Formulation Development
FORMULATION DEVELOPMENT WHITE PAPERS & ARTICLES
-
Peptide Building Blocks: Navigating Quality, Supply, And Scale
Non-canonical amino acids can boost peptide half-life and potency, but create challenges in impurity control, GMP classification, and sourcing. Early supplier choices are critical for commercialization.
-
Accelerating Complex Generic Drug Development Through Advanced Deformulation
With FDA no longer identifying Q1/Q2 differences, applicants bear the diagnostic burden. Reverse engineering now directly affects development speed, cost, and approval.
-
Why Audit Success No Longer Predicts Clinical-Stage Performance
Passing inspections no longer signals that a growth-stage biotech can sustain clinical-stage complexity. The gap between audit readiness and operational readiness opens quietly.
-
Practical Formulation Strategies For Poorly Soluble APIs
Poor aqueous solubility now defines most drug candidates in development, making early screening and solid-state assessment essential to achieving reliable exposure and avoiding costly reformulation downstream.
-
The Art Of Protein Expression: A Guide To Understanding Difficult-To-Express Proteins
Protein expression failures often result from misfolding, PTMs, assembly issues, insolubility, and toxicity. Understanding their interplay can improve yields.
FORMULATION DEVELOPMENT APPLICATIONS & STUDIES
-
Reducing Cycle Time By 88% Through Strategic Solvent Replacement In Pharmaceutical Development
Replacing methylene chloride in a slow, labor-intensive API step led to a single-solvent, one-pot process with a shorter reaction time and improved yield and purity.
-
Improving Stability Through Science-Led OSD Reformulation
A marketed multivitamin tablet spanning a 0.03% to 46% w/w range failed early in accelerated stability testing. Mechanism-led reformulation and a switch to direct compression changed the outcome.
-
De-Risking Complex Generic OSD Development
Complex generic tablet development requires early alignment of regulatory strategy, QbD formulation, discriminatory dissolution, and reference-scaled bioequivalence.
-
Formulation And Process Challenges For A Needle-Shaped API
Managing challenging active pharmaceutical ingredient crystal structures and choosing dry granulation over wet granulation requires strategic processing choices.
-
From Sequence To Scale In Seven Months
Accelerate recombinant protein development from sequence to scale while maintaining stable expression, manufacturing efficiency, and critical quality attributes.
FORMULATION DEVELOPMENT SOLUTIONS
- High-Throughput Cellular Screening System
- Multi-Mode Microplate Reader
- Discovery Hybrid Rheometers: Temperature Systems And Accessories
- Customizable Imaging Workstations
- Compact And Tunable Absorbance Microplate Readers
- HPLC Made For Tomorrow
- Develop. De-risk. Deliver.
- Early Development: Accelerating Molecules Through To Proof-Of-Concept
- The Digital Suite For Process Lifecycle Intelligence
- A Rapid Workflow For High‑Resolution Protein Analysis
PHARMACEUTICAL AND FORMULATION DEVELOPMENT NEWS
- Hapman To Unveil New Conveying Solution At PACK EXPO 2026
- Pharmaceutical Online Covers Honorable Mention FOYA Award Winner, Chugai Pharmaceutical Co., Ltd.
- Emerson Expands Life Sciences Scheduling Software To Optimize Quality Control Lab Testing
- GSK Announces Drug Manufacturing Expansion In Pennsylvania
- Contec Launches Sterile ReadySAT™ With PeridoxRTU® Sporicidal Wipes For Cleanrooms
- Upperton Unveils New Brand Identity Reflecting Evolution Into Specialist CDMO
- Hovione To Commission World's First ConsiGma® CDC Flex, Bringing Next-Generation Continuous Tableting To The U.S.
- Agilent Expands Oligonucleotide Manufacturing Capabilities With New Boulder Lab
- Flamma Acquires API Manufacturing Site In Padova, Italy
- Bayer Expanding U.S. Pharmaceutical Manufacturing Footprint With New Ohio Manufacturing Facility