Pharma Matters Q&A: Alfasigma
A Q&A with Rocco Paracchini, director of Alfasigma’s CDMO business unit, about trends in the Italian CDMO market.
Compliance
Covering the latest regulatory news and updates.
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Biologics, Proteins, Vaccines | Breaking News | Industry News | Microbiology | QA/QC
Abzena to Expand Microbiology Lab Space to Support Biologic Manufacturing
Enhances analytical services for antibodies with rapid microbiology release testing and improved scalability through advanced materials separation.10.30.24
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Bioanalytical Services | Breaking News | Drug Development | Industry News | QA/QC
Lonza Completes Drug Product Services Facility Expansion in Basel
Additional capacity supports clinical and commercial manufacture of biologic drug products.10.15.24
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APIs | Process Development | Validation
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Breaking News | Industry News | Information Technology | Validation
Rottendorf Pharma Selects ValGenesis VLMS
Aims to streamline and standardize processes and digitize its corporate validation process.10.08.24
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cGMP Manufacture | R&D | Regulatory Affairs
Sustainability in Pharma: CDMOs Move Fast to Cut Carbon Footprint
Massive overhaul in works to embed greener processes.S. Harachand, Contributing Writer, Contract Pharma 10.01.24
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Biologics, Proteins, Vaccines | cGMP Manufacture | Drug Development | Facilities | R&D | Regulatory Affairs
25th Anniversary Retrospective
Contract Pharma provides a brief look at some key industry topics and changes over the years, what it looked like then and where it is today.Kristin Brooks, Managing Editor 10.01.24
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Regulatory Affairs | Supply Chain
Securing Sustainability Throughout the Pharmaceutical Supply Chain
Engagement is the key to addressing Scope 3.Davuluri Sucheth Rao, Vice Chairman and CEO, Neuland Labs 10.01.24
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Aseptic Processing | Fill/Finish | Parenterals | Regulatory Affairs
Pioneering Production Cell for the Pharmaceutical and Biotech Industry
Vetter and Syntegon join forces to develop Versynta microBatch.Dr. Laura Moody, Director of Product Management Pharma North America, Syntegon 10.01.24
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Information Technology | Regulatory Affairs
Automated Submission Generation: The Next Frontier for Regulatory GenAI?
With some powerful generative AI regulatory use cases now emerging at pace, it’s only a matter of time before the technology will be driving automated submissioTim Wright, Editor 10.01.24
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Regulatory Affairs
FDA Clinical Trial Diversity Action Plan Guidance – What Does it Mean?
Exploring the FDA’s new guidelines to enhance diversity in clinical trials and their impact on the pharmaceutical industry.Susan Shorter, Senior Quality, Risk and Regulatory Compliance Specialist, Greenphire 10.01.24
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Regulatory Affairs
New Risks Discovered as U.S. and EU Drug Shortage Efforts Start to Merge
Navigating emerging threats of drug shortages in the U.S. and EU.Patrick Day, Lachman Consultants 10.01.24
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Clinical Trials | Regulatory Affairs
FDA sIRB Mandate: A Chance to Reassess Site Performance
Characteristics of top performing sites.James Riddle, Senior Vice President, Global Review Operations, Advarra 09.23.24
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Breaking News | Industry News | Information Technology | Validation
Rottendorf Pharma Selects ValGenesis’ VLMS
To implement validation lifecycle management system to digitize its corporate validation process.09.17.24
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Breaking News | Industry News | Regulatory Affairs
U.S. House of Representatives Passes the BIOSECURE Act
Bill would prohibit contracting with certain Chinese biotechnology companies deemed potential national security risks.09.13.24
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Biologics, Proteins, Vaccines | cGMP Manufacture | Regulatory Affairs
Post-COVID Trends in Biopharma Contract Manufacturing
Industry is shifting back to previous long-term growth trends.Ioanna Deni, Research Scientist and Market Researcher, BioPlan Associates 09.05.24
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cGMP Manufacture | Drug Development | GMPs/GCPs | Parenterals | Regulatory Affairs | Solid Dosage/Creams/Ointments
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Biologics, Proteins, Vaccines | cGMP Manufacture | GMPs/GCPs | Regulatory Affairs | Scale-up/Technology Transfer | Validation
A Molecule’s Journey: Break Down Roadblocks to Commercial Manufacturing Success
In this guidebook, experts share key considerations for biopharmaceutical companies as they advance their antibody drug to commercial manufacturing.
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Chemistry | Validation
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Biosimilars | Breaking News | Industry News | Regulatory Affairs
Tanvex BioPharma USA Achieves Dual U.S. Regulatory Milestones
FDA approves Nypozi and grants BLA acceptance of TX-05.08.30.24
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APIs | QA/QC
Impurities in APIs and Their Effects on Products
Risk assessment approaches, employing appropriate control strategies, and robust analytical methods can ensure high-quality and safe medicines.Bryan Tackett, PhD, Phenomenex 07.29.24
