Manufacturing

The inspection confirmed that the facility was compliant with GMP guidelines.

Integrated data and cloud-based solutions can be used for process optimization.

Asking the right questions is crucial to establishing a biopharmaceutical facility design.

Scale-down modeling accelerates the development of downstream biopharma manufacturing processes.

Analytical laboratory equipment adapts for new realities of downsizing, outsourcing, and speed demands.

Choosing the right facility size requires tailoring the design for current needs as well as anticipating the future.

TxCell’s new facilities are based in Sophia Antipolis, France, on the premises of GenBiotech.

As specialty API outsourcing grows, manufacturers and contract development and manufacturing organizations are investing for the long haul.

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.

The authors provide their perspectives on shipping validation.

Cirrus Pharmaceuticals will launch services for manufacturing cGMP materials for early-phase clinical trials at its Raleigh-Durham, NC facility.

Tablet presses require regular inspection and maintenance to prevent premature wear and tableting problems.

National Bulk Equipment’s material handling system for non-free flowing materials can be specified to meet cGMP cleanability standards.

Pharmaceutical Technology spoke with Franco Negron, president of Drug Product Services at Patheonl, about sustainable technology and reducing energy costs.

Curida entered into a partnership with René Bommer, PhD, founder and owner of pharmAccel Consulting.

Q&A with David A. Steil, pharmaceutical market manager, Camfil Air Pollution ControlPharmTech: Recently there has been an emphasis on green and sustainable technology in the pharmaceutical/biopharmaceutical industries. In what ways does Camfil APC’s technology contribute to sustainability?

Manufacturing of antibody drug conjugates requires high-containment solutions, such as high-performance aseptic isolators.

Regular removal of residues from disinfectants and sporicidals is important for improved aesthetics and safety in cleanrooms.

The course, intended for healthcare professionals, provides an overview of biosimilar products and FDA’s biosimilar product development programs.

Smart glasses enhance remote troubleshooting and process management for pharmaceutical manufacturing.

Near-field communication labels communicate with consumers and support personalized medicine.

Smart glasses enhance remote troubleshooting and process management for pharmaceutical manufacturing.

Biocorp’s Easylog smart sensor for insulin delivery devices enhances compliance.

Innovations awarded at Pharmapack Europe include improvements for patient compliance and protection from errors, tampering, or misuse.

There are no clinically meaningful differences between Celltrion’s CT-P13 and Remicade, according to an FDA briefing released ahead of the formal panel meeting.

The agency prepares a plan to implement new packaging safety features.

When implementing disposable technology for aseptic processing, considerations include material compatibility, material sourcing, facility layout, and training.

AMETEK announced the acquisition of Brookfield Engineering Laboratories, a Massachusetts based manufacturer of viscometers and rheometers.

LabConnect built a biorepository facility in Tennessee.

Common defects in tablet film coating can be minimized by effective design of the tablet core and the coating process.