SITES

Sites

APELOA INTERNATIONAL NETWORK OF SITES

Apeloa Pharma Solutions is dedicated to delivering best-in-class contract discovery, development, and manufacturing services for Starting Materials, Intermediates, and Active Pharmaceutical Ingredients (APIs). With an international network of modern sites, Apeloa CDMO can deliver fully integrated services across a wide range of chemistry types.

R&D CENTERS (CRO SERVICES)

Apeloa R&D sites offer complete CRDMO services to support virtually all discovery and development requirements.

Boston, MA (USA)

16,000 ft2 (1,486 m2)
Library & Technology Development Platform
Capabilities: PROTAC, library for hit to lead, lead optimization, process route scouting, GMP kg Scale-up
Open 2023

Pudong, Shanghai (China)

60,000 ft2 (8,082 m2)
Screening, Library, Process Development
Capabilities: PROTAC, Lab scale Flow Chemistry, Process Development & Optimization, Pilot Production

Hengdian Zhejiang (China)

87,000 ft2 (8,082 m2)
Lead Optimization, Process Development & CMC
Capabilities: Focus on late phase/commercial projects, Core chemistry, Process development & Optimization, Flow Chemistry, Technology transfer

MANUFACTURING SITES (CDMO SERVICES)

Apeloa CDMO manufacturing sites offer a full range of starting material, intermediate, and API manufacturing capabilities. Areas of specialty include flow chemistry, Crystallization, High-potency API (HPAPI), and Core chemistry technologies.

Apeloa Tospo (Shandong, China)

3,229,173 ft2 (300,000 m2)
Chemistry Capacity: 642 m3
RSMs, Intermediates
Capabilities: Dedicated fluorination capabilities
ISO

Shandong Hanxing (China)

5,683,344 ft2 (528,000 m2)
Chemistry Capacity: 5,378 m3
RSMs
Capabilities: Dedicated fluorination capabilities
ISO

Apeloa Kangyu (Zhejiang, China)

4,391,675 ft2 (408,000 m2)
Chemistry Capacity: 1,377 m3
RSMs, Intermediates, APIs
Capabilities: GMP-like Flow Chemistry workshop, Dedicated Hydrogenation workshop, Dedicated Cryogenic Workshop (-80oC)
cGMP

Apeloa Jiayuan (Zhejiang, China)

4,391,675 ft2 (250,533 m2)
Chemistry Capacity: 3,100 m3
RSMs, Intermediates, APIs
Capabilities: GMP Flow Chemistry workshop, Dedicated Hydrogenation workshop, Crystallization and Particle engineering platform

Apeloa Tospo (Zhejiang, China)

4,391,675 ft2 (166,500 m2)
Chemistry Capacity: 632 m3
RSMs, Intermediates, APIs
Capabilities: Focus on antibiotics manufacturing (penicillin, cephalosporin), Dedicated Cryogenic workshop (-80oC)
cGMP

SPECIALIZED CAPABILITIES

High Potency API Facility

Apeloa Kangyu (Zhejiang, China)

Capabilities:

  • High-Potency Laboratory: 400m2 lab for trial & testing
  • High Potency Production Lines: OEB4 and OEB5. (100 g to kg scale commercial production)
  • Dedicated equipment designed only for High Potency use.

Parallel Production CDMO Facilities (302, 303, 304)

Apeloa Jiayuan (Zhejiang, China)

Capabilities:

  • Core Chemistry
  • Flow chemistry
  • 21 segregated bays
  • Auto control design & gravity flow design

BIO-PRODUCTION SITES (CDMO SERVICES)

Apeloa CDMO bio-production sites are equipped to develop and manufacture starting materials, intermediates, and APIs by fermentation or enzyme manufacturing technologies.

Anhui Biotech (China)

6,275,359 ft2 (583,000 m2)
Fermentation Capacity: 1,920 m3
RSMs, Intermediates, APIs
Capabilities: Large Volume of Fermentation Reactors
cGMP

Zhejiang Apeloa Biotech (Zhejiang, China)

1,517,711 ft2 (141,000 m2)
Fermentation Capacity: 3,232 m3
RSMs, Intermediates, APIs
Capabilities: Low Volume Fermentation Products, Enzyme platform
cGMP

FINISHED DOSAGE FORM (FDF) SITES

Apeloa operates finished dosage form sites that support new and generic drug development, technical transfers, and the manufacture of solid oral and parenteral dosage forms, including cephalosporin and penicillin antibiotics.

Hangzhou Zhejiang (China)

Finished Dosage Form (FDF) R&D Center
Capabilities: New drug product team, Generics team, Clinical Team

Hengdian Zhejiang (China)

Headquarters
Finished Dosage Form (FDF) Manufacturing & Marketing
Capabilities: Tech transfer and RA team

Quzhou Zhejiang (China)

Finished Dosage Form (FDF) Manufacturing
Capabilities: Oral & injectables, Cephalosporin and Penicillin antibiotics

OTHER FACILITIES

Process Safety Center

Location: Apeloa Jiayuan (Zhejiang, China)
Certified by Chinese CNAS (authority agency by Chinese government for third party services)
Process Development Equipment:

  • RC1: Used for heat testing for safety and control during scaling up process
  • ReactIR: In-line data collecting
  • EasyMax: Used for reaction condition screening

Apeloa Analytical Testing Center (AATC)

Location: Apeloa Tospo (Zhejiang, China)

  • XRPD
  • 600 MHz NMR
  • LC-MS/MS
  • GC-MS/MS
  • TGA
  • Genotoxic Impurity Software