Manufacturing

No timetable was given for the length of the planned evaluation or when data would be available, but Kite intends to use the information to expand its manufacturing options.

This $4.1 billion investment to build a second fill/finish manufacturing facility in Clayton, N.C., boosts Novo Nordisk's current 2024 investments in production to $6.8 billion.

Sarepta Therapeutics received expanded approval from FDA for Elevidys in the treatment of DMD in non-ambulatory patients as ell as ambulatory patients.

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

A new initiative will advance access to quality medicines and vaccines in Africa.

The companies have completed the expansion and qualification phase and now enter a stand-by phase for five years.

The $58 million investment has resulted in a 72,000-square-foot facility with a dedicated LC–MS space and molecular suites and will bring as many as 350 new jobs onto the campus.

Yimmugo, which was introduced in Europe at the end of 2022, could be on the market in the US within months.

Nadia Sellami, PhD, global segment lead for gene and cell therapy at PacBio, talks about long-read sequencing for cell and gene editing in a video interview.

John Bertagnolli, vice-president of Commercial Operations at Selkirk Pharma, discusses considerations when building and scaling up pharmaceutical facilities, including contamination control and aseptic processing challenges.

Ecolab Life Sciences and Repligen have launched a new affinity resin, DurA Cycle, for large-scale biologics manufacturing.

Key information is needed for excipients and their potential impact on continuous manufacturing processes.

Leveraging automation advancements can help improve efficiency in aseptic processing and speed up commercialization of critical drug products.

Syngene's new production platform offers rapid protein synthesis with lower risk.

The completed expansion at AGC Biologics'Copenhagen, Denmark, site, doubles the company's single-use bioreactor capacity for mammalian-based services.

Syntegon will expand its processing and packaging by acquiring the Spanish equipment supplier.

USP and FDA publish reports detailing drug shortage numbers and challenges through 2023.

The biopharma industry is looking at continuous chromatography for sensitive molecules.

The final drug product relies on the quality and reliability of the raw materials used in its production.

Lonza’s Joe Garrity and Jerry Jiang discuss the importance of not only automating CGT manufacturing, but also standardizing across processes.

Lonza’s Joe Garrity and Jerry Jiang discuss the latest trends and challenges in commercializing new CGTs.

In this episode of Drug Digest, industry experts discuss the current outsourcing landscape in the post-COVID world and the changes the pandemic has enforced in the demand for outsourced bioprocessing services.

Lars Petersen, CEO, FUJIFILM Diosynth Biotechnologies discusses the company’s strategic goals and meeting market demand for mammalian cell culture capacity.

Biosimilar analytical assessments focus on demonstrating biosimilarity and interchangeability with the reference biologic.

Founder and CEO of Atomic AI, Raphael Townshend, explores AI’s usefulness as a tool to characterize molecular structure and advance molecule engineering.