Drug Development

Keith Bader is senior director of technology at Hyde Engineering + Consulting, 6260 Lookout Rd, Suite 120 Boulder, Colorado 80301.

Kelly Jordan is an engineer, at Hyde Engineering + Consulting, 6260 Lookout Rd, Suite 120 Boulder, Colorado 80301.

Richard J. Forsyth is principal consultant with Forsyth Pharmaceutical Consulting, 907 Shamrock Ct, Royersford, PA 19468, tel. 484.535.1688, forsythpharmaconsulting@gmail.com.

Articles

The authors evaluated a variety of materials of construction (MOCs) and found that visible residue limits (VRLs) were higher on some MOCs than on stainless steel. The optimal viewing conditions were dependent on the MOC and the viewing background. The risk of a cleaning failure due to visual failure for different MOCs can be mitigated or eliminated using complementary cleaning validation studies.

Ruggedness of Visible Residue Limits for Cleaning-Part III: Visible Residue Limits for Different Materials of Construction

Shamrock Medical Solutions Group, a drug repackaging and distribution company, repeatedly failed to comply with good manufacturing practices.

Judge Approves Consent Decree Against Shamrock Medical Solutions Group

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

The adoption of quality by design in small-molecule drug development and manufacturing continues to evolve as the industry seeks ways to augment process understanding for APIs

Quality by Design in APIs

Conrad Winters, PhD, is director, Drug Product Development Group, Hovione FarmaCiencia SA.

Filipe Neves, PhD, is group leader, Drug Product Development Group, Hovione FarmaCiencia SA.

Case studies on the manufacture of a bluk powder and the development of a tablet show the application of QbD principles.

Optimizing Quality by Design in Bulk Powders and Solid Dosage

Installation of a quaternary chiral center with high enantioselectivity using memory of chirality enabled the six-step synthesis of the desired active compound.

Takeda Researchers Achieve Kilogram-scale GMP Production of a TORC1/2 Inhibitor

Agencies collaborate to ensure consistent product quality.

FDA and EMA Publish Assessment of QbD for Marketing Applications

CDER withdraws some outdated guidance documents and makes plans to finalize others.

FDA Reviews Outdated Guidance Documents

Successful product development and technology transfer between a CMO and the sponsor company requires a multifaceted collaborative approach. The author, Marga Vines from Grifols International, analyzes a project for an injectable drug for which a new drug application was submitted to FDA.

Optimizing Development, Manufacturing, and Technology Transfer in the Outsourced Relationship

Falsified Medicines Directive requires imported APIs to have written confirmation of GMP standards.

Europe Calls for Guarantee of GMP Standards

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Until recently, glycan analysis has been a slow, labor-intensive process more widely used late in bioprocess development. New high-throughput methods are changing that.

Process and Scaling