Antibody FcEffector Function
This paper compares ADCC, ADCP, CDC, FcγR binding, C1q binding and FcRn binding across five practical dimensions: biological mechanism, assay …
White Papers
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Curia’s Approach to Regulatory Compliance in China
This whitepaper examines China’s regulatory framework for active pharmaceutical ingredients, covering Chinese DMF submission and translation, NMPA and CDE review, …
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Curia’s Approach to Regulatory Compliance in Korea
This whitepaper examines Korea’s regulatory framework for active pharmaceutical ingredients, including K-DMF submission and maintenance, foreign manufacturer registration, Korean GMP …
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Curia’s Approach to Regulatory Compliance in Japan
This whitepaper provides an overview of Japan’s regulatory requirements for active pharmaceutical ingredients, including J-DMF registration, Foreign Manufacturer Accreditation, Japanese …
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Curia’s Approach to Regulatory Compliance in Brazil
This whitepaper explores Brazil’s evolving regulatory framework for active pharmaceutical ingredients, including the DIFA and CADIFA system, ANVISA GMP requirements, …
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Intellectual Property Considerations in Drug Development for Biotech Companies
This whitepaper explores how biotech companies can incorporate intellectual property considerations into drug development. It covers IP landscape analysis, prior …
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Flying on two Wings: Ypsomed’s Dual-Engine Strategy for Success in China
Hong Cui, Orfeo Niedermann and Shawn James of Ypsomed discuss how their company has succeeded in China, highlighting the importance …
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Interview: Enhancing Clinical Trials with CliniPilot® and Clear to Clinic™ Programme
Today, pharma companies are aiming to accelerate clinical development for faster time to market without compromising on data quality or …
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Beyond Drug Delivery: Three Lenses for Selecting an On-Body Platform
Reto Jost, Nadine Kaufmann and Shawn James, all of Ypsomed, discuss three complementary decision lenses and explain how they offer …
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Bio-Based Plastics in Drug Delivery: From Material Equivalence to Systemic Decarbonisation
Nadine Kaufmann and Michael Schori of Ypsomed analyse the feasibility of introducing sustainable materials within current regulatory frameworks, demonstrating this …
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GxP Compliance for SaaS Applications: A Practical Guide for Pharmaceutical, Biotech and Medical Device Organisations
Pharmaceutical, biotechnology and medical device companies face a recurring challenge: determining whether a Software as a Service (SaaS) platform is …
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Sterile Filtration of Budesonide as a Preferred Sterilisation Strategy
Sterile budesonide manufacturing requires a sterilisation strategy that protects both chemical integrity and critical quality attributes. Because the molecule is …
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Continuous Manufacturing: A Novel and Enabling Tool to Overcome API Batch Manufacturing Limitations
While batch processing remains the dominant manufacturing approach for pharmaceutical APIs, continuous manufacturing is increasingly being adopted to address challenges …
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Next-Generation CAR-T Design: Overcoming TME Barriers with Armoured Payloads and Logic-Gated Precision
Solid tumours are not “harder blood cancers.” They are engineered ecosystems—mechanically fortified, metabolically hostile, and immunologically suppressive. Next-gen CAR-T success …
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From Autologous to Universal: Efficiency Strategies to Accelerate Next-Generation Immune Cell Therapy (CAR-NK/iPSC) R&D
Cell therapy is entering a phase where operational efficiency is becoming as decisive as scientific novelty. Autologous CAR-T has demonstrated …