Jennifer Markarian

Advances in digital technologies offer effective data handling for bio/pharma manufacturing.

New technologies improve efficiency and remove operator intervention.

Emergence of advanced manufacturing technology to ensure quality of biopharmaceutical drugs combined with efforts to identify a regulatory pathway indicate that a distributed manufacturing model is within reach.

As new analytical technologies advance, insight into the twin-screw granulation process is growing.

Manufacturers face the challenge of meeting growing demand for personalized biopharmaceuticals.

Machine learning provides real-time data for process control of high-shear wet granulation.

Digital transformation to the Pharma 4.0 paradigm moves forward in process development and clinical and commercial manufacturing.

PAT is crucial to process control and real-time release in continuous manufacturing of solid-dosage drugs.

Unique dosage forms, personalized medicine, and flexible manufacturing are possible with 3DP.

Data analytics, modular equipment, digital tools, and risk-based validation improve speed, flexibility, and quality.

Single-use systems can benefit from standardized risk assessment and analysis protocols, which can facilitate the way in which processing equipment components are compared.

Standardized risk assessment and analysis protocols facilitate the comparison of processing equipment components.

Automation enables intensification of downstream processes.

Automation and digitalization work together in the digital plant.

Precompetitive consortiums seek solutions to industry-wide challenges.

In this episode of the Drug Solutions Podcast, Jennifer Markarian, manufacturing reporter, talks about continuous manufacturing of oral solid-dosage drugs with Lawrence De Belder, executive consultant at Pharmatech Associates, a USP company.

Pharmaceutical Technology spoke with Colleen Floreck, vice president, Global Marketing and Strategy, Catalent Cell and Gene Therapy about the specific requirements and challenges for expanding production of viral vectors.

USP is advancing understanding and developing guidance and standards to assist industry in implementing continuous manufacturing.

Advances in automation and cleanroom technology improve efficiency for small commercial quantities of aseptically filled drug products.

Contract packaging organizations packaging biologic drugs for clinical trials use technologies that meet the unique requirements of each study.

Supply-chain visibility systems are proving their worth in the distribution of COVID-19 vaccines and may see broader use in the future.

Manufacturers of oral solid dose pharmaceutical formulations need PAT tools to reduce a product’s time-to-market and increase profitability.

Continuus Pharmaceuticals is building the first GMP facility using integrated continuous manufacturing technology for end-to-end production of small-molecule APIs and finished dosage forms.

USP is collaborating with Phlow to build a new lab that will develop test methods and standards to facilitate broader adoption of continuous manufacturing.

A digital system makes real-time inventory, production, distribution, and shipping information readily accessible.

Integrated, paperless data systems can improve efficiency and quality.

Collaboration between equipment suppliers and users is leading to innovation and optimization in biopharmaceutical manufacturing.

Collaboration between equipment suppliers and users is leading to innovation and optimization in biopharmaceutical manufacturing.

Pharmaceutical Technology interviewed Cloudleaf about trends in tracking vaccines through the supply chain.

The COVID-19 pandemic has accelerated the need for modular designs to rapidly expand vaccine production capacity.