Biologic Drugs

Safe and effective drug targeting with ADCs requires careful selection of drug, antibody, and linker.

Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.

Horizon to make publicly available its complete annotated CHO cell-line sequence in hopes of driving bioproduction cell-line innovation.

FDA advances the progress of biosimilars with acceptance of regulatory filing for biosimilar referencing a blockbuster biologic by Roche.

Manufacturing capacity will be increased by one third and approximately 300 new high-wage and highly-skilled jobs will be created at the Fremont site.

Industry collaboration group releases technology roadmap to address pressure on biopharmaceutical manufacturers to innovate biomanufacturing processes.

The advantages of single-use systems become clear as they become more broadly implemented.

ABEC increases the maximum capacity of its Custom Single Run Bioreactors to 4000 L, doubling the industry standard.

GE Healthcare’s Dharmacon business and CordenPharma contract manufacturing enter a strategic collaboration to accelerate the oligonucleotide development process.

Samsung BioLogics signs $55.5 million agreement to manufacture tildrakizumab for Sun Pharma.

Industry experts discuss the single-use revolution and changes to upstream and downstream processing equipment.

The BIOSTAT STR single-use bioreactor family from Sartorius Stedim Biotech is based on a conventional stirred-tank design.

New ADC therapies must overcome manufacturing challenges to reach market.

As commercial manufacturing considers single-use materials, a look shows how industry moved to the technology.

Biotech-based therapies and a move to single-use processes highlight recent industry changes.

ISPE measures impact of biotechnology and globalization on personalized medicine.

Advancements in cell culture and protein technology have opened the door for new therapies.

Greater transparency and reliability of information are needed in the quality assessments of biosimilars.

BIO report measures decade-long investment and acquisition trends for emerging biotech companies.

Drug sales forecasts fall for first time in 10 years, thanks to pressures to reduce drug prices and the advent of biosimilars.

The landmark decision determined that biosimilar makers can notify manufacturers before receiving FDA approval.

As cost pressures mount as a result of multiple biologics being developed for the same indication, manufacturers can harness process efficiencies to maintain the value of legacy products.

The company will expand its production facilities in Carlow and Cork to meet increased global demand for its medicines and vaccines produced in Ireland.

CBER is moving forward with the development and approval of regenerative medicine advanced therapies.

Ablynx will receive EUR15 million in milestone payment following Merck’s decision to advance ALX-1141 into clinical development. The nanobody was developed by Ablynx under a 2011 collaboration between both parties.

Catalent has signed an agreement with Therachon to support preclinical and clinical development of TA-46, a novel protein being developed to treat achondroplasia.

Understanding the purpose of the biological indicator can guide the development of an effective sterilization process.

A multi-pronged approach to raw materials testing can help mitigate the risk of future contamination events.

The decision to use disposable bioreactors is now driven by commercial rather than technological considerations.

Manufacturing for originator molecules is restricted by regulations, but drug makers can exploit newer technologies for the manufacture of biosimilars.