Tablet Press Refurbishment: Why and How?
Identify the warning signs and follow best practices for refurbishment to improve tablet press yields.
Embracing the Digital Factory for Bio/Pharma Manufacturing
New technologies in the digital factory enhance quality, efficiency, and flexibility for bio/pharmaceutical manufacturing.
Caught in a Conundrum
Do patients get what they pay for when they demand cheaper drugs?
Strategic Screening for Solubility Solutions
Understanding the API, delivery mechanism, and excipient functionality is essential to solving drug solubility challenges.
Monoplant: Advantages of a Dedicated Facility
A monoplant may offer greater supply security and flexibility for specialist medicines.
Handle with Care
Bio/pharma companies facing new challenges in light of the increasing HPAPI market may benefit from outsourcing.
Rising to the Challenge of Biologic Drug Formulation
As biologics continue to push boundaries, the industry needs to take a holistic approach to formulation to ensure success.
Can the Price Ever be Right?
As drug pricing comes under the microscope internationally, it appears that collaboration with all stakeholders is key to tackling the issue.
Europe Pushes for Global Easing of Generics Approvals
The European generics and biosimilars sector is working on the creation of a single pathway to accelerate development of and access to medicines.
Key Considerations in Stability Testing
Harmonization of best practices and regulatory requirements will enable developers to find the best stability testing approach.
Assuring the Safe Handling of Potent APIs, Intermediates, and Solid-Dosage Drugs
Containment valves and smart monitoring can keep employees safe and improve manufacturing efficiency when handling potent APIs, intermediates, and solid-dosage drugs.
Is Simplification Aiding Data Integrity Compliance?
Simplification is crucial to maintain data integrity, according to Siegfried Schmitt, PhD, vice-president, technical at PAREXEL Consulting.
Cell and Gene Therapies Gain Streamlined FDA Oversight
FDA expects more than 200 investigational new drug applications for cell and gene therapies by 2020, causing the agency to strengthen its regulatory program.
CMOs Leading the Way on Single-Use Systems Adoption
Single-use systems can be a cost savings for CMOs, and these savings can be passed on to clients and, ultimately, to patients.
Reinterpreting Benchmarks for Innovative Therapies
While allogeneic therapies can use existing regulatory and quality frameworks, autologous treatments will require pharma’s adoption of true just-in-time and right-first-time concepts, says consultant James Blackwell.
Real-Time Measurement of Coating Film Thickness
Optical coherence tomography can improve quality control and development of coated dosage forms by allowing film thickness to be measured in real time.
Reactor Flask Heating System
The DrySyn UNO Base by Asynt offers a way to conduct safe experiments in academic teaching and research labs.
Pneumatic Conveying System
The Pulse-Flow PTA dense phase pneumatic conveying system from Gericke USA directs air or nitrogen into the pressure vessel and pipeline in timed, regular pulses that form the dry material into separate, wavelike, pulsed slugs.
Floor Mounted Walk-In Fume Hoods
UniFlow FM Fume Hoods by HEMCO are suited for synthesis, distillation, and other rack-type operations where a tall apparatus is used or equipment is rolled into the work area.
Versatile Mixer/Reactor
The VMC VersaMix by Charles Ross & Son Company is suited for temperature-critical formulations of medium to high viscosity under stringent vacuum/pressure constraints.
Pharmaceutical Technology North America, March 2019 (PDF)
Click the title above to open the Pharmaceutical Technology March 2019 issue in an interactive PDF format.
