Manufacturing

Sandoz, a Novartis division, announced  that the Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions recommending the approval of its biosimilars rituximab and  etanercept in Europe, for the same indications as the respective reference medicines.

The new suite will be used to produce non-sterile dosage forms, such as metered dose inhalers and semisolid topical products, for clinical studies up to Phase II.

The agency is warning about the potential threat of respiratory depression in children who take medicines with codeine or tramadol.

Although technical paths for continuous solid-dosage manufacturing have been laid out and equipment and control systems have been developed, industry is slow to move forward.

Pharmaceutical Technology spoke with Brad Pedrow and Rajesh Singh of Deloitte Consulting to discuss serialization implementation, and what to expect as the DSCSA deadline approaches.

igital tracking of overall equipment effectiveness can improve efficiency.

Cobra will increase capacity in response to customer demand for DNA and viral vector production.

Integrating EBRs with MES reduces time to market, cuts costs, and enhances compliance performance.

Bosch’s new system for the production of water for injection uses membrane processing and ultrafiltration.

The agency issued its recommendation for the influenza virus strains European vaccine manufacturers should include for 2017.

Flexicon’s flexible conduit ranges and hygienic fittings save space and time for power and data installations in pharmaceutical facilities.

Uhlmann Packaging Systems joined the OPC Foundation’s Open Serialization Communication Standard (OPEN-SCS) Working Group.

GE Healthcare continues to ramp up its offerings in the bioprocessing space with the purchase of Asymptote and a continued partnership with Zenith Technologies.

Watson-Marlow Fluid Technology Group’s ASEPCO Weirless Radial diaphragm valves eliminate dead legs and product entrapment.

New study shows China biopharma companies face staffing shortages.

The transfer of fluids is governed by different equipment requirements across the medical, biopharma, and cell therapy manufacturing industries.

Renewable energy can improve energy efficiency and reduce carbon dioxide emissions in pharmaceutical manufacturing processes.

The process control and automation requirements of single-use systems differ from those of stainless-steel equipment.

Anil Kane, executive director, Global Head of Formulation Sciences, Pharmaceutical Development Services at Patheon discusses key parameters in the development and manufacturing of oral solid-dosage forms.

The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics

MDRS differentiates the API from the product matrix and enables measurement of particle size and shape.

As regulators strive for balance in cGMPs for cell, gene, and tissue therapies, risk-management principles must guide decisions involving process media and additives.

Advances in process analytical technology have been achieved, but significant challenges remain.

A chlorine dioxide sterilization cycle was developed for a novel split-valve aseptic powder transfer device.

Soft sensors are powerful tools that can be used along with spectroscopic instruments in on-line measurement.

Continuous manufacturing will not work for all pharmaceuticals, but the right infrastructure, senior management support, and planning from the earliest stages of drug development could eventually allow up to 80-90% of small-molecule APIs to be made continuously, says Paul Sharratt, head of process science and modeling at Singapore’s Institute of Chemical and Engineering Sciences.

A venture between GEA and Siemens aims to familiarize more pharmaceutical companies with more modern control and continuous processing.

This novel technology was developed in response to challenges involved in conventional manufacturing of multilayer tablets, including in-line control of the tablet weight, the tendency to delamination, direct contact between the two tablet layers, and cross contamination.

Process analytical technology, based on monitoring particle size distribution and tracking coating thickness measurements in real time, can be used to predict the dissolution of polymer-coated multiparticulates.

The facility in Britley will now manufacture the company’s automated systems, enabling the company to better serve European markets and shorten the supply chain.