March 9th 2025
Exosomes, polymeric nanoparticles, and DNA nanostructures offer many potential advantages.
February 25th 2025
The value of outsourcing partnerships for next-gen biotherapeutics rests in the expertise and technologies that service providers bring to the table.
February 13th 2025
This site was previously the beneficiary of a €7.3 million (US$7.6 million) investment, made in 2022, earmarked for the production of HPAPIs to treat cancer.
February 12th 2025
Christian Morello, vice president and head of the Bioconjugates Business Unit at Lonza, looks at what is involved in developing modern ADCs.
February 7th 2025
Increasing API and formulation complexity and new delivery strategies are driving innovations in taste-masking.
CMC Biologics and IDT Biologika Collaborate on ADC Manufacturing
Collaboration will provide for unified development and manufacture of antibody drug conjugates.
Chemometrics Software Expands Use of Raman Analyzer
Thermo Scientific TruTools chemometrics package extends the capabilities of the portable TruScan RM Raman Analyzer.
Regulatory Considerations for Controlling Intermediates in Type-II Drug Master Files for the Manufacture of Generic Drug Substances
The authors present analysis of the state of control of intermediate identity and quality, based on analysis of recently submitted DMFs.
Unifying Excipient Databases
Stephen Hoag, a professor at the University of Maryland (Baltimore), and a member of the National Institute of Pharmaceutical Technology and Education (NIPTE) offers a brief update on issues, and NIPTE’s database project.
Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Asking the right questions is crucial to establishing a biopharmaceutical facility design.
Polymorph Screening for Identification of Relevant Crystalline Forms
Gauging the adequate level and type of screening is the challenge when identifying relevant crystalline forms.
Small-Scale Modeling Boosts Downstream Development
Scale-down modeling accelerates the development of downstream biopharma manufacturing processes.
Technologies Expand Horizons of the Analytical Lab
Analytical laboratory equipment adapts for new realities of downsizing, outsourcing, and speed demands.
Hazardous Reagents for Higher Yields
Hazardous reagents can prove to be faster, simpler, cheaper, and greener.
Kite Pharma Stresses Importance of Cell-Culturing Techniques
The pharma company revealed in a fourth quarter call that it will improve its cell-culture capabilities by focusing on the use of naïve, highly proliferative cells to manufacture its CAR-T drug candidate.
Ashland Facility Achieves EXCiPACT Certification
Ashland Chemical’s Calvert City, KY, facility is the first in the US to receive EXCiPACT certification for GMPs of pharmaceutical excipients.
Going Small to Achieve Commercial-Scale Success
Scale-down modeling is instrumental in supporting the development of downstream biopharma manufacturing processes.
Faster, Cheaper, and Greener
Hazardous reagents can simplify processes and provide higher yields and purities.
International Chemical Trade Association (ICTA) has been founded
The chemical distribution industry has formed an international chemical trade association to address global issues.
Excipient Quality and Selection
Choosing the right excipient manufacturer can help ensure the use of quality excipients.
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.
Lab Services: To Outsource or Not to Outsource
Exploring New Connections in the Lab of Tomorrow
Today’s analytical laboratory equipment reflects the realities of downsizing, outsourcing, and the need for speed.
Emerging Analytical Technologies Advance Biopharma Development
Time and sensitivity are essential for analytical technologies in all phases of biopharma development.
Advances for Bio/Pharma Analytical Laboratories
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.
Onyx Scientific Announces Facility Expansion
Planned expansion at Onyx Scientific add laboratories, GMP suites, and storage space.
A conversation with Centroflora CMS
Andrew Badrot, founder and CEO of Centroflora CMS, discussed the acquisition and technical transfer of Boehringer Ingelheim’s (BI) non-captive phytochemical API portfolio with Pharmaceutical Technology.
Chinese API Manufacturer Zhejiang Hisun Receives Warning Letter
FDA issued a warning letter to Zhejiang Hisun Pharmaceutical Co., Ltd., as a result of inspections that took place on March 2–7, 2015 at the Taizhou City, Zhejiang Province, API manufacturing facility.
Nanotechnology Shows Promise for API Synthesis and Delivery
Nanoscale catalysts and engineered nanoparticles may have a big impact on small-molecule pharmaceuticals.
Expedited Approvals and Orphan Drugs Dominated 2015 Novel New Drugs
FDA approved 45 novel new drugs in 2015, the highest number of approvals since 1996 and second-highest ever.
Collaboration Seeks to Reduce Animal Testing
BASF and Sumitomo Chemical explore in vitro system for chemical safety evaluation.
Mass Spec Lab Announces Official Launch
Mass Spec Lab, a privately owned analytical company, announced its official launch on Dec. 28, 2015 in Southern California.
Boehringer Ingelheim to Establish Biopharmaceutical Production Facility in Vienna
Boehringer Ingelheim announced it will establish a new biopharmaceutical production facility in Vienna.
AstraZeneca Partners with WCPR to Research Secretome
AstraZeneca partners with the Wallenberg Center for Protein Research to conduct studies on the Secretome.