Jill Murphy

In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Tom Fletcher, director of Research and Development at FUJIFILM Irvine Scientific; and Bob Newman, PhD, chief scientific director at FUJIFILM Irvine Scientific, about formulation, specifically with how to prepare culture media for use, single use technologies, and automations to create closed systems in cell/gene therapies.

 is Director of Research and Development at FUJIFILM Irvine Scientific, a company that specializes in the development, manufacture and supply of cell culture media for Bioprocessing and Cell and Gene Therapy applications. As a part of the Bioproduction division, Tom leads the company’s efforts to provide relevant solutions for the various and frequent challenges presented by upstream process development. He has over 30 years of experience serving the biopharmaceutical industry, mostly by developing cell culture media solutions for large-scale production processes. Tom has previous experience in protein chemistry research at the University of California, Irvine School of Medicine and working at Becton Dickinson & Co.

 is Chief Scientific Officer at FUJIFILM Irvine Scientific. In this role, Robert leads scientific strategy, drives global product development, and expands R&D capability for the company. He was previously Senior Director for R&D at ATCC and R&D Manager Stem Cells at BD, and holds a PhD in Biochemistry and Molecular Biology from Georgetown University.

 presents the Drug Solutions podcast, where the editors will chat with industry experts from across the pharmaceutical and biopharmaceutical supply chain. Join us as experts share insights into your biggest questions—from the technologies, to strategies, to regulations related to the development and manufacture of drug products.

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Tom Fletcher, director of Research and Development at FUJIFILM Irvine Scientific; and Bob Newman, PhD, chief scientific director at FUJIFILM Irvine Scientific, discuss formulation, specifically with how to prepare culture media for use, single use technologies, and automations to create closed systems in cell/gene therapies with former Pharmaceutical Technology editor Jill Murphy. 

Drug Solutions Podcast: Staying on Track with Formulation of Cell Culture Media

Bourji Mourad, Director of Global Logistics & Partner Management at Sonoco ThermoSafe

 has spent the last 22+ years in the air cargo temperature management and cold chain logistics sector for safer transportation of time and temperature sensitive pharmaceutical products. Bourji is building a global network of stations for handling and repair of Pegasus ULD the first in market with aircraft certified temperature-controlled container as a Unit Load Device launched during 2022.

Bourji is also creating partnerships with selective Airlines and Freight Forwarders at corporate level making it possible for customers gain access to the Pegasus ULD fleet available around the world and offered by Sonoco under a rental program for shipping Pharmaceutical & Life Sciences products. Prior to joining Sonoco in late 2019, Bourji was with Envirotainer for 18 years as their Global Head of Partner Management & Compliance; also has 20 years-experience in the Shipping & Freight Forwarding industry prior to joining Envirotainer.

In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.

Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain

Key highlights from the CPHI Pharma Survey were announced as of Oct. 13, 2023, and the full findings will be published at CPHI Barcelona as part of the CPHI Annual Report. These results will provide insights from more than 250 global pharma executives, including discoveries such as pharma confidence dipping below the record scores of 2022, although it has remained extremely resilient despite wider macro uncertainly, according to the press release.

Further, the CPHI Pharma Index reported its second highest ever total, which was 2.5% down on the 2022 all-time high. These results highlight the medium-term trajectory of the industry and the strength of market fundamentals. The United States remained the top overall ranked nation, with India also continuing to make year-on-year inroads for significant growth in 2024. India did, however, remain at the top of the “growth” category for the second year in a row, scoring 7.8 out of 10. It also saw improvements in the score for “biologics quality” and finished behind the United States for “overall competitiveness”. According to the report, India is predicted to undergo a fast transformation from a generics hub to an innovation-focused pharma economy, driven by the incremental steps of large contract development and manufacturing organizations.

One of the more startling discoveries, according to the press release, is that the report predicts that an “India plus one” strategy will be adopted in the next five years. “When you look collectively at the data points in the Annual Survey, you see that after a reset from record scores in 2022—when many reported record profits—the industry is now well positioned for growth in 2024,” said Tara Dougal, Content Director–Pharma, in a press release.

The report also identified that many of the industry’s growth drivers that were seen in 2019 are still present but are now supplemented by the breakthroughs in microbiome therapeutics, while artificial intelligence now looks like the next efficiency used in the industry over the next five years.

“Our analysts predict outsourcing will continue its growth trajectory in 2024 and beyond—which is obviously a tremendously positive message for the industry as we approach CPHI Barcelona,” Dougal said in the press release. “It is also why we have ensured that ‘outsourcing strategies’ are a central theme of this year’s content, and the overall takeaway is of quiet and confident optimism. In fact, this will remain an ongoing theme for CPHI content, helping our audience to meet their objectives around partnering and supplier selection year-round.”

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These results will provide insights from more than 250 global pharma executives, including discoveries such as pharma confidence dipping below the record scores of 2022, although it has remained extremely resilient despite wider macro uncertainly, according to the press release.

CPHI Annual Survey Finds Global Pharma Resilient with India the Chief Beneficiary of Macro Changes

When considering manufacturing and the growth of drug formulation, it is evident that there has been change and many new advancements introduced to make processes more efficient. However, in terms of formulating highly potent drugs, their specific release requirements and poor aqueous bioavailability make them challenging to produce and analyze (1).

Although there may be difficulties seen with analytical challenges, the strength of oral solid dosage (OSD) forms and the manufacture of all pharmaceutical finished dosage forms continues to be prominent. According to research, the OSD market outlook is expected to continue growing and have low production costs, even with the knowledge of how unpredictable formulation may become (2).

Trends in Formulation for Highly Potent Drugs

 discussed new formulation trends with Shailesh Vengurlekar, senior VP of Quailty and Regulatory Affairs at LGM Pharma, and how the industry can go forward with these advancements, despite any challenges that may arise.

Read this article in the Trends in Formulation 2023 eBook

When referring to this article, please cite it as J. Murphy, "Trends in Formulation for Highly Potent Drugs," 

's Trends in Formulation eBook (October 2023).

When considering manufacturing and the growth of drug formulation, it is evident that there has been change and many new advancements introduced to make processes more efficient. 

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.”

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. 