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  1. Home
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  3. Frontage Laboratories Opens Fully Operational Gmp Manufacturing Facility
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  • 20 Jan 2026
  • Admin
  • News Article

Frontage Laboratories Opens Fully Operational GMP Manufacturing Facility

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.

Key outcomes:

  • Non-inferior visual acuity versus Eylea 2 mg
  • Comparable fluid control
  • Fewer injections over 64 weeks

Patients receiving Eylea 8 mg required 2–3 fewer injections on average.

Durability Advantage

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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