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.
PPD Launches IPO
Drug development contract services company PPD announces initial public offering.
Charles River Laboratories to Acquire HemaCare in $380-Million Deal
The acquisition expands Charles River’s scientific capabilities in cell therapy development.
Cambrex Sale to Premira Funds Affiliate Closes
Cambrex reports that the acquisition by the investment group will facilitate ongoing growth.
Catalent to Supply BeiGene’s Brukinsa
The companies announced a commercial supply agreement following FDA’s accelerated approval.
Thermo Fisher Scientific Expands Capabilities
New training facilities, laboratories, packaging, gene therapy manufacturing, and biologics manufacturing highlight Thermo Fisher Scientific expansions.
Particle Sciences Rebrands as Lubrizol Life Science Health
Lubrizol Life Science Health adopts new name and opens commercial manufacturing facility.
Lonza, Genmab Extend Drug Development Partnership
Lonza, through its Ibex Solutions, will now cover preclinical and clinical development and manufacturing for a significant portion of Genmab’s pipeline.
Stability Testing for Small-Molecule Clinical Trial Materials
Limited guidance and numerous challenges create confusion about the scope and timing of stability testing for drugs in development.
Uncovering Hidden Risks in Solid-State API Properties
An understanding-during early development-of the solid form landscape of an API can enhance product quality and manufacturing processes.
Market Dynamics Drive the Agenda for CPhI Worldwide
New therapies, new technologies, global supply chain challenges, and political pressures draw pharma professionals to major industry event.
Taiwanese CDMO Gains FDA Approval for Zhunan Facility
Bora Pharmaceuticals has announced it has achieved success in the latest FDA general inspection of its Zhunan facility with zero 483 observations.
Pharma Contract Market Update
CMOs and CDMOs expanded their services and facilities in the summer of 2019.
Partnering Up for Success
To help customers succeed, CDMOs have moved away from the ‘fee-for-service’ model to offer flexible, full-service partnerships.
In Safe Hands
Complex and potent molecules demand greater technical and regulatory expertise to ensure safe handling.
Catalent Extends Spray Drying Capabilities in Europe
An agreement with Sanofi gives Catalent access to commercial spray drying facility in Haverhill, UK.
Piramal Pharma Solutions Invests $10 million to Expand HPAPI Capability
The company has expanded its high-potency API capability at its Riverview, MI, facility to serve the growing antibody drug conjugates market.
Lonza Expands HPAPI Capacity
Two additional production lines expand Lonza’s HPAPI capacity at Visp, Switzerland facility.
Tergus Pharma Plans Commercial Manufacturing Facility
Tergus Pharma announced a partnership with Great Point Partners and construction of a new commercial manufacturing facility in North Carolina.
Particle Sciences Gains DEA Schedule I Registration
Expanded controlled substance capabilities enables Particle Sciences to develop and manufacture Schedule I–V drugs.
WuXi Biologics to Build New Manufacturing Center in China
The company announced plans to construct a 1.3 million-ft2 integrated manufacturing center in Chengdu, China.
Recipharm Launches Development and Manufacturing Service for Inhalation Products
Recipharm Inhalation Solutions is an integrated service for inhalation products.
Samsung BioLogics, GI Innovation Partner on Immunochemotherapy
Samsung BioLogics will provide contract development organization services to drug developer GI Innovation.
Integrated First-in-Human Service Package for Poorly Soluble Small Molecules
Lonza’s SimpliFiH Services addresses bioavailability challenges with drug substance, solid-state characterization, and drug product for first-in-human studies.
Catalent Invests $14 Million at Softgel Facility in Germany
Expansion at the Eberbach, Germany facility includes two Vegicap encapsulation lines, printing, inspection, and packaging capabilities.
Vetter’s Illinois Facility Expansion Nears Completion
The expansion of the CDMO’s Skokie, IL facility includes additional refrigeration and freezer space.
Protagen Protein Services, BioAnalytix Merge into CRO
The companies will merge to offer a broader range of analytical data packages and regulatory support for biopharmaceuticals.
Catalent to Acquire Paragon Bioservices for $1.2 Billion
Catalent’s acquisition of Paragon Bioservices will provide expertise and in expanding gene and cell therapy markets.
Precision NanoSystems Launches Clinical Solutions Service
The new service offers a flexible, customizable suite of products and services designed to accelerate the clinical and commercial development of gene and cell therapies.
Sterling Pharma to Acquire CiVentiChem’s US Facility
The acquisition of CiVentiChem’s facility in the United States is expected to enhance UK-based Sterling Pharma Solutions’ chemistry development capabilities.
Catalent Expands HME Capabilities
Catalent invests $5 million in hot melt extrusion capabilities at Somerset, NJ facility.