Susan Haigney

The COVID-19 pandemic has created a rise in demand for R&D and a shift in focus for some contract organizations.

A contamination control strategy can prevent contamination in sterile product manufacturing. The right system, equipment, and personnel training are also essential to mitigate risk.

Pharmaceutical Technology spoke with John Harmer, director, technical sales at Vanrx Pharmasystems about considerations in choosing the best system and equipment for contamination control in pharmaceutical manufacturing.

Pharmaceutical Technology spoke with Jens Andersson, purchasing director at Cambrex Karlskoga, about the best way to ensure the security of the bio/pharmaceutical materials supply chain.

Risk assessments, audits, and good communication between sponsor and supplier are key elements of supplier oversight.

CDMOs and CMOs will continue to invest in biopharmaceutical services and facilities as the bio/pharmaceutical industry looks to biosimilars and personalized medicine.

An effective quality control unit is independent from manufacturing and ensures current standards are followed.

Unforeseen challenges can be avoided in technology transfer by evaluating the variety of processes involved.

Contract manufacturers are making strategic partnerships and expanding services in the last quarter of 2019.

CDMOs are adding facilities and services to their portfolios in anticipation of the biologics industry’s continued growth.

Does the pharmaceutical industry have adequate access to contained equipment, facilities, and infrastructure for the manufacture of highly potent APIs?

The increasing growth in the cell- and gene-therapy markets is inspiring CDMOs to expand their services in this emerging biologic drug arena.

Pharmaceutical Technology spoke with Roger Croucher, senior manager, R&D projects, at Catalent Pharma Solutions; Daniel M. Bowles, senior director, chemical development, at Cambrex; and Kurt J Kiewel, director, new product development and analytical services, also at Cambrex about best practices for a successful technology transfer.

Outsourcing of analytical testing and processes can help bio/pharmaceutical companies expand their product profiles.

Pharmaceutical Technology spoke with John Pirro, senior director of large molecule bioanalysis at WuXi AppTec, which provides anti-drug antibody (ADA) and neutralizing antibody (Nab) assay development, validation, and sample analysis services, about best practices to ensure that biologics are safe and effective.

Pharmaceutical Technology spoke with Lisa Crandall, MS, associate director CMC Project Management, and Peter Angus, PhD, director of Pharmaceutical Sciences, at Velesco Pharma, which provides a full range of stability testing of API and drug products, about best practices in stability testing.

Shortages of life-saving drugs are a regulatory and industry concern. Proper process development may help to ensure drug supply.

CMOs and CDMOs made investments in new and expanded facilities and services in the last quarter of 2018.

FDA Commissioner Scott Gottlieb has been promoting drug market competition in recent months that includes new guidance documents and targeted advisories to support R&D of complex drugs and combination products.

Industry experts discuss the formulation and development issues that should be considered when addressing scale up from small-scale batches to commercial production.

Considering the challenging nature of performing glycan analysis, what are the benefits of outsourcing glycan analysis for sponsor companies?

Industry experts discuss the challenges of performing glycan analysis and how companies can gain specific expertise from outsourcing partners.

Pharmaceutical Technology spoke with Sharon Ayd, executive vice-president of Pre-approval Pharmaceuticals and chief scientific officer at Regulatory Compliance Associates, about developing a corrective action and preventive action (CAPA) plan.

Maintaining good quality control practices throughout the entire manufacturing process requires robust development, a drive toward product and process understanding, and pre-established, comprehensive written procedures that are consistently reviewed and updated.

Robert Iser of PAREXEL Consulting answers questions regarding the regulatory expectations of quality agreements and how companies can ensure the quality and safety of their products.

Process validation is an extension of biologics development processes.

In a productive year, 2017 was filled with acquisitions, facility expansions, and new biopharma technology.

In a productive year, 2017 was filled with acquisitions, facility expansions, and new biopharma technology.

FDA is working with manufacturers to encourage industry innovation.

Archana M. Akalkotkar, PhD, research scientist I at Charles River, discusses the use of process validation to ensure quality.