Quality/GMPs

The shift toward personalized medicines poses new challenges in cleanroom protocols.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.

Speaking at INTERPHEX 2025, William Wainwright, business development manager at Iwata Label USA, discusses the practical benefits of functional labels in protecting parenteral drugs.

Officially launched at INTERPHEX 2025, the Omni ASCENT is a next-generation off-site manufactured vertical utility solution that offers optimized cleanroom flexibility and efficiency.

Martin A. Makary, confirmed by a bipartisan vote of the US Senate, has been sworn in as FDA’s new commissioner.

Marks called out an ‘assault’ on truth and science in his resignation letter, which has sent the bio/pharmaceutical industry reeling.

Sherwin-Williams will showcase its advanced coating systems, which are designed to ensure safety, sterility, and efficiency in pharmaceutical manufacturing environments.

In response to a presidential Executive Order, the Department of Health and Human Services is planning to reduce its workforce, including cutting FDA staff by 3500 full-time employees, and reorganize some key departments.

The commission’s approval makes durvalumab the first and only immunotherapy for LS-SCLC in the EU.

The Therapeutic Goods Administration (TGA) of Australia confirmed its initial decision to decline approval of the mAb for treating early Alzheimer’s disease.

The committee’s recommendation is based on results from a Phase III trial in which Imfinzi demonstrated a reduced risk of recurrence, progression, or death by 32% compared to neoadjuvant chemotherapy alone.

Takeda’s TAKHZYRO (lanadelumab) is now approved in Europe as a subcutaneous injection treatment for hereditary angioedema in patients 12 years old and above and in adults.

The inspection focused on fill/finish of ongoing commercial supplies of an adeno-associated virus viral vector biologics product for a major pharmaceutical client in the United States.

Being fully versed on the ins and outs of design quality can improve the project design phase life cycle.

EMA’s CHMP recommended conditional marketing authorization for linvoseltamab to treat adults with relapsed and refractory multiple myeloma.

FDA has accepted Sanofi’s sBLA for the mAb and granted it priority review status for the targeted treatment of bullous pemphigoid.

Compliance and competitiveness are key factors in aseptic processing, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.

Artificial intelligence, among other technological advances, is pushing innovation boundaries.

The approval provides greater access to insulin treatment options.

Sponsor companies and contract development and manufacturing companies must ensure that the suppliers they use are following sustainability guidelines to truly produce ‘green’ products.

Contractors are working with sponsor companies to establish and maintain sustainable manufacturing practices in pharma.

Avtozma references Roche’s tocilizumab offering and has also shown promise as a treatment for CAR-T cell-induced cytokine release syndrome as well as COVID-19.

Contract manufacturers have special expertise in the characterization and validation of biopharmaceutical manufacturing processes.

The European Commission has approved Biocon Biologics’ YESINTEK, a biosimilar referencing Janssen Biotech’s Stelara (ustekinumab).

Vimkunya was granted approval under priority review based on positive results from two Phase III trials.

Ospomyv, or Obodence in the EU, and Xbryk were approved for all indications referencing Prolia and Xgeva, respectively.

This expanded label allows IZERVAY (avacincaptad pegol intravitreal solution) to be used without a limitation on duration of dosing for treating geographic atrophy.

The vaccine combines the antigenic components of two previously well-established meningococcal vaccines made by GSK.

The approval of an ADCETRIS combination regimen is based on positive data from a Phase III trial where the combination regimen demonstrated a clinically meaningful reduction in the risk of death.

The company plans to assess alternate payloads for its gene therapy program, which will shift its timeline.