Susan Haigney is lead editor of BioPharm International®.
Dyadic and bYoRNA Collaborate on Production of mRNA
The companies plan on targeting the production of abundant, low-cost messenger RNA from C1-cells.
EMA Prepares for Regulation on Health Technology Assessment
The agency’s work with EUnetHTA 21 helped it to prepare the EU for implementation of the regulation.
FDA Issues Guidance on Biosimilar Labeling
The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.
EMA Reviews GLP-1 Receptor Agonists for Self-Harm Risk
The agency is reviewing the medicines after receiving reports of self-injury and suicidal thoughts in patients using the type 2 diabetes treatments.
Gene Therapy for Duchenne Muscular Dystrophy Approved by FDA
The agency approved Elevidys to treat pediatric patients four through five years of age with Duchenne muscular dystrophy.
FDA Sends Warning Letter to Arizona Facility
The agency found insanity conditions and CGMP violations at Pharmedica USA, LLC’s Phoenix facility during an inspection.
FDA Issues Guidance on Pediatric Drugs
The two draft guidance documents provide recommendations for the approval of pediatric drugs, biologics, and vaccines under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act.
EMA Issues Drug Safety Reminders
The agency’s safety committee is reviewing hydroxyprogesterone medicines and issuing a reminder on safety issues regarding fluoroquinolone antibiotics.
EMA Guidance Looks to Prevent Drug Shortages
The agency has published guidance on good practices for securing the supply of medicines.
EMA Publishes Annual Report for 2022
The report outlines highlights from the agency’s medicines evaluations and milestones for 2022.
Communication is Key in Complex Tech Transfer
The complexity of the pharmaceutical product brings challenges to the transfer of information and technology between sponsors and contractors.
Europe Lifts COVID-19 Business Continuity Status
EMA and European regulators are lifting their COVID-19 business continuity measures as the pandemic’s peak ends.
Collaboration Key at the APEC Medical Product Supply Chain Dialogue Event
The event, cosponsored by FDA and USP, hosted regulators and industry leaders to discuss the challenges in strengthening the medical product supply chain.
Scorpius BioManufacturing Announces New Microbial Capacity and New Interim President
In addition to a new interim president, the company is opening new microbial capacity at its San Antonio facility and has plans to construct a commercial-scale facility in Manhattan, Kan.
Outsourcing Still Vital
The bio/pharma outsourcing industry continues to be integral in the development and manufacture of medicines.
Controlling Quality in Aging Facilities
Manufacturing biopharmaceuticals in an aging facility may create quality issues such as equipment breakdown and contamination risks.
The Role of CoAs in Supplier Oversight
Industry experts discuss best practices for certificates of analysis.
Aiding Regulatory Submissions Through Robust Bioanalytical Studies
A thorough understanding of both regulatory requirements and study challenges can help develop and validate the appropriate methods for a bioanalytical study program.
Robust Bioanalytical Studies Can Aid in Regulatory Submissions
It is important to understand regulatory requirements and study challenges to develop and validate the appropriate methods for a bioanalytical study program at the clinical stage.
Automating Packaging of Bio/Pharmaceuticals
Automation of pharmaceutical packaging saves costs and time, say contract packagers.
GMPs for Sterile Manufacturing of Biologics
The complex nature of biologics creates challenges for GMPs in sterile manufacturing, and the EU’s Annex 1 is making an impact.
Fostering Orphan Drugs
CDMOs offer expertise and customization options for sponsors of orphan drugs.
Scaling Up Cell Therapies Capacity
Outsourcing partners are ready to fill the market need for greater cell therapies capacities.
A Robust Quality Culture Benefits All
Establishing a quality culture from the top of an organization down to each and every employee ensures a safe and effective product, and saves costs.
Scaling Up Capacity for Cell Therapies
The booming cell therapy market has created a need for capacity that outsourcing partners are ready to fill.
Technology and CAPA
Performing corrective action and preventive action (CAPA) activities is often necessary to investigate a manufacturing deviation and prevent it from reoccurring. BioPharm International asked Joe O’Gorman, head of Global Operations at LZ Lifescience, a Cognizant Company, about the role technology plays in performing CAPAs.
Supply Chain Considerations for Ensuring Quality
Disruptions in the bio/pharmaceutical supply chain can have serious impacts on the quality and availability of life-saving medicines.
Quality Still a Priority
As regulators balance pandemic tasks and rethink procedures, quality at manufacturing facilities is still a priority.
A New View on Quality Control?
COVID-19 created challenges for quality control departments. How have the lessons learned from the pandemic influenced the way companies use technology to perform quality-control procedures?
The Impact of Insufficient Oversight
BioPharm International asked Vincent Colicchio, vice president, supply chain and external manufacturing at Dr. Reddy’s Laboratories, about how a lack of proper supplier oversight can impact the pharmaceutical industry and the drug supply chain.