Manufacturing

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.

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.

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

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.

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.

The new collaboration will aim to streamline formulation-to-manufacturing workflows and de-risk development.

FDA’s internal findings raise new concerns over pediatric vaccine safety and signal potential regulatory shifts affecting future COVID-19 vaccine development.

How is the biopharma industry solving manufacturing and scale-up bottlenecks for cell and gene therapies? Read on to find out.

AstraZeneca’s $2 billion investment in its Maryland facilities will expand domestic biologics and rare disease manufacturing and strengthen US drug supply chains.

Progress in vaccine development is closely tied to advancements in biopharmaceutical technologies, regulatory landscapes, and quality assurance methodologies.

Regulators and manufacturers face new uncertainty as shifting CDC vaccine language raises concerns for evidence-based oversight and biopharma compliance.