August 29th 2025
The authors examine common FDA 483 findings and outline strategies to address and prevent regulatory non-compliance.
The acquisition expands tubular glass vial and ampoule capacity, expanding ready-to-use glass packaging capabilities in Europe.
August 28th 2025
Moderna’s updated Spikevax and mNEXSPIKE COVID-19 vaccines target the LP.8.1 variant of SARS-CoV-2 for high-risk groups and older adults.
The authors propose a streamlined, efficient approach to determining specification equivalence that starts with a paper-based assessment of the methods and progresses to a data assessment for the methods under evaluation.
August 14th 2025
Third-party ICMC certification verifies multi-modality manufacturing readiness, meeting US and EU standards for advanced genetic therapies.
The evolution of therapeutic modalities drives the adoption of single-use technologies.
Horizon Discovery Signs Subscription-Based Licensing Agreement for Biomanufacturing Cell Lines
Horizon announces new bioproduction outlicense deal with an unnamed partner for a minimum value of £500,000.
Researchers Propose a Flexible Method for Gene Therapy Manufacture
Scientists from the Fred Hutchinson Cancer Research Center have developed a semi-automated benchtop system for the manufacture of gene therapy.
Adding Insulin Improves Viral Yield in Vaccine Production
Insulin has been shown to improve the production of viruses and viral vectors.
Oxford Genetics Opens New Facility to Support R&D in Cell and Gene Therapy
Oxford Genetics increased its laboratory space to 5700 sq. ft. with a move to a new location at Oxford Science Park.
Cell Line Quality Technologies
BioPharm International spoke with Selexis CEO and Chairman Igor Fisch, PhD about the latest cell-line development advances.
Data Integrity Challenges in Manufacturing
Designing systems using the principles of good documentation practice, including validated audit trails, is a key piece of a manufacturing data integrity program.
Evaluating Technology and Innovation in Biopharmaceutical Manufacturing
A technology management process identifies and evaluates new technologies in biopharmaceutical manufacturing to aid business decisions.
Plant-Made Pharmaceuticals—Accelerating Drug Development Globally
Plant transient expression offers a flexible approach in drug development and enables rapid production and scale up of therapeutics.
Testing the Broth
Experts discuss recent advances in cell viability testing methods in bioreactors.
Catalent Collaborates with Moderna
The companies will collaborate the manufacture of personalized cancer vaccines.
HHS Sponsors Commercial Manufacturing Tests for Ebola Vaccine
HHS entered into a contract with BioProtection Systems Corp. for commercial manufacturing tests of an Ebola vaccine.
WuXi AppTec Unveils Manufacturing Center for Cell and Gene Therapies
WuXi AppTec’s new biomanufacturing facility is its third facility in the Philadelphia, PA Navy Yard.
Darzalex Combination Shows Promise as Multiple Myeloma Treatment
Results from the Phase III POLLUX trial with Janssen’s Darzalex showed that the drug was effective at reducing disease progression in patients with relapsed or refractory multiple myeloma.
Teva and Celltrion Partner on Biosimilar Commercialization
The companies are collaborating on the commercialization of two biosimilar candidates in the US and Canada.
EUIPO Report Says Counterfeit Medicines Cost EU €10.2 Billion a Year
A report from the European Union Intellectual Property Office shows that the EU loses approximately €10.2 billion a year due to counterfeit medicines.
PDA’s First Aging Facilities Survey Sees Regulatory Obstacles to Modernization
The time and resources required to finalize post-approval changes may be preventing manufacturers from modernizing facilities, or even scouting for new technology.
Multisorb to Build New Manufacturing Facility in India
The company announced that it will build a new manufacturing facility at the GMR Aerospace Park at the Rajiv Gandhi International Airport in India.
Constantia Flexibles Acquires Flexible Packaging Business
Constantia Flexibles acquired a flexible packaging business from Lamp San Prospero SPA.
Xellia Pharmaceuticals Expands R&D in Croatia
Xellia added laboratory space and personnel in Zagreb, Croatia to work on anti-infective products that combat the antimicrobial resistance problem.
Integrated Membrane for Single-Use Filtration Assemblies Saves Set-Up and Validation Time
A PESU membrane is now available for Sartorius Stedim Biotech Sartocon benchtop and production-scale filtration assemblies.
Allergan Enters into Licensing Agreement with AstraZeneca
Allergan entered into a licensing agreement with AstraZeneca for MEDI2070, an anti-IL-23 monoclonal antibody in phase IIB development for the treatment of patients with moderate-to-severe Crohn’s disease.
Children’s Hospital of Pittsburgh of UPMC Receives Grant to Join Vaccine Surveillance Network
The hospital received a five-year $5 million grant from CDC to survey for communicable diseases in children and evaluate vaccine effectiveness.
Boehringer Ingelheim and ViraTherapeutics Collaborate on Oncolytic Virus Therapies
ViraTherapeutics will develop its VSV-GP therapy alone and in combination with other therapies.
PaizaBio Receives CFDA Approval for Expansion
PaizaBio will add aseptic injectable production capacity in Hangzhou, China.
Defining Risk Assessment of Aseptic Processes
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs.
Real Time Continuous Microbiological Monitoring
Laser-induced fluorescence, a rapid microbiology method for real-time airborne particle and microbial monitoring, enhances sterility assurance in pharmaceutical manufacturing.
Optimizing Temperature Control for Biopharmaceuticals
As the pressure to bring drugs to market more quickly increases, companies are faced with the challenge of selecting the most effective cold-chain storage solutions.
HPLE Sugars Improve Stability and Drug Product
High-purity low-endotoxin sugars improve robustness and stability of protein formulation and improve drug product quality.
Multiparticulate technologies hot for controlled release
Multiparticulates are increasingly used due to their flexibility in providing controlled-release, fixed-dose combinations, ease of taste-masking, and suitability for pediatric applications
New Drug-Delivery Methods: From Concept to Patient
Challenging molecules and markets are driving the development of new solutions for drug delivery.