Susan Haigney

The COVID-19 pandemic has triggered additional considerations to supplier oversight of contract manufacturing facilities.

The agency’s focus appears to be on generic drugs for the upcoming year.

Outsourcing increases as the industry balances development and manufacturing of both COVID-19 treatments and non-pandemic-related medicines.

The European Pharmacopoeia is preparing for 2021 while also supporting the industry to develop vaccines and treatments for COVID-19.

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

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.

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

BioPharm International spoke with Marybeth Reynoso, senior director, early development strategic operations at PPD about the direction the industry is taking regarding the outsourcing of early development operations to contract research organizations (CROs).

Industry experts discuss the challenges and regulations of setting up a CGMP-compliant stability testing program.

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

Despite the growing popularity of single-use technologies in biomanufacturing, there are still instances where stainless steel is the better option.

Using a QbD approach from early-stage development through commercialization can ensure that upstream processes are efficient and reliable.

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

Quality by design brings both challenges and benefits to the development of downstream processes.

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

Industry is searching for ways to deal with the criticality of ensuring data integrity.

Experts discuss best practices for performing glycan analysis.

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

Trace elements in raw materials may impact the quality and safety of the finished biologic product, according to industry experts.

Quality experts share insights on what the future may hold regarding regulatory quality requirements for biopharmaceuticals.

BioPharm International asked an FDA spokesperson how the agency plans on handling these issues in the future.

An understanding of the unique nature of single-use systems, and how they interact with each biomanufacturing process, is important when qualifying single-use systems.

Industry experts discuss how to address extractables and leachables in single-use systems and the challenges in qualifying equipment.

Outsourcing analytics can be a cost-effective way for biopharma companies to adapt to new technologies and regulations.

Contract testing organizations can provide bio/pharma companies with a cost-effective way to adapt to new technologies and regulations.

Process validation is an extension of biologics development processes.

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

At CPhI North America 2017, the US Pharmacopeial Convention will be discussing its upcoming revision and modernization of the standards for elemental and organic impurities.

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