Bioprocess Engineering & CMC Consulting

Bioprocess Engineering
for Vaccines
and Biologics

Direct technical support across facility design, equipment selection, vendor management, project management, tech transfer, validation, and CDMO oversight — from IND to commercial.

mRNA · LNP · Recombinant · Viral · Inactivated · Conjugates

DS & DP · IND → BLA · Tech Transfer · GMP · CDMO Oversight

Direct technical work, not high-level advice

01

Facility & Equipment Design

Design of GMP manufacturing facilities, layouts, and equipment selection for DS and DP.

02

GMP Facility Construction

Management and oversight of GMP facility construction projects from design to commissioning.

03

Technology Transfer

End-to-end transfer execution, from project initiation to PPQ and closure.

04

Project Management

End-to-end project management for GMP manufacturing projects, from scope definition to on-site execution and closure.

05

CDMO Selection & Oversight

Evaluation, onboarding, and technical oversight of CDMO partners.

06

Clinical & Commercial Manufacturing Support

CMC and operational support to deliver clinical and commercial supply.

07

Process Validation

Equipment qualification from DQ through PQ and process performance execution to support manufacturing readiness.

08

Cleaning Validation

Design and execution of cleaning validation programs in compliance with GMP requirements.

09

CSV — Computer System Validation

Validation of computerized systems in GMP environments, ensuring compliance with data integrity requirements.

10

GMP Readiness & Inspection Support

Preparation for regulatory inspections and GMP compliance.

11

IND / CTD Authoring

CMC documentation for regulatory submissions.

12

Training

Technical training in bioprocess engineering, GMP, and validation.

Modalities & Platform Experience

Deep hands-on experience across the major vaccine and biologic platforms — from upstream process development through commercial manufacturing.

Live Attenuated Vaccines Inactivated Vaccines Inactivated Toxins Sub-unit Vaccines Conjugates Recombinant Proteins Bacterial Systems Viral Vectors DNA mAbs mRNA LNP Sterile Injectables

Japan and Global. No Lost in Translation.

Anyone who has worked on a project between Japan and a global partner knows how difficult the coordination can be. That is exactly where I come in.

Based in Tokyo with fluent Japanese, VaxEng provides direct, in-country support for foreign companies operating in Japan and Japanese companies working with international partners.

Full technical engagement in Japanese, from facility floors to regulatory meetings.

日本のバイオ医薬品産業をグローバルにつなぐ

Facility Construction & Vendor Audits

GMP facility build experience in Japan. Vendor and supplier audits conducted on behalf of foreign companies — in Japanese, on-site, with full technical accountability.

CDMO Research & Selection

Identification and evaluation of Japanese CDMOs for foreign companies entering the market. Conversely, support for Japanese companies selecting and managing CDMOs outside Japan.

Technology Transfer & Project Management

End-to-end tech transfer management in Japan — inbound and outbound. Project management support for manufacturing and CMC programs involving Japanese sites.

Inspection Translation & Business Development

Technical interpretation during GMP inspections (PMDA, FDA, EMA). Business development support for companies seeking partnerships or market entry in Japan.

Biomanufacturing Made Simple

A platform and book series built to make bioprocess engineering and CMC easier to understand, for engineers, scientists, and anyone working in vaccine and biologic manufacturing.

Visit Resource Hub
Articles & technical guides
eBooks & reference manuals
Podcast — articles in audio format
Learning materials for engineers
Templates & frameworks
Hamid Trimech

Hamid
Trimech

Biopharmaceutical Engineer
CMC & Biopharmaceutical Manufacturing Consultant
Business Development · Author

Tokyo, Japan

日本語能力試験1級(N1)  ·  JLPT N1

VaxEng

I am Head of Business Development at ARCALIS Inc., a Japanese CDMO specializing in mRNA vaccines and therapeutics. I grew up in Lyon, France, one of the world's historical centers for vaccine manufacturing, and have been working in vaccine manufacturing and technology transfer for over a decade.

I have worked on more than 15 vaccine programs across France, South Korea, Japan, India, Brazil, Argentina, and Mexico. My experience covers six vaccine technologies: attenuated, inactivated, subunit, recombinant protein, conjugated, and mRNA. I contributed to the delivery of two approved COVID-19 vaccines, one protein-based and one mRNA.

I led the construction of ARCALIS's drug substance manufacturing facility in Japan and managed the technology transfer of a self-amplifying mRNA vaccine from the United States to Japan. Before ARCALIS, I worked at Sanofi Pasteur in the Global Engineering department, managing drug substance manufacturing projects in South America and Asia.

I am fluent in Japanese and have been based in Tokyo for several years. I work comfortably across cultures and am equally at ease on a production floor, in a regulatory meeting, or in a business development context.

I am also the founder of Biomanufacturing Made Simple, a platform where I share knowledge on vaccine manufacturing, and the author of two books on the subject.

10+
Years of experience in vaccine & biologic manufacturing
15+
Vaccine programs across all modalities
13
Countries — France, USA, Japan, Germany, South Korea, India, China, Brazil, Mexico, Argentina, Algeria, Morocco, Tunisia
4
GMP facility constructions led
8
Facility revampings & upgrades
4
PPQs executed
6
GMP inspections supported
2
Books published — Biomanufacturing Made Simple

Also from VaxEng

Biomanufacturing Made Simple

A 2-volume practitioner's guide to bioprocess engineering and CMC — written for engineers who do the work.

View the Book →

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EnjiPro

Document automation software for bioprocess and CMC teams.

Visit EnjiPro →
Get in Touch

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