Manufacturing

Due to weak penalties and lax enforcement, illicit pharmaceuticals continue to slip into the US, European and global supply chains.

Saneca has been granted approval to manufacture and supply multiple dosage forms to Russia.  

Catalent has signed an agreement with Therachon to support preclinical and clinical development of TA-46, a novel protein being developed to treat achondroplasia.

Catalent has been working together with Lexicon to develop the drug formulation of Xermelo, which has now been approved by FDA for the treatment of carcinoid syndrome diarrhea.

Understanding the purpose of the biological indicator can guide the development of an effective sterilization process.

A multi-pronged approach to raw materials testing can help mitigate the risk of future contamination events.

Good project management, budgeting, planning, and clear documentation are the only ways to prevent overruns and project failure.

The existing, obsolete highpurity water generation system and water-forinjection generation system were replaced with new, reliable technologies.

The decision to use disposable bioreactors is now driven by commercial rather than technological considerations.

Samsung BioLogics’ aggressive growth strategy begs the question: Are there lessons that US and European pharma might still learn from the electronics industry?

Manufacturing for originator molecules is restricted by regulations, but drug makers can exploit newer technologies for the manufacture of biosimilars.

The company invested approximately $26 million to update its sterile pharmaceutical and development service suites.

Bosch’s Xelum platform is designed for continuous production of oral solid-dosage forms.

The company is expanding their April 2017 voluntary recall of phenobarbital tablets.

FDