Quality/GMPs

In addition to having the optimal cell line and process, it is crucial to have the optimal cell culture medium and feed to maximize performance potential.

Vendor selection and materials testing are complex enough, but in today’s volatile environment, risk mapping and monitoring are also crucial.

Interactive Coding Equipment has produced a detailed guide to help pharmaceutical manufacturers make informed choices in the selection of suitable coding equipment for their applications.

TraceLink launched the EU-hosted early access program to reduce the time, cost, and risk of achieving regulatory compliance for global requirements.

BioPharm International spoke with Trevor Marshall, director of enterprise systems integration at Zenith Technologies about automating processes in upstream processing.

The Czech Republic drug manufacturer was cited for data integrity and quality issues.

FDA’s new Office of Tissues and Advanced Therapies will oversee a growing range of cellular and genetic products.

FDA leaders insist that the decision to approve Sarepta’s Exondys (eteplirsen) should not be considered a model for future development of orphan drugs.

The new guidelines will address bioanalytical method validation and biopharmaceutics classification system-based biowaivers.

The agency awarded 21 new clinical trial research grants to boost the development of treatments for rare diseases.

FDA is working with EMA to treat rare diseases and keep patients involved in healthcare.

BioPharm International spoke with Selexis CEO and Chairman Igor Fisch, PhD about the latest cell-line development advances.

Are investigations supporting or hindering performance excellence?

Designing systems using the principles of good documentation practice, including validated audit trails, is a key piece of a manufacturing data integrity program.

Experts discuss recent advances in cell viability testing methods in bioreactors.

Wallace Cameron International was cited for not registering its Wishaw, Scotland facility with FDA.

Laboratoire Sintyl S.A. received an FDA warning letter for CGMP quality violations.

HHS entered into a contract with BioProtection Systems Corp. for commercial manufacturing tests of an Ebola vaccine.

The agency’s Patient-Focused Drug Development program completed its commitment ahead of schedule.

A report from the European Union Intellectual Property Office shows that the EU loses approximately €10.2 billion a year due to counterfeit medicines.

Value assessment initiatives are expected to have a major impact on drug use and reimbursement.

FDA’s Center for Drug Evaluation and Research provides an update on its safety initiatives.

EDQM and the Japanese Pharmacopoeia will improve the sharing of information on therapeutic products that are common in both Europe and Japan.

he guidance addresses the good manufacturing practice for managing quality in APIs.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs.