Insilica's Dr Thomas Luechtefeld argues process traceability, not benchmark accuracy alone, determines whether AI toxicology decisions can be trusted.
|Articles|March 15, 2002
- BioPharm International-03-15-2002
- Volume 15
- Issue 3
The Importance of Freezing on Lyophilization Cycle Development
Author(s)Thomas W. Patapoff, David E. Overcashier
by Thomas W. Patapoff and David E. Overcashier Genentech, Inc. The freezing method used during lyophilization can substantially affect the structure of the ice formed, the water-vapor flow during primary drying, and the quality of the final product. Controlling how a solution freezes can shorten lyophilization cycles and produce more stable formations.
Advertisement
Articles in this issue
over 24 years ago
Inside Washington: Biotech Manufacturing ? Obstacle or Opportunity?over 24 years ago
Guest Editorial: Warning Letters ? A Symptom?over 24 years ago
Business Benefits of Computer Systems Validationover 24 years ago
A System Developer's Approach to ValidationAdvertisement
Related to this article
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.
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.
Revakinagene taroretcel (Encelto), the only FDA-approved MacTel therapy, slowed photoreceptor loss by up to 54.8% vs sham in phase 3 trials.
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.
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
TaiMed’s Anti-CD4 Antibody TMB-365 Reduces HIV Viral Load in Phase 1, Supporting Long-Acting Combination Regimens
3
Gilead to Buy Oral IL-23R Peptide HCXT-2001 for $1.275 Billion
4
The BioPharm Brief: Gilead’s Oral IL-23R Bet, Roche’s Trispecific Deal, and Treasury’s Biotech Investment Proposal
5