Manufacturing

Solid-phase extraction has several advantages over liquid/liquid extraction for extractables and leachables studies.

Avid, a wholly owned subsidiary of Peregrine Pharmaceuticals, will upgrade its Myford, California clinical and commercial manufacturing facility with multiple Mobius 2000-L single-use bioreactors from MilliporeSigma, the companies announced on May 1, 2017.

The type of water for pharmaceutical use is determined by USP testing.

Innovative new technologies released over the past several months seek to enhance bio/pharmaceutical development and manufacturing.

Companies believe that biologics and biosimilars would experience the fastest growth over the next year; there is also interest on increasing market penetration of generic drugs.

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.