Susan Haigney

The booming cell therapy market has created a need for capacity that outsourcing partners are ready to fill.

Performing corrective action and preventive action (CAPA) activities is often necessary to investigate a manufacturing deviation and prevent it from reoccurring. BioPharm International asked Joe O’Gorman, head of Global Operations at LZ Lifescience, a Cognizant Company, about the role technology plays in performing CAPAs.

Disruptions in the bio/pharmaceutical supply chain can have serious impacts on the quality and availability of life-saving medicines.

As regulators balance pandemic tasks and rethink procedures, quality at manufacturing facilities is still a priority.

COVID-19 created challenges for quality control departments. How have the lessons learned from the pandemic influenced the way companies use technology to perform quality-control procedures?

BioPharm International asked Vincent Colicchio, vice president, supply chain and external manufacturing at Dr. Reddy’s Laboratories, about how a lack of proper supplier oversight can impact the pharmaceutical industry and the drug supply chain.

CMOs and CDMOs adjust business processes as demand for COVID-19 treatments and non-pandemic related therapies puts pressure on the bio/pharma industry.

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.