Advanced Manufacturing (Adv Manuf) is a collective term for new medical product manufacturing technologies that can improve drug quality, address shortages of medicines, and speed time-to-market. Examples of some cross-cutting advanced manufacturing technologies include continuous manufacturing and additive manufacturing (e.g., 3D printing).
Product
Good Practice Guide: ATMPs – Equipment Design & Qualification for Cellular Products
Published: October 2025 Pages: 122 Table of Contents Special Pricing for Emerging Economies The…
PE Articles
Industrial ATMP Manufacturing: Digitization’s Role in Aseptic Manufacturing for ATMPs
Over the past decade, Advanced Therapy Medicinal Products (ATMPs) have introduced a significant…
iSpeak Blog
New ISPE Guide: Advanced Therapy Medicinal Products (ATMPs) – Validation Methods and Controls Throughout the Cell and Gene Therapy Lifecycle
Advanced therapy medicinal products (ATMPs) represent a revolutionary frontier in medicine, offering…
PE Articles
Mobile Manufacturing in Pharma Promise, Progress, and Practicalities
Advancements in technology—such as process intensification, continuous manufacturing, and 3D…
iSpeak Blog
Navigating through Advanced Therapy Medicinal Products (ATMPs) Guidance and Regulations
It is not surprising that there are regulations and guidance specifically for ATMPs. However, it may…
PE Articles
Formulation Challenges in Lyophilized Products
Formulation challenges in pharmaceuticals are increasing in complexity due to the rise of…
PE Articles
Volunteer Profile: Krisha Patel, ATMP Community of Practice Co-Chair
Krisha Patel is Co-Founder of Assurea LLC, a digital compliance consulting firm that provides IT and…
PE Articles
Continuous Viral Vector Manufacturing
A growing segment of the advanced therapy medicinal product (ATMP) landscape, which includes gene…
PE Articles
Lessons from a Cost of Goods Analysis Workshop
Advanced therapy medicinal products (ATMPs) are transformative therapeutics that are realizing…
PE Articles
Resilience for Cell Therapy Manufacturers: Five Strategies
For patients who depend on personalized medicine, turnaround time matters. However, moving quickly…
PE Articles
Unlocking ATMPs: Reducing Cost as an Obstacle to Patient Access
Advanced therapy medicinal products (ATMPs) have the potential to treat life-threatening, incurable…
PE Articles
Final Preparation of ATMPs at Point of Care
Advanced therapy medicinal products (ATMPs), which include cell and gene therapy (C>) products…
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Guidance Documents
Advanced Manufacturing (6)
- Good Practice Guide: ATMPs – Equipment Design & Qualification for Cellular Products
- ISPE Guide: ATMPs – Validation Methods & Controls
- Guide: ATMPs - Allogeneic Cell Therapy
- Guide: ATMPs - rAAV Comparability & Lifecycle Mgmt
- Baseline Guide Vol 8: Pharma 4.0
- Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms
Advanced Therapy Medicinal Products (1)
Biotechnology (2)
Data Integrity (1)
Lifecycle Management (1)
Manufacturing Operations (2)
Oral Solid Dosage (1)
Pharma 4.0™ (1)
Quality by Design (1)
Sterile Products (1)
Validation (1)
Pharmaceutical Engineering Magazine Articles
Industrial ATMP Manufacturing: Digitization’s Role in Aseptic Manufacturing for ATMPs
Over the past decade, Advanced Therapy Medicinal Products (ATMPs) have introduced a significant…
Mobile Manufacturing in Pharma Promise, Progress, and Practicalities
Advancements in technology—such as process intensification, continuous manufacturing, and 3D…
Advanced Applications for Digital Twins in Pharma
With the help of Digital Twins, companies can achieve greater certainty and precision in making…
Adoption and Implementation of Innovative Technologies in CMC
The often-overlooked function of chemistry, manufacturing, and controls (CMC) holds tremendous…
A Pharma 4.0™ Future for Brownfield Challenges
Pharmaceutical companies can use digital maturity assessments to address the challenges of upgrading…
Digital Transformation: Developing a Fully Automated Pharma Manufacturing Facility
The move to digital transformation represents a true paradigm shift in manufacturing, enabling…
Lessons from a Cost of Goods Analysis Workshop
Advanced therapy medicinal products (ATMPs) are transformative therapeutics that are realizing…
Resilience for Cell Therapy Manufacturers: Five Strategies
For patients who depend on personalized medicine, turnaround time matters. However, moving quickly…
Final Preparation of ATMPs at Point of Care
Advanced therapy medicinal products (ATMPs), which include cell and gene therapy (C>) products…
The Role of AI and ML in Efficiency and Innovation
The integration of artificial intelligence (AI) and machine learning (ML) into bioprocess…
Artificial Intelligence in Drug Target Discovery
The intersection of AI and drug development has ushered in a transformative era, revolutionizing the…
Guiding Principles for Combination Product Reliability
Drug delivery devices have become an essential component for many modern medical therapies, and it’s…
Webinars
iSpeak Blog Posts
Professional Development Training
ISPE Hands-On Biopharmaceutical Manufacturing Facilities and Processes Training
This course provides a comprehensive understanding of biotech manufacturing processes - what makes biopharmaceutical processes different from small molecules. Course content explores the underlying principles of proteins and cells to provide the foundation for how and why processes manufacture therapeutic proteins. The course studies commonly used manufacturing process operations including cell culture and fermentation; harvest and recovery; viral removal and inactivation; purification processes such as tangential flow filtration, centrifugation, size exclusion, and adsorptive chromatography.
ISPE Hands-On Controlled Production of Drug Substance and Drug Product in Biomanufacturing
This advanced, hands-on training opportunity will implement the global body of knowledge of ISPE to advance the understanding of drug substance and drug product manufacturing, utilizing the commercial scale operational aspects of the Biomanufacturing Training and Education Center (BTEC - located on North Carolina State Centennial Campus in Raleigh, NC) through a series of immersive and hands-on exercises that address current, real world manufacturing challenges.
ICH Q8: QbD in Manufacturing
The ICH Q8 guideline ensures a systematic approach to pharmaceutical development by defining globally recognized Quality by Design (QbD) principles to enhance product quality throughout all stages of development.
Biopharmaceuticals: Webinar C> e ATMP
Biopharmaceuticals: Webinar de treinamento em C> e ATMP Visão geral Este webinar é uma gravação do novo curso de instrutor que é um curso de nível avançado sobre therapies C e Gene T (C>) e Medicamentos de Terapia Avançada (ATMP). O curso também fornece umavisão geral dos componentes mais comuns e estabelecidos que são aproveitados em produtos C> (por exemplo, plasmídeos, mRNA, nanopartículas lipídicas, vetores virais), cobrindo terminologia, processos de fabricação e subsequente caracterização analítica de os componentes fabricados e os produtos terapêuticos. As plataformas de células T…
Biopharmaceuticals: C> and ATMP
Biopharmaceuticals: C> and ATMP Training Course Overview This new instructor lead course is an advanced level course on Cell and Gene Therapies C> and Advanced Therapy Medicinal Products (ATMP). The course provides an overview of the most common and established components that are leveraged in C> products (e.g. plasmids, mRNA, lipid nanoparticles, viral vectors), covering terminology, manufacturing processes and subsequent analytical characterization of the manufactured components and therapeutic products. The adeno-associated virus (AAV) and chimeric antigen receptor (CAR) T-cell…
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