Pharmaceutical Technology Editors

GSK and Tempus, a US-based precision medicine company, announced on Oct. 18, 2022 that they have entered into a new three-year collaboration agreement under which GSK will have access to Tempus’ artificial intelligence (AI)-enabled platform. GSK’s access will include Tempus’ library of de-identified patient data, which is drawn from Tempus’ work with over 40% of oncologists in US-based academic medical centers and community hospitals.

Under the new collaboration, which will utilize AI and machine learning capability, GSK and Tempus will work together to improve clinical trial design, speed up patient enrollment, and identify drug targets. These advantages are expected to contribute to GSK’s R&D success rate and provide patients with more personalized treatment faster. The agreement has a minimum financial commitment over the span of three years. GSK has made a $70 million initial payment toward that goal and has an option to extend the agreement for an additional two years.

The new agreement builds on the existing relationship between the companies, which began in 2020 and was based on the clinical-trial enrollment of patients with certain types of cancer. GSK and Tempus are currently collaborating on an open label Phase II study, under which the companies are applying an innovative, data-driven approach that is designed to accelerate and streamline study timelines. Their approach includes expediting the protocol development and intelligent site selection in under 60 days and enrolling the study’s initial patients within three months of the study launch.

“Th[e] [new] collaboration will provide GSK with unique insights to discover better medicines and transform drug discovery. Tempus complements the work our team is already doing at the intersection of genomics and machine learning across both early discovery and clinical trials,” said Tony Wood, chief scientific officer, GSK, in a company press release.

“GSK’s data-first approach to therapeutic research aligns with our own, and we believe that Tempus has the resources and capabilities to complement GSK’s dedication to data science in a way others can’t, given the breadth and depth of our platform. We both share a commitment to providing patients with more personalized therapeutic options to help them live longer and healthier lives,” said Eric Lefkofsky, founder and CEO, Tempus, in the release.

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Under the new collaboration with Tempus, GSK will have access to de-identified patient data to accelerate drug discovery, improve clinical trial design, and speed up enrollment.

GSK Expands Precision Medicine Collaboration with Tempus to Accelerate R&D

Aragen Life Sciences, an Indian contract research development and manufacturing organization, announced on Oct. 20, 2022 that it would operationalize its formulation manufacturing facility in Hyderabad, India by 2023. The new 12,000 ft² facility will include various dosage form capabilities for oral solids, liquids, topicals, films, as well as manufacturing technologies for granulation, film coating, spray drying, and tableting, and expansion plans are in place to add nano milling and hot melt extrusion capabilities.

According to a company press release, these new capabilities are designed to enhance the company’s early-stage development offerings by adding additional flexibility in terms of multiple dosage forms. The facility will also feature process technologies and flexible batch sizes from 1000 to 100,000 units.

“Aragen is investing in expanding capacities, extending capabilities and widening its geographic footprint to meet the needs of the global biopharma industry,” said Manni Kantipudi, CEO, Aragen Life Sciences, in the release. “We understand that our customers rely on our expertise, track record, and solution offerings. With this facility, we will consolidate our drug product development solution offerings and strengthen our position as a one-stop shop for all their needs – transforming ideas into solutions for better health.”

“The formulation manufacturing facility in Hyderabad is a significant development for us,” said Ramesh Subramanian, chief commercial officer, Aragen Life Sciences, in the release. “The new capacity will allow us to address the increasing interest from our customers for integrated development solutions. It also fits in well with our stated vision of becoming the ‘R&D partner of choice’ for our customers.”

Aragen’s new 12,000 ft² facility will include various dosage form capabilities, including oral solids, liquids, topicals, and films.

Aragen to Invest in New Formulation Manufacturing Facility in Hyderabad, India

Recipharm, a global contract development and manufacturing organization, announced on Oct. 19, 2022 that it would be investing in a new high speed filling line for pre-filled syringes and cartridges at its sterile manufacturing facility in Wasserburg, Germany. The line, which is expected to be ready for its first good manufacturing practice batch run in May 2023, will be fully Annex 1 compliant and is designed to support both small and large volume projects.

According to a company press release, this decision was made as a result of increased customer demand in high growth fill formats. The Wasserburg facility specializes in producing more complex formats, ranging from lyophilization technology to aseptic filling into vials, syringes, and cartridges.

“The demand for pre-filled syringes is rapidly growing, with the projected market value by 2030 expecting to reach $6.5 billion,” said Marc Funk, CEO, Recipharm, in the release. “We are proud to be able to offer such a comprehensive service to our customers spanning device design, development and manufacturing to drug product fill & finish, and look forward to continuing to simplify the journey to market for our customers and of course helping patients access vital medicines.”

