FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up stakes for manufacturers.
News|Articles|May 15, 2017
- Pharmaceutical Technology-05-15-2017
- Volume 2017 eBook
- Issue 1
Cost Considerations Drive Lean Technology in Biomanufacturing
Author(s)Catherine Shaffer
Manufacturing for originator molecules is restricted by regulations, but drug makers can exploit newer technologies for the manufacture of biosimilars.
Advertisement
The approval of biosimilars for the US market has created a need for more efficient manufacturing processes.
Manufacturers are developing processes for cost efficiency and reliability using newer technology to compete with innovator products manufactured with legacy processes.
Innovations include more productive cell lines, single-use systems, and powerful analytical methods.
Download
.
Articles in this issue
over 9 years ago
Clean, Disinfect, and Validateover 9 years ago
Kill the Bioburden, Not the Biological Indicatorover 9 years ago
Ensuring the Biological Integrity of Raw Materialsover 9 years ago
Getting Biopharmaceutical Tech Transfer Right the First Timeover 9 years ago
Case Study: Retrofitting Two New High-Purity Water Systemsover 9 years ago
Single-Use Bioreactors Have Reached the Big Timeover 9 years ago
Parallel ProcessingAdvertisement
Related to this article
Continuous overall equipment effectiveness can be used to pinpoint hidden downtime and process bottlenecks in real time.
The PharmTech team focused on its coverage of AAPS PharmSci 360 this week, conducting interviews with experts on a range of topics including formulation platforms, AI, amorphous solid dispersions, and animal studies.
Manish Baviskar, Hubot CDMO, on ALCOA++ data integrity, model version change control, continuous monitoring, and human sign-off.
The agreement between CDER and OII with allow for coordinated marketing application assessments and inspections.
Manish Baviskar, Hubot CDMO, explains which AI skills validation engineers need first and why AI model updates must go through GMP change control.
Ron Filler, Drug Development Consultants, explains how USP's 1074 revision brings human-relevant safety science to formulators and excipient makers.
Ron Filler, Drug Development Consultants, explains how USP's 1074 revision brings human-relevant safety science to formulators and excipient makers.
Advertisement
Advertisement
Trending on Pharmaceutical Technology
1
FDA’s New Inspection Playbook Counts Remote Assessments and MRA Reports Toward Facility Evaluations
2
Late-Phase Impurities Need Reference Standards: AAPS PharmSci 360 2026
3
AAPS PharmSci 360 2026: Spray Drying and ASD
4
RRP Accelerated Approval: What VOCERYQ Means for Manufacturing Teams
5