed in multiple nations.

"The CGT industry has entered a stage of rapid development,” said Yingke He, founder and CEO of Forecyte Bio, during the opening ceremony. “With the opening of the Shanghai production and R&D center, the manufacturing capacity of Forecyte Bio in China and the United States are ready to serve its customers from US, China, and around the globe. Thanks to the trust and support from our landlord, our customers, and investors, and mostly our hardworking employees, we have been able to reach today's achievement in such a short time."
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Forecyte Bio has opened a new GMP facility in Shanghai just two months after its sister site in the United States. 

Forecyte Bio Opens New GMP Facility in Shanghai

Meissner, a company focused on advanced microfiltration and therapeutic manufacturing systems, announced on April 6, 2023 that it will invest nearly $250 million in a new manufacturing facility in Athens-Clarke County, Ga.

The new facility will be located at the Christian Industrial Tract in Winterville. When complete, the new campus will more than double the company’s manufacturing footprint in the United States as the company expands its current operations. The project is also expected to create more than 1700 new jobs over the next eight years, according to a company press release.

Operations are expected to begin in early 2026. The new site is expected to consist of multiple structures, which will include state-of-the-art cleanroom facilities, laboratories, R&D, and office spaces.

“We are thrilled to embark on this important expansion and are excited to build our second US manufacturing campus in Athens-Clarke County,” said Christopher Meissner, president of Meissner, in the press release. “The state of Georgia, and Athens-Clarke County in particular, is an ideal location with an incredible talent pool and strong geographic position that allows us to serve clients on the East Coast and throughout the world. We sincerely appreciate the partnership with state and county officials and are eager to break ground to join the community in Athens-Clarke County.”

The new site will include state-of-the-art cleanroom facilities, laboratories, R&D, and office spaces.

Meissner to Invest $250 Million in New Manufacturing Facility in US

Lonza announced on April 4, 2023 an agreement with ABL Bio, a Korean biologics company with a focus on bispecific antibodies for immune-oncology and neurodegenerative diseases. The collaboration agreement between the two companies supports the development and manufacturing of ABL Bio’s new bispecific antibody product.

Under the agreement, Lonza will provide ABL Bio with an end-to-end solution and an integrated offering to support the bispecific antibody candidate from DNA to potential investigational new drug (IND) application. ABL Bio will also gain access to Lonza’s DNA-to-IND program, which is designed to support biotech companies in realizing the full potential of bispecific drug candidates, accelerating their path to clinic and developing a robust and scalable manufacturing process.

“With the biologics pipeline evolving towards more complex protein formats, bi- and multi-specific molecules are a growing part of Lonza’s portfolio,” said Jean-Christophe Hyvert, president of biologics, Lonza, in a company press release. “For more than 35 years, our teams have built extensive experience and capabilities in this area, and we are committed to supporting our customers on their unique journey to IND. This collaboration will provide ABL Bio with greater flexibility and speed on the path to commercialization. We look forward to working together to bring this innovative therapeutic antibody candidate one step closer to patients.”

Lonza and ABL Bio are collaborating on the development and manufacture of bispecific antibody product. 

Lonza and ABL Bio Collaborate on Bispecific Antibody Product

NextPharma, a European contract development and manufacturing organization (CDMO), announced on April 1, 2023 that it has acquired a leading chewable tablets manufacturing site from Takeda located in Asker, Norway.

The site, which has approximately 170 employees, has operated for more than 50 years and produces a broad portfolio of strengths and flavors of calcium/vitamin D3 chewable tablets. The site will be NextPharma’s center of excellence for the development and manufacturing of chewable tablet forms, adding to the company’s existing site portfolio.

“With NextPharma, we are confident that Takeda has chosen a buyer who will help nurture and grow the Asker site,” said Bjørn Lie, head of the manufacturing site at Asker, in a company press release. “We are all excited about joining the NextPharma team and look forward to working together to drive the long-term development and growth of the business and our people.”

“We are excited by the addition of a world-class manufacturing site and a new center of excellence for chewable tablets to our operational network, allowing us to further broaden our technology offering for both existing and new customers,” added Peter Burema, CEO of NextPharma, in the release. “These technologies, combined with the know-how and expertise of the site’s employees, will continue to benefit patients across the world.”
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NextPharma has acquired a leading European chewable tablets manufacturing site from Takeda in Asker, Norway. 

NextPharma Acquires Chewable Tablets Manufacturing Site in Norway

Ahead of a CPHI North America panel discussion—

Redesigning the Supply Chain–The Road to Increased Resilience—

led by Bikash Chatterjee, CEO of Pharmatech Associates, a USP company, Chatterjee forewarns that suppliers’ supply chain and continuous manufacturing and resilience issues are risks for contract development and manufacturing organizations (CDMOs) in the United States. While CDMO supply chains are potentially the biggest single risk to product resilience, they remain an area often overlooked by drug sponsors in partnering criteria, according to a CPHI press release.

Ahead of the conference, Chatterjee suggests that both CDMOs and sponsors need to be looking at their supply chain today to avoid the risks of tomorrow, due to the demand for services increasing at the same rate as US regulatory burdens. With many of the largest CDMOs now running at capacity, drug sponsors will need to focus on mitigating risk and building resiliency when using smaller or mid-sized CDMOs.

Continuous manufacturing and multi-tenant architectures for cross-party data sharing are two technologies that bode well for increased supply chain resilience. Chatterjee suggests that equipment for continuous manufacturing has advanced considerably and is now cost-effective and easier to operate in a PAT environment. Chatterjee also stated that 2023 is potentially the year that the risks manifest in some real-world supply chain problem within the US.

CPHI North America 2023 will bring thousands of pharma professionals from more than 80 countries to the Pennsylvania Convention Centre on April 25–27 to meet, connect, and attend conference sessions where leading CDMOs will seek to address capacity challenges and supply chain contingencies. It will run as a hybrid event, with its digital platform opening ahead of the in-person event and continuing for two months post-show.

A CPHI North America panel discussion forewarns that CDMO supply chains are potentially the biggest single risk to product resilience. 