Recipharm’s new high speed filling line, designed for pre-filled syringes and cartridges, is expected to be operational by May 2023.

Recipharm to Add High-Speed Filling Line to Wasserburg Facility

The American Association of Pharmaceutical Scientists (AAPS), a non-profit, professional society of 7,000 pharmaceutical scientists, announced on Oct. 19, 2022 that it would be the exclusive authority advising RX Global on scientific focus areas for Interphex, an 8,000 person event focusing on the commercial contracting space. AAPS and RX are now developing plans for the 2023 Interphex meeting, which is set to take place April 25-27, 2023, at the Javits Center in New York City.

“This is an important step for us in pursuing our mission of bringing scientists together to advance cures and therapies that will help patients around the world,” said Patrick Sinko, president, AAPS, in an agency press release. “We are going to support RX in creating a scientific experience at Interphex that helps industry professionals look into the future while solving today’s problems.”

“The collaboration with AAPS is an important next chapter for Interphex,” said Marie Brown, group vice-president, RX, in the release. “Interphex has traditionally been an event primarily focused on product discovery and finding solutions to effectively develop and manufacture quality products. We are excited that AAPS will elevate and expand the content to attract and satisfy the educational needs of research scientists and provide that important link between science and commercialization.”

AAPS will exclusively advise RX Global on scientific focus areas for Interphex 2023, which is set to take place at the Javits Center in New York City next spring.

AAPS to Provide Scientific Programming Oversight for Interphex

The Aenova Group, a global contract manufacturing and development organization, and Microcaps, a Swiss biotechnology start-up specializing in microencapsulation technology, announced a strategic partnership on Oct. 21, 2022. The aim of the partnership is to accelerate and improve the development and production of pharmaceuticals, food supplements, and other products.

According to a company press release, Microcaps will use its patented microencapsulation technology platform to enable customized formulations such as release, protective coating and texture, etc. This is intended to allow Aenova to offer a broader range of new product development and life cycle management solutions for micro and convention capsule formulations, such as enhanced taste masking, controlled release, targeted release, increased bioavailability, and improved active pharmaceutical ingredient stability.

"In our now launched partnership, the whole is clearly more than the sum of its parts, because the portfolio and the experience and knowledge of the individual companies complement each other perfectly in order to be able to offer even better added value for our customers in the pharmaceutical as well as the food industry even faster,” said Jan Kengelbach, CEO, Aenova Group, and Michael Hagander, co-founder and co-CEO, Microcaps, in a joint statement in the release.

More details about the partnership will be discussed at this year’s CPHI conference November 1 to 3, 2022 in Frankfurt/Main at the Aenova in Hall 9, booth 90J60.

Aenova Group and Microcaps are partnering to enable new customized formulations for product development and life cycle management solutions.

Aenova and Microcaps Enter Strategic Collaboration

The European Medicines Agency announced on Oct. 19, 2022 that its Committee for Medicinal Products for Human Use (CHMP) has recommended approval of COVID-19 vaccines that target the original strain of SARS-CoV-2 for children aged six months to four years old for Comirnaty and six months to five years for Spikevax. Both vaccines are approved for adults and children ages five and up for Comirnaty and six and up for Spikevax.

According to EMA, the dosage of these vaccines will be lower in the younger age groups. Comirnaty will be given in three doses (of 3 micrograms each) with the first two doses given three weeks apart and the third dose given at least eight weeks after the second dose. Spikevax’s dosage for the younger age group will be two doses (of 25 micrograms each), given four weeks apart.

A study showed that Comirnaty had a comparable immune response at the lower dose in young children compared with the higher dose of 30 micrograms in people ages 16–25. Another study showed that Spikevax’s lower dose for young children was comparable to the higher dose of 100 micrograms in 18–25-year-olds. Side effects were also comparable to the older age groups.

“The CHMP therefore concluded that the benefits of Comirnaty and Spikevax in children aged from 6 months to 4 and 5 years, respectively, outweigh the risks. The safety and efficacy of both vaccines, in children and adults, will continue to be monitored closely as they are used in vaccination campaigns in EU [European Union] Member States through the EU pharmacovigilance system and ongoing and additional studies conducted by the company and coordinated by European authorities,” the agency stated in a press release.

CHMP’s recommendation will be sent to the European Commission for final decision applicable to EU Member States.

The agency has recommended approval of Comirnaty and Spikevax for children from six months of age.