Pharmaceutical Technology Editors

Univercells Technologies and the National Institute of Bioprocessing Research and Training (NIBRT) in Dublin, Ireland, announced on May 18, 2021 that they have entered into a collaboration to address the need for training in cell and gene therapies (CGTs) using next-generation technologies for viral products manufacture.

Through the partnership, Univercells will introduce the intermediate capacity scale-X carbo system, which includes a fixed-bed bioreactor and in-line concentration, to NIBRT’s facility for hands-on demonstration and training to enforce continued education and bridge the clinical gap between new CGT manufacturing staff and expert level biopharmaceutical professionals, Univercells said in a company press release.

“Across the industry, developers and manufacturers are looking for next generation technologies. They require purposefully designed tools that apply the principles of intensification, integration, and semi- or fully continuous processing to overcome the existing barriers to discovery and commercialization in viral manufacturing,” said CEO of Univercells Technologies, Mathias Garny, in the press release. “Our scale-X product series is a uniquely intensified and automated solution that can help to bring advanced therapies to the market using reliable, reproducible processes with increased capacity in a decreased footprint. We are honored to have it featured at a respected institute like NIBRT and contribute to training the workforce that will drive manufacture of the advance therapies of tomorrow.”

“We are always looking out for the latest bioprocessing innovations to accomplish our mission of supporting the biopharmaceutical industry with access to the most advanced technologies for research and training,” added John Milne, NIBRT training director, in the press release. “The scale-X carbo system is the ideal intermediate-scale system to train on process development, optimization, and scale-up principles through R&D to commercial capacity. The scale-X carbo system will help our team to deliver cutting edge training and research collaborations in viral vector development.”

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Univercells will introduce the intermediate capacity scale-X carbo system to NIBRT’s facility for hands-on demonstration and training in CGT.

Univercells and NIBRT Team Up to Address Needs for Cell and Gene Therapy Training 

Sandoz, a Novartis division, announced on May 18, 2021 that it plans to strengthen its European antibiotics manufacturing network by expanding its production capabilities in Kundl, Austria, and Palafolls, Spain.

In Kundl, the company plans to invest more than €100 million (US$123 million) into new manufacturing technology for the production of oral amoxicillin, an API for its leading penicillin product, Sandoz said in a company press release. The Palfolls expansion will include a facility expansion and an investment of €50 million (US$61 million) in new production technology and increased capacity for the production of sterile penicillin APIs and sterile API mixtures.

Additionally, the company plans to phase out production of APIs at its Les Franqueses, Spain, site and transfer it to its Palafolls site in 2025.

“Antibiotics are the backbone of modern healthcare and a key strategic pillar of our business,” said Richard Saynor, CEO, Sandoz, in the press release. “Despite a temporary drop in demand due to the pandemic, we remain as confident as ever in the mid- to long-term prospects for this segment, which meets a significant quantity of the global disease burden. This investment, which comes shortly after we announced plans to acquire GSK’s global cephalosporin antibiotics, confirms our commitment to securing the future of our leading global business.”

“Our goal is to produce and supply high-quality antibiotics at a cost-competitive price to patients around the world,” added Giovanni Barbella, head of Sandoz Technical Operations, in the press release. “The important investments announced today will enable our world-class manufacturing network in Europe to meet future requirements.”

Sandoz plans to strengthen its European antibiotics manufacturing network by expanding its production capabilities in Kundl, Austria, and Palafolls, Spain.

Sandoz to Expand Production Capabilities to Strengthen its European Antibiotics Manufacturing Network

MilliporeSigma announced on May 18, 2021 that VectorY, a Netherlands-based biotechnology company, has been selected as the European winner of its 2021 Advance Biotech Grant Program.

The company was selected for its development of proprietary and partnered programs based on a novel adeno-associated viruses (AAV) platform for the treatment of muscular and neurodegenerative disorders, MilliporeSigma said in a company press release. The grant award will provide VectorY with MilliporeSigma products and consultation in upstream processing, sterile and virus filtration, and process development support for gene therapy manufacturing. The award will also accelerate their candidate development and further expand the upstream activities already initiated with the Emerging Biotech team at MilliporeSigma.

VectorY’s offerings include a pipeline of vectorized antibodies for the treatment of muscular and central nervous system diseases with unmet needs, and next-generation vectors and advanced bioprocess technologies aimed at flexible production and overcoming challenges in delivery and manufacturing for advanced gene therapies.

“Our goal is to support the biotech community in bringing the next generation of therapies to the clinic, faster and more efficiently,” said Andrew Bulpin, head of Process Solutions at MilliporeSigma, in the press release. “VectorY’s work could be instrumental in developing potential new treatments for muscular and neurodegenerative diseases.”

“Winning MilliporeSigma’s Advance Biotech Grant is an incredible honor,” added Anthony Newcombe, chief operating officer of VectorY, in the press release. “The support from MilliporeSigma will help us expedite our technology programs and further production scale solutions for next-generation gene therapy manufacturing.”

VectorY, a Netherlands-based biotechnology company, has been selected as the European winner of MilliporeSigma’s 2021 Advance Biotech Grant Program. 

MilliporeSigma Announces European Winner of its 2021 Advance Biotech Grant Program

on May 17, 2021 that its human medicines committee (CHMP) has recommended changing the approved storage conditions for Pfizer/BioNTech’s COVID-19 vaccine, Comirnaty. The recommendation extends the approved storage period of the unopened thawed vial at 2–8 

The change follows EMA’s assessment of additional stability data, and the agency expects it to have an impact on planning and logistics for the rollout of the vaccine to member states in the European Union. The change will be implemented in updated product labeling.

The agency’s human medicines committee has recommended extending the approved storage period of unopened thawed vials at 2–8 0C from five days to 31 days.

EMA Recommends Change in Storage Conditions for Pfizer/BioNTech Vaccine

BD (Becton, Dickinson and Company), a US-based medical technology company, announced on May 18, 2021 that it plans to build a €165 million (USD$200 million) high-tech manufacturing facility in Zaragoza, Spain, that will create up to 600 jobs by 2030.

The new site will initially house a workforce of 150 people in an area of 8000 m2 (86,000 ft2), with the numbers eventually rising to 600 people in an area of 30,000 m2 (323,000 ft2) by 2030, BD said in a company press release. Construction of the fully-digital, eco-efficient site will begin in late 2021, making it the fourth BD manufacturing site in Spain.

"BD's new plant in Zaragoza will produce drug delivery devices, primarily for pharmaceutical companies that supply the European market with drugs in prefillable syringes, such as vaccines and other biologic drugs," said Eric Borin, worldwide president of BD Pharmaceutical Systems, in the press release. "This new plant will also add needed capacity to support major vaccination campaigns, such as the one currently taking place in response to the COVID-19 pandemic."

BD’s new high-tech manufacturing facility in Zaragoza, Spain, will create up to 600 jobs by 2030.

BD to Build $200 Million Manufacturing Facility in Spain

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.