Frontage Laboratories announced that its new GMP manufacturing facility is now fully operational. The site opened in May 2025 and completed GMP validation in October 2025.
What the Facility Supports?
The facility is designed for drug development, clinical manufacturing, and commercial production. Key capabilities include:
Sterile manufacturing for vials, syringes, and cartridges
Oral solid dosage forms including tablets and capsules
Liquid dosage forms, ointments, and gels
High-potency compound handling with containment suites
Infrastructure and Technology
The site includes ISO-classified GMP rooms, analytical labs, and microbiology laboratories. New equipment installed includes:
Three automated aseptic filling lines
Two new isolators for potent compounds and aseptic filling
Gerties roller compactor
Korsch tablet press
Xcelodose system
Integrated labeling systems
Why It Matters?
The expansion supports:
Clinical Phase III manufacturing
Process Performance Qualification (PPQ) batches
Small-scale commercial production
These additions reduce development timelines and improve manufacturing efficiency.
Leadership Commentary
Dr. Song Li, Chairman of Frontage, highlighted faster time-to-market and end-to-end support as core benefits.
About Frontage
Frontage Laboratories is a US-based global CRDMO with over 25 years of experience.
The company operates 26 sites worldwide and supports regulatory approvals across major global markets.
EU Approves Eylea 8 mg for Retinal Vein Occlusion
Regulatory Milestone
The European Commission approved Eylea 8 mg for macular edema following retinal vein occlusion. This includes branch, central, and hemiretinal vein occlusion.
RVO is now the third approved indication for Eylea 8 mg.
Clinical Need
RVO often causes sudden vision loss in older adults who remain professionally active.
Frequent injections create a high treatment burden for patients.
QUASAR Trial Highlights
In the Phase III QUASAR study, Eylea 8 mg met its primary and key secondary endpoints.
More than 60% of patients reached treatment intervals of four months or longer. Forty percent achieved five-month intervals by study end.
Safety Profile
Eylea 8 mg was well tolerated. Its safety profile matched results from previous clinical trials.
Strategic Impact
The approval expands Eylea 8 mg’s EU indications to:
Wet age-related macular degeneration
Diabetic macular edema
Retinal vein occlusion
Eylea 8 mg remains the only anti-VEGF approved for dosing intervals up to six months in the EU.
Elanco Receives USDA Approval for TruCan Ultra B (Oral)
Approval Update
Elanco announced USDA approval for TruCan Ultra B (Oral). The vaccine protects dogs against Bordetella bronchiseptica.
What’s New?
TruCan Ultra B delivers the same protection as TruCan B Oral in half the volume. Lower volume improves comfort during vaccination.
Technology Behind the Vaccine
The vaccine uses PureFil Technology. This technology:
Removes unwanted protein and debris
Reduces adverse reactions
Improves the in-clinic experience
Clinical Evidence
TruCan Ultra B demonstrated:
Safety across dogs aged 4 weeks to 15 years
A 93% preventable fraction in challenge studies
The vaccine significantly reduced Bordetella-associated coughing.
Market Demand
Research shows 99% of pet owners value low-volume, highly purified vaccines. Comfort during vaccination is now a priority.
Portfolio Expansion
This marks the second Tru vaccine expansion in 2025. TruCan Ultra CIV H3N2/H3N8 was approved in July 2025.
Industry Endorsement
Elanco’s Tru vaccine line is the first portfolio recommended by Fear Free. The vaccine is expected to launch in Q1 2026.
About Elanco
Elanco is a global animal health leader serving pets and farm animals worldwide. The company focuses on innovation, disease prevention, and veterinary care excellence.
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