Downloads
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Here's How FDA's Accelerated Approval Pathway Has Evolved Since '24
5/5/2026
FDA's accelerated approval guidance kicked off a rebalancing of new drug approval pathways. Since its 2024 release, the agency has been building on it in a few key areas.
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Development Of An Oncology VHH-ADC Candidate Via Site-Specific Non-Canonical Amino Acid Conjugation
5/5/2026
Homogeneous ADCs demand precise conjugation chemistry. See how 100% ncAA incorporation and 15 g/L titers were confirmed in a VHH nanobody at bioreactor scale.
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Why Dilution Gets Tricky: The Role Of Measurement Variability
5/5/2026
Dilution's effects on downstream processes and final formulation is often understated. A statistical framework can quantify measurement uncertainty's impacts.
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Pfenex Expression Technology® For ncAA-Enabled Site-Specific Conjugation
5/5/2026
Non-canonical amino acids enable site-specific modification of therapeutic proteins by introducing a reactive handle at a defined position. Even so, many ncAA programs stall at the development stage. Off-target toxicity, reduced fermentation yields, and the need for reliable incorporation at scale remain key barriers.
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Gaining An Edge In GLP-1 Production
5/5/2026
The shortage-driven production of GLP-1 drugs of the past few years is giving way to a long-term operation model characterized by digital enablement and supply chain resilience.
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A Liquid Chromatography System With A Wide Operating Range
5/4/2026
Scale purification with confidence using a chromatography platform built for high‑titer, single‑use processes. Wide flow ranges, large columns, and automation‑ready control help reduce changeover time.
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A Novel Cell Selective Lentiviral Platform For CAR-T Engineering
5/4/2026
Targeted lentiviral vectors enable rapid CAR‑T cell generation without extensive ex vivo manipulation. See how this approach demonstrates efficient in vitro and in vivo performance.
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3 Critical UF/DF Challenges And How To Solve Them
5/4/2026
High‑concentration mAbs change how UF/DF behaves. Learn how modern TFF platforms help address these challenges and maintain control as formulations move beyond traditional limits.
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Inside March Biosciences' CD5-Targeting CAR-T Approach
5/4/2026
Fratricide is one of the key reasons T-cell therapies targeting T-cell malignancies have faltered. March's approach aims to solve that with its MB-105 candidate.
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Expanding The Capabilities Of Targeted Integration
5/1/2026
See the demonstration of precise, site‑specific integration of a 50 kb multi‑gene construct into human iPSCs, overcoming size limits of traditional genome‑engineering approaches.