Zylidac will test whether optogenetic cell lines that hit 21 g/L in small-scale CHO runs can deliver higher-yield complex biologics at GMP scale.
|Articles|May 15, 2017
- BioPharm International-05-15-2017
- Volume 2017 eBook
- Issue 1
Getting Biopharmaceutical Tech Transfer Right the First Time
Author(s)Agnes Shanley
Good project management, budgeting, planning, and clear documentation are the only ways to prevent overruns and project failure.
Advertisement
Biopharmaceutical experts Stephen Perry, CEO of Kymanox, James Blackwell, principal consultant with The Windshire Group, and consultant Mike Ultee, share best practices and musts to avoid in biopharmaceutical technology transfer. Some crucial takeaways? Share all data (especially data on failed runs in the past), and include clear instructions for sampling. In addition, aim for reproducibility.
Articles in this issue
over 9 years ago
Customer Relationship Management in Contract Manufacturingover 9 years ago
CMOs Tackle New Challengesover 9 years ago
Gearing Up for Biosimilarsover 9 years ago
Insourcing vs Outsourcing: Choosing the Right Strategyover 9 years ago
Operations and Quality Oversight of CMOsover 9 years ago
Quality Metrics and CMO AgreementAdvertisement
Related to this article
Rohit Tripathi, vice president of industry strategy, consumer packaged goods, and manufacturing at RELEX Solutions, explains what is driving biopharma reshoring, how USMCA uncertainty complicates sourcing for biologics, and where cold-chain visibility still breaks down.
Backed by €400 million (US$449 million) in EU-cleared German aid, the new Frankfurt facility is designed to secure insulin supply for people with diabetes from 2032.
Insilica's Dr Thomas Luechtefeld argues process traceability, not benchmark accuracy alone, determines whether AI toxicology decisions can be trusted.
Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about the regulatory and manufacturing hurdles facing rare disease drug developers.
Rohit Tripathi, vice president of industry strategy, consumer packaged goods, and manufacturing at RELEX Solutions, explains where cold-chain planning still breaks down and why biopharma supply chain leaders should use AI to act on data sooner, with humans making the final call.
Revakinagene taroretcel (Encelto), the only FDA-approved MacTel therapy, slowed photoreceptor loss by up to 54.8% vs sham in phase 3 trials.
EA2251, the 7th registrational trial of ivonescimab, will test it plus chemotherapy vs pembrolizumab or durvalumab regimens in first-line BTC.
Advertisement
Advertisement
Trending on BioPharm International
1
Treasury Proposes Adding Biotech to Outbound Investment Restrictions Under COINS Act
2
FDA Approves On-Body Injector Induction for Skyrizi in Crohn's Disease
3
The BioPharm Brief: Gilead’s Oral IL-23R Bet, Roche’s Trispecific Deal, and Treasury’s Biotech Investment Proposal
4
Zymeworks Licenses DLL3-Targeted Trispecific T-Cell Engager ZW209 to Roche in Deal Worth Up to $813 Million
5