Quality/GMPs

All CGMP requirements, including supporting activities, are critical in aseptic sterile manufacturing to ensure product quality and patient safety, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

As biopharma anticipates the “Facility of the Future,” a definition of what closed processing is, and quantification of its value, can be helpful information.

The agency will review the company’s supplemental new drug application for vutrisiran, a treatment for ATTR amyloidosis with cardiomyopathy.

Operating in an aging facility and/or utilizing outdated equipment may lead to drug shortages and high operating costs.

With FDA's clearance, Kedrion can manufacture Ryplazim (plasminogen, human-tvmh), the first and only FDA-approved therapy for treating PLGD-1, at its Bolognana, Italy, site.

With this $3.6 million investment, the CDMO will strengthen its advanced labeling, automated visual inspection, and fill/finish technology.

The approval of eladocagene exuparvovec-tneq (Kebilidi) marks the first FDA approval for a gene therapy to treat AADC deficiency.

Eisai Europe and Biogen have received a positive opinion for the monoclonal antibody therapy to be used as a treatment of adult patients with early Alzheimer’s disease.

Chancellor of the Exchequer, Rachel Reeves, has announced a £520 million (US$675 million) investment for manufacturing capacity in the United Kingdom, prompting academic and industry leaders to point out that funds should be used to train personnel.

Pfizer’s bivalent RSV prefusion F vaccine has been approved by FDA to prevent lower respiratory tract disease resulting from the respiratory syncytial virus in adults 18 to 59 years of age who are at increased risk.

The agency’s CHMP recommended drugs to treatments for hemophilia, two biosimilars for psoriasis, and two flu vaccines at their October meeting.

The draft joint network strategy for the EU until 2028 will be open for public consultation until Nov. 30, 2024.

Aseptic fill/finish of biopharmaceuticals requires an understanding of the structure and limitations of each molecule.

In this article, the authors explored the elimination of a water rinse and blow down following the caustic wash step, examining potential safety considerations, the effect on the quality of the cleaning process, and the potential benefit of implementing this change.

This year's CPHI award winners emphasize achievements in pharma excellence.

The agency is working with the European medicines regulatory network to improve the assessment and approval process for new medications.

Contract organizations offer assistance for testing raw materials obtained from outside suppliers.

There is potential to effectively marry the best aspects of mRNA as a modality, to other existing or nascent exciting platforms, such as gene editing.

Substituting a compendial-grade material with a food-grade material is not acceptable, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

FDA’s Darby Kozak provided commentary on the anniversary of the Drug Price Competition and Patent Term Restoration Act of 1984.

Approvals were recommended for treatments of ovarian cancer, lung cancer, bleeding disorders, respiratory disease, and more.

The agency is recommending the extension of the smallpox and mpox vaccine, Imvanex, to adolescents aged 12 to 17.

By approving EBGLYSS (lebrikizumab-lbkz), FDA has made available a new biologic treatment for moderate-to-severe atopic dermatitis that is not well controlled with topical treatments.

The company said this new commitment to its facility in Germany goes hand in hand with its recently announced ReciPredict, an initiative intended to streamline the product development cycle.

During a presentation at the PDA/FDA Joint Regulatory Conference, Nicholas Violand of Johnson & Johnson and Paul Palmer of Paul R. Palmer Limited discussed how aging facilities can impact the quality of pharmaceutical products.

CDER’s Jonathan Chapman, senior policy advisor, and Takeda’s Paulien Groll, head of Compliance Excellence, discussed how companies can be proactive with their CAPA strategies instead of reactive, at the 2024 PDA/FDA Joint Regulatory Conference.

Collaboration between technology providers and biopharma manufacturers are enabling both evolutionary and novel developments.

Viral vectors and other complex biologic modalities require more specificity and higher sensitivity to detect and distinguish contaminants.

As the field of bioanalytical testing evolves, it is important for drug developers to stay at the forefront of the advancements to ensure they remain competitive.

Updating your audits and inspections program ensures inspection preparedness, says Siegfried Schmitt, vice president, Technical at Parexel.