August 11th 2024
Employing novel technologies and more patient-centric approaches can help to reduce the potential of formulation failure.
April 18th 2024
CordenPharma’s partnership with GENEPEP expedites lead development and validation in project phases, and its LNP β-sitosterol supports sustainable emission reduction targets.
February 16th 2024
The need for preclinical testing expertise is growing as molecular complexity increases.
November 2nd 2023
A look at using best practice tech transfer methods for CGTs to increase process and analytics robustness while being scalable.
The new centralized hub will provide advanced testing of nucleic acids, which is expected to simplify mRNA substance testing.
iBio and Aethlon Medical Announce Manufacturing Collaboration
The companies will collaborate to produce and improve the recombinant properties of Aethlon’s Hemopurifier blood purification device.
ABL Acquisition Extends Ardena’s Early-Phase Offering
The acquisition broadens the CDMO’s preclinical and clinical offering to include bioanalytical and drug discovery services.
Catalent and Rutgers University to Study Pediatric Drug Challenges
Catalent Applied Drug Delivery Institute announced a partnership with Rutgers University to examine the challenges of pediatric drug formulation and delivery.
Avantor Opens Research Center in New Jersey
The new center will help biopharmaceutical and pharmaceutical manufacturers with product development.
Catalent Adds Early Development Offerings to OptiForm Platform
Catalent expands the scope of the OptiForm Solution Suite to bridge gap from late-stage discovery to Phase I trials.
CordenPharma, GE Healthcare Partner to Speed Development
GE Healthcare’s Dharmacon business and CordenPharma contract manufacturing enter a strategic collaboration to accelerate the oligonucleotide development process.
Contract Manufacturing Through the Years
How has the bio/pharmaceutical contract manufacturing industry evolved over the years and what does the future hold?
PAT for Continuous API Manufacturing Progresses
Advances in process analytical technology have been achieved, but significant challenges remain.
Wet Granulation Resolves Tablet Reformulation Challenges
A case study reviews the reformulation and scale up of high drug load prototype using wet granulation process for a model formulation.
Catalent to Develop Softgels for Orphan Drug Candidate
Catalent announces a development agreement with JOT to evaluate softgel options for a resveratrol drug candidate.
Lonza Holds Grand Opening of New Drug Product Services Labs
The new facility will focus on formulation development, drug product analytical development, and quality control.
Saneca Pharma Invests in Small-Scale API Capabilities
Saneca Pharma is making significant investment in its API capabilities to support client demand for smaller batch sizes and streamlined scale-up.
Recognizing Pharma Industry Excellence
CPhI Pharma Awards seek nominations for excellence in development and manufacturing.
CMC Biologics and IDT Biologika Collaborate on ADC Manufacturing
Collaboration will provide for unified development and manufacture of antibody drug conjugates.
ADC Risk Vs. Payoff for CMO Industry
PharmSource report addresses how the opportunity for antibody drug conjugates measures up to the bio/pharma industry’s expectations.
Success Story: Transferring a Phytochemical API Portfolio
Sustainable harvesting combined with CMO expertise helped Centroflora CMS ensure supply continuity after it acquired Boehringer Ingelheim's non-captive API phytochemicals portfolio.
Under New Ownership: Consolidation Reshapes Contract Services Market
Mergers and acquisitions have changed the shape of the contract services market as big players seek to build full-service capabilities.
Keeping It Simple: Collaborating for Success in Drug Delivery
For successful partnerships, it’s important to take a long-term view, focus on simple designs, and address potential payer concerns up front.
Novasep Adds Small-Scale Manufacturing Capability to US Facility
Novasep is building a new synthesis laboratory and adding capacity for kilogram-scale batches of synthetic molecules that are needed for biological testing and preclinical trials, at its Pennsylvania, US facility.
Patheon Acquires IRIX Pharmaceuticals
Patheon cites expanded API services with acquisition of IRIX Pharmaceuticals.
Repligen Expands US Manufacturing Facility
A facility expansion adds space for production of Repligen’s tangential flow system.
Novasep to Manufacture Celladon's Mydicar API
Novasep has entered into an agreement with Celladon to provide scale-up and pre-validation studies for the drug substance for MYDICAR.
Minimizing Risk during HPAPI Manufacture
Protecting workers, patients, and the environment requires advanced technologies.
Taking a "Development by Design" Approach to Cell Therapies
Whether outsourcing or developing cell therapies in-house, success demands a focus on quality, cost of goods, and sustainability from the start.
Relationship-building at Top of Mind for Clients
Annual study shows CMO technical expertise is not enough.
Pharma Investments Reflect Key Industry Trends
Shrinking facility size, growth of biologics, and emerging market demand influence pharma investments.
Contractors Invest in Capacity and Capabilities
Contract research, development, and manufacturing organizations invested in new facilities and technologies in 2014 for analytical testing, as well as small- and large-molecule drug development.
Quality by Design in Contract Service Relationships
Contract service providers describe how quality by design has influenced a drug sponsor's expectations of suppliers.
Technologies Key for Biologics to Meet Expectations
Representatives of contract service organizations that develop biologic-based drugs discussed technology trends such as high-throughput screening and single-use systems.
Analytical Labs Strive to Deliver More Information, Faster
Experts from contract testing laboratories and service organizations shared their perceptions of analytical testing advances, and challenges still ahead.