Author Archives: Gareth Macdonald

Cell and gene sector needs regulatory clarity says Andelyn

Cell and gene therapy developers are still uncertain of regulator expectations according to Andelyn Biosciences, which says industry would benefit from more balanced oversight. Various agencies have invested a lot of effort in the development of regulatory frameworks for cell and gene therapy development and manufacture. Recent examples include the US FDA‚Äôs draft guidance on trialing multiple versions of a cell therapy and the EMA‚Äôs document on quality expectations for products containing genetically modified cells. While these efforts are a…

Thermo’s $39bn+ sales driven by 25% y-o-y biopharma growth

Thermo Fisher has increased its guidance for 2022 predicting that COVID-19 related work and the contribution from PPD would drive growth. The technology and services firm announced the revision last week during a full year earnings call when it revealed that full year revenue grew 22% to¬†$39.21 billion. It went on to explain that organic revenue ‚Äď sales generated by Thermo‚Äôs core businesses ‚Äď increased 17%. It also said the contribution from acquisitions ‚Äď including contract research organization PPD which…

Catalent will increase CapEx to boost biologics business

Catalent will spend more than $700m to expand development and production capacity for biopharmaceutical products. The CDMO outlined the plan during its Q2 earning call this week, explaining it will spend 15 to 16% of its net revenue in fiscal 2022 ‚Äď which it expects to be in the $4.74 billion to $4.86 billion range ‚Äď to expand its biologics business. CFO Thomas Castellano told analysts ‚ÄúWe expect CapEx to be approximately 15% to 16% of our fiscal 2022 net…

CDMO Arranta buys Cytiva single-use tech for mRNA production

Live biologics CDMO¬†Arranta¬†Bio has bought a single-use manufacturing platform from¬†Cytiva¬†for the production of¬†mRNA vaccines.¬† The purchase is part of a $110 million investment by¬†Arranta¬†at its manufacturing and development facility in Watertown, Massachusetts. The CDMO also plans to open a¬†dedicate¬†space for lipid nanoparticle formulation¬† Joe Makowiecki from¬†Cytiva, told us ‚ÄúThis is the first¬†FlexFactory¬†for an mRNA product,‚ÄĚ adding that it will¬†‚Äúprovide¬†Arranta¬†the flexibility to manufacture mRNA vaccines and therapies from in vitro transcription (IVT) to drug product aseptic fill. ‚ÄĮ¬† He predicted that…

Fujifilm Dio signs long term supply deal and buys plant from Atara

Fujifilm Diosynth Biotechnologies will¬†buy¬†Atara Biotherapeutics‚Äô¬†T-Cell operations and facility in¬†Thousand Oaks, California for $100 million.¬† The deal will also see the¬†contract development and manufacturing organization (CDMO)¬†sign a long-term supply agreement covering both clinical and commercial production of Atara‚Äôs range allogeneic cell therapies.¬†¬† Specific candidates will include¬†tabelecleucel, ATA188 for multiple sclerosis and the allogeneic CAR T therapies, ATA3271 and ATA3219. Fujifilm Diosynth Biotechnologies also said it will expand use of the Thousand Oaks facility ‚Äď which is known as ATOM¬†‚Ästto manufacture a…

eBook: Antibody‚ÄďDrug Conjugates ‚ÄĒ
A New Generation of Approaches Is Changing the Game

Combining large proteins with linkers and cytotoxins, antibody‚Äďdrug conjugates (ADCs) may be the most complex drug molecules in development today. Despite early promise and product approvals, a number of technical concerns arose during product and process development. Characterizing and ensuring consistency in the number of small molecules that attach to the antibody ‚ÄĒ as well as ensuring their proper attachment and biophysics ‚ÄĒ all present significant challenges to ADC developers. Solving early problems associated with product quality has introduced a…

Samsung Bio buoyed by COVID, citing mRNA and mAbs as drivers

Samsung Biologics¬†says COVID-19 related demand drove growth in 2021 and predicts mRNA business will be key this year.¬† The¬†Korean contract development and manufacturing organization (CDMO)¬†saw revenue of KRW444.3 billion ($328 million) in the fourth quarter of 2021, up 18% on the comparable period in 2020.¬†¬† Profits increase 39% to KRW128.8 billion. For the full year revenue and operating profit grew 35% and 84%, respectively.¬† Samsung also said its fourth quarter operating margin jumped 29% due to increased utilization across all…

COVID driving revs but patent loss and markets continue to shape pharma

COVID-19 will be a revenue driver and R&D focus for biopharma, but pre-pandemic factors like patent expiry and emerging markets continue to shape the sector says IQVIA. The research services and analytics firm made the comments in a report, predicting spending on meds will reach $1.8 trillion by 2026 with a significant contribution coming from COVID-19 vaccine and booster shot sales. According to the authors, ‚ÄúThe total cumulative spending on COVID-19 vaccines since their introduction through 2026 is projected to…

RNA sector set for progress thanks to decades long research drive

The RNA drug sector has overcome some significant hurdles according to Alynlam Therapeutics CEO John Maraganore, who says industry efforts to work with these challenging molecules have laid the foundations for growth. ‚ÄúThe scientific obstacles are best defined here, small interfering RNA molecules are large. They’re charged. They’re susceptible to biological degradation. They’re also prone to activated immune sensor systems. And so the challenge of making drugs out of small interfering RNAs was really a formidable scientific challenge that needed…

Digital transformation must be driven by technology and savvy staff

Staff who understand the benefits of digital manufacturing are as important as the technology itself, according to a Novartis expert Digitization is a hot topic for biopharma. Advocates say the ability to monitor and model manufacturing data in real-time as a major advantage in terms of product quality and consistency. Technology is driving the shift from analog. But having staff who understand the benefits is as important according to Francisca Gouveia, a Senior Process Expert, MS&T at Novartis, who says…