Digital Journal

How biologics CDMOs are shaping early-stage drug development strategy?

Opinions expressed by Digital Journal contributors are their own. Bringing a new biologic drug from concept to clinic is a complex journey fraught with technical and regulatory hurdles. For ...

Dark Horse Consulting Group and Altruist Biologics Announce Memorandum of Understanding to Advance Biologics Manufacturing and Development in China

This partnership unites DHCG’s comprehensive regulatory, CMC, nonclinical, clinical, quality & compliance, supply chain, commercial launch, and business analytics consulting capabilities with Altruist ...
Morningstar

Earendil Labs and WuXi Biologics Enter Strategic Collaboration to Accelerate Development and Manufacturing of Bispecific/Multispecific Antibodies and ADCs

WILMINGTON, Del., March 12, 2026 /PRNewswire/ -- Earendil Labs, a global leader in AI-driven research and development of next-generation biologics therapeutics, and WuXi Biologics (2269.HK), a global ...
Business Wire

Cytovance Biologics Expands Services With In-House Formulation Development

OKLAHOMA CITY--(BUSINESS WIRE)--Cytovance Biologics, a U.S.-based Contract Development and Manufacturing Organization (CDMO), announced the launch of its in-house formulation development services, ...
TMCnet

AGC Biologics to Manufacture Teikoku Seiyaku's rhMMP-7 Drug Substance

AGC Biologics, your friendly CDMO expert, was selected by Teikoku Seiyaku Co., Ltd., a leader in transdermal drug delivery, to provide microbial contract development and manufacturing services for KTP ...
Nasdaq

HCW Biologics and WY Biotech Finalize Licensing Agreement for HCW11-006, Marking Strategic Development Partnership

HCW Biologics Inc. and WY Biotech Co., Ltd. have finalized a licensing agreement for the development and commercialization of HCW11-006, a novel immunotherapy targeting age-related diseases and cancer ...
GEN

What’s Next in the Evolution of Standards for Biologics Development

Documentary standards such as monographs, general chapters, and reference standards are essential for efficiently meeting regulatory requirements and ensuring the intended efficacy and safety of drugs ...
Business Wire

AGC Biologics Expands Cell Therapy Development Operations to Asia to Serve Growing Market Need

TOKYO--(BUSINESS WIRE)--AGC Biologics, your friendly CDMO expert, will commence cell therapy process development and clinical manufacturing services on July 1, 2025, at AGC Inc.’s Yokohama Technical ...
News-Medical.Net

Building quality into drug development for safer, faster medicines

Discover how quality-driven drug development and AI accelerate safer medicines, reduce risk, and improve patient outcomes.
The Scientist

Understanding the Drug Development Process

Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...
Hosted on MSN

FDA To Streamline Approval Process For Generic Biological Drugs

The U.S. Food and Drug Administration (FDA) announced on Wednesday (October 29) a plan to streamline the approval process for biosimilars, which are generic versions of complex biological drugs. These ...