Meeting the Promise of Allogeneic Cell Therapies
Lyophilisation - Key to Overcoming Stability Hurdles for Complex Therapeutics
Beyond Blood Cancers - CAR-T’s Expanding Frontier
Digital Infrastructure for Cell and Gene Therapies
Optimising Clinical Trial Start-Up
EDITORIAL SECTION
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STRATEGY
Smarter Pharma
Quality management systems QMS are the backbone of pharmaceutical manufacturing ensuring safe products
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RESEARCH DEVELOPMENT
Cytiva Laboratory capsule filters
Our singleuse selfcontained filtration solution
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CLINICAL TRIALS
Why Clinical Trials Need Digital Endpoints
According Citeline the average success rate for bringing a Phase candidate to market has dropped to an alltime low of just
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MANUFACTURING
Ensuring Quality and Compliance in Biopharma
Ensuring quality and regulatory compliance in the biopharmaceutical industry is critical to safeguarding product safety and efficacy
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Information Technology
The Cost of Bad Data
Modern pharmaceutical research generates an unprecedented volume of information Data from genomic sequencing
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Biopharma
Reimagining Global Biomanufacturing Capacity with Continuous and Modular Systems
Biotechnology is fueling the ongoing expansion of the global market for a broad array of goods
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EXPERT Talk
Where Technology Thinks Small: AI and Nanomedicine in Harmony
Over the next decade the fusion of nanomedicine and AI will redefine the treatment of neurodegenerative diseases from merely managing symptoms to offering precisionmodifying therapy Smart nanocarriers will be engineered to traverse the bloodbrain barrier target specific brain cells and deliver controlled payloads
Advisory Board
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KNOWLEDGE BANK
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Articles
Implementing Quality by Design (QbD) in Pharmaceutical Development: Enhancing Product Quality and Regulatory Compliance
Quality by Design QbD stands as a systematic strategy for pharmaceutical development prioritizing predefined product objectives and emphasizing a thorough understanding of both the product and its manufacturing processes This proactive approach integrates quality seamlessly into the development process championing a sciencedriven
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Techno Trends
Alkermes Secures FDA Breakthrough Therapy Status for Alixorexton in Narcolepsy Type 1
Alkermes plc has announced that the US Food and Drug Administration has granted Breakthrough Therapy designation to alixorexton for the treatment of narcolepsy type NT
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Projects
FUJIFILM Invests £400M to Expand Biomanufacturing and Process Development Capacity
FUJIFILM Biotechnologies a global contract development and manufacturing organisation CDMO for biologics vaccines and advanced therapies has expanded its site in Teesside UK with a total investment
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Research Insights
Assessing the biopotency of the rAAV9 vector In Vitro
The potency assay is critical to ensure the effectiveness and consistency of recombinant Adenoassociated Virus AAV gene therapy vectors especially clinicalgrade products AAV serotype AAV
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whitepaper
Smoothing the Path to Drug Development with Accurate Clinical Data
Drug development is a long costly and complex process At its core lies a critical question How does a drug affect the bodyand how does the body respond The answers are derived from wellstructured pharmacokinetic PK pharmacodynamic PD
TOP ARTICLES
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1
Brain Delivery of Biologics with Trojan Horse Shuttles: Remembering Paracelsus
William M. Pardridge
The development of biologics for the treatment of neural disorders has been slow, because these large molecule drugs do not cross the blood-brain barrier (BBB). Solutions to the BBB drug delivery prob...
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2
Exploring the Benefits of Bioassay in Pharmacology
Harry Callum
Bioassays, integral to pharmacology, assess drug effects on living organisms. In vitro assays use isolated cells, aiding early drug screening, mechanism understanding, and target validation. In vivo a...
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3
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The Role of Biopharmaceutics in Early Drug Development
Ioan Magyar
This Biopharmaceutics introduces fundamental concepts, methods, and advances in the areas of dissolution, absorption, and permeability and their key applications in dosage form performance. Case studi...
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5
Implementing Quality by Design (QbD) in Pharmaceutical Development: Enhancing Product Quality and Regulatory Compliance
Kate Williamson
This article explores the implementation of Quality by Design (QbD) in pharmaceutical development, emphasizing its principles and practical applications. QbD ensures consistent product quality, reduce...
press releases Read more...
Upperton Submits MHRA Licence Application for Annex 1 Sterile Manufacturing Facility Following APS Validation
Upperton has submitted its application to the UK Medicines and Healthcare products Regulatory Agency MHRA for the approval of its new sq ft sterile manufacturing facility The submission follows the successful execution
Frontage Laboratories Completes Acquisition of Teddy Lab, Strengthening Global Central Laboratory Capabilities
Frontage Laboratories Inc Frontage a leading global CROCDMO today announced the completion of the acquisition of Teddy Clinical Research Laboratory Shanghai Ltd Teddy Lab a leading clinical research
FUJIFILM Biotechnologies Unveils ShunzymeX™ precision purification technology
FUJIFILM Biotechnologies a world leading contract development and manufacturing organization CDMO for biologics vaccines and advanced therapies today unveils ShunzymeX precision purification technology
T-knife Therapeutics Announces Authorization of Clinical Trial Application for TK-6302, A Multi-Armored, CRISPR based T cell Therapy for Solid Tumors
Tknife Therapeutics Inc a biopharmaceutical company developing nextgeneration T cell therapies to fight cancer today announced the authorization of its Clinical Trial Application CTA to begin the Phase ATLAS trial of TK in Europe
Events Read more...
09 - 11
Mar 20268th International Conference
8105, Suite 112, Rasor Blvd, Plano TX 75024, USA
10 - 12
Mar 2026Bioprocessing Summit Europe 2026
InterContinental Barcelona, Spain
10 - 10
Mar 2026Age of AI Europe 2026
Institute of Engineering and Technology (IET) London,UK
10 - 12
Mar 2026Healthcare & Hospi.Log Asia 2026
Singapore
10 - 12
Mar 20269th Annual Pharma Regulatory Summit 2026
Mumbai, India
16 - 17
Mar 2026Pharma USA 2026
Philadelphia, PA, USA
16 - 18
Mar 2026Pharmaceutics and Novel Drug
Kuala Lumpur, Malaysia
16 - 18
Mar 2026Advanced Clinical Research
Kuala Lumpur, Malaysia
LATEST NEWS Read more...
EU Health Package Boosts Biotech and Clinical Trials
The European Commissions Health Package introduces the EU Biotech Act and accelerates clinical trial procedures to enhance Europes life sciences competitiveness
EU Health Package Boosts Biotech and Clinical Trials
The European Commissions Health Package introduces the EU Biotech Act and accelerates clinical trial procedures to enhance Europes life sciences competitiveness
EU Launches Health Package with Biotech Act and Clinical Trial Accelerations
The European Commission has introduced a comprehensive Health Package including the first phase of the EU Biotech Act and amendments to clinical trials regulation to boost competitiveness and resilience in life sciences
Vericel Receives FDA Approval for Advanced Therapy Manufacturing Plant
Vericel Corporation has received approval from the US Food and Drug Administration to begin commercial manufacturing of MACI at its advanced cell therapy manufacturing plant in Burlington Massachusetts
Antengene and UCB Sign Global Licence Agreement for ATG-201 in Autoimmune Diseases
Antengene Corporation Limited and UCB have entered into a global licence agreement for ATG a CDCD bispecific Tcell engager TCE for autoimmune diseases
EU Advances Critical Medicines Act for Supply Chain Resilience
The EU Parliament has advanced the Critical Medicines Act to enhance pharmaceutical supply chain security and resilience across Europe starting in
