Manufacturing

EU regulators clear Otsuka’s antisense injectable to prevent hereditary angioedema attacks, reinforcing momentum for RNA-based rare disease medicines.

Next-gen antibody R&D is shifting to multifunctional modalities driven by manufacturing scale and regulatory acceleration.

In 2026, AI and automation are anticipated to solve talent gaps and economic shifts to drive resilient drug discovery and manufacturing.

The partnership boosts BOT+BAL immunotherapy, securing US biologics manufacturing and accelerating Phase III mCRC development globally.

As the J.P. Morgan Healthcare Conference gets underway, Lonza’s Michael De Marco weighs in on regional manufacturing shifts as biotech pipelines mature, signaling new therapy launches within 12–18 months.

Johnson & Johnson reinforces its long-term domestic investment strategy with a new $2 billion biologics facility in Wilson, North Carolina, further elevating the state’s role as a global life sciences hub.

In part two of an interview, Daniel Delubac, iOrganBio CEO, explains how digitized, in-vitro human biology models aim to improve preclinical drug testing.

AI-driven human cell models aim to replace animal testing and deliver more accurate, data-driven insights, says iOrganBio CEO Daniel Delubac ahead of the J.P. Morgan Healthcare Conference.

Single-use technologies provide efficiency and flexibility while reducing risk in the manufacture of cell and gene therapies.

Digitalization is expected to reshape bioprocessing, supply chains, and quality systems for biopharma developers amid tariffs, geopolitics, and shifting capital flows, according to BioPlan Associates’ Eric Langer.

The CDC has narrowed pediatric vaccine guidance, resetting evidence expectations and signaling potential shifts in vaccine uptake and market demand.

Biomanufacturing is shifting toward more resilient and digitized networks for enhanced supply security amid global and supply-chain volatility.

Key 2025 FDA draft and final guidances emphasize the modernization of biotech regulations, acceleration of rare-disease therapies, and streamlining of biosimilar pathways.

Autolomous and Trenchant’s partnership, begun early in 2025, addresses unmet CGT manufacturing needs, including slashing costs and cutting timelines.

A look at interchangeable biosimilars gaining FDA approval, the growth in global partnerships, and the rising biologics patent cliff.

Samsung Biologics’ Maryland acquisition signals a major push into US biologics manufacturing, reshaping the company’s capacity strategy and supply chain resilience.

This past year in biologics was marked by clinical trends, manufacturing scalability, and regulatory acceleration for antibody therapeutics.

Norgine has gained regional rights to Vir Biotechnology’s hepatitis delta drug pairing, strengthening late-stage antiviral development across Europe, Australia, and New Zealand.

Fondazione and Orphan Therapeutics outline a US access model for Waskyra, highlighting new approaches to manufacturing, distribution, and sustainability.

Targeted integration enables predictable clonal cell lines, enhancing transgene control and accelerating biopharma cell line development.

Charles River has launched a second cohort to speed CGT innovation with technical guidance and scalable manufacturing support.

The third installment of the monthly BioPharma By the Numbers infographic series details batch failure trends in biopharma.

The articles in this issue capture a sector balancing innovation with practicality as it prepares for the next generation of medicines.

Manufacturing biologics is a complex task. Mitigating risk early in the design of manufacturing facilities and the qualification of equipment minimizes future complications.

Flexible manufacturing processes and facilities support the pipeline of allogeneic cell therapies.