Angelo Perani, Ph.D

is a recognized biologics and a CMC independent consultant with more than 25 years of experience spanning therapeutic antibody development, biosimilars, cell line development, process development, manufacturing strategy, regulatory affairs, and commercializatio

CMC
BIOLOGICS
THERAPEUTIC ANTIBODIES
BIOSIMILARS
CELL LINE DEVELOPMENT
PROCESS DEVELOPMENT
MANUFACTURING
CDMO MANAGEMENT
TECHNOLOGY TRANSFER
REGULATORY AFFAIRS
FDA
EMA
TGA
COMPARABILITY
ANALYTICAL DEVELOPMENT
CLINICAL MANUFACTURING
BIOPROCESSING
BIOTECHNOLOGY STRATEGY
DUE DILIGENCE
OGTR COMPLIANCE
Contact Details
EMAIL
angeloperani@yahoo.com.au
PHONE
+61 466 877 731
Professional Profile
Angelo Perani, Ph.D, is a recognized biologics and CMC independent consultant with more than 25 years of experience spanning therapeutic antibody development, biosimilars, cell line development, process development, manufacturing strategy, regulatory affairs, and commercialization. He has successfully led biologics programs from early discovery through clinical development and manufacturing readiness, working with biotechnology companies, CDMOs, regulatory authorities, and investors across Australia, Europe, and the United Kingdom.
As Director of Blue Moon Life Sciences and an independent CMC consultant, Angelo advises biotechnology companies on biologics development strategy, CMC planning, manufacturing operations, CDMO selection and oversight, technology transfer, regulatory submissions, and risk mitigation. He currently serves as CMC advisor to Kira Biologics, supporting the development and manufacturing of a therapeutic monoclonal antibody in clinical development.
Career Highlights
More than 25 years of biologics development and manufacturing experience.
Led scientific and CMC activities supporting over 20 biosimilar programs.
Generated more than 30 stable mammalian production cell lines for oncology targets.
Extensive experience preparing regulatory documentation for FDA, EMA, and TGA submissions.
Supported successful advancement of biologics into Phase I clinical studies.
Contributor to development programs for several marketed biologics while at Lonza.

Prior to consulting, Angelo served as Chief Scientific Officer at NeuClone, where he led scientific and CMC activities for more than 20 biosimilar programs. He directed cell line development, process development, analytical comparability studies, manufacturing documentation, and regulatory strategies supporting submissions to the FDA, EMA, and TGA. He also played a key role in advancing NeuCeptin and NeuLara into Phase I clinical trials.

Earlier in his career, Angelo held senior scientific and leadership positions at Lonza Biologics, the Ludwig Institute for Cancer Research, and the Olivia Newton-John Cancer Research Institute, where he developed numerous stable mammalian cell lines and led biologics manufacturing operations. At Lonza, he contributed to the development of several commercially successful biologics, including programs associated withSoliris®, Erbitux®, Vectibix®, Arzerra®, and Orencia®.

In addition to his consulting activities, Angelo serves as an Independent Member of Institutional Biosafety Committees for CSL, Seqirus, and Jumar Bio, providing expert guidance on biotechnology governance and OGTR compliance. His expertise encompasses therapeutic antibodies, biosimilars, CMC strategy, cell line development, process development, technology transfer, manufacturing readiness, comparability studies, regulatory submissions, and biologics commercialization.

Market Segments
Therapeutic Antibody Development
Therapeutic antibody development
Biosimilars Development
Biosimilar development and comparability
CMC Strategy
Chemistry, manufacturing, and controls strategy
Cell Line Development
CHO, NS0, and hybridoma cell development
Bioprocess & Manufacturing Development
Bioprocess and manufacturing development
CDMO Selection & Management
CDMO selection and technology transfer
Regulatory Support
FDA, EMA, and TGA regulatory support
Clinical Manufacturing
Clinical manufacturing and IND support
Biotechnology Due Diligence
Scientific advisory and due diligence
Biosafety & OGTR Compliance
Biosafety and regulatory compliance

Let’s Build the
Right Partnership

API Asia works with manufacturers, laboratories, and industrial operators seeking structured growth, execution, and reliable technical support across Asia-Pacific.

If you are seeking to enhance your process or instrumentation strategy, we are
prepared to collaborate with you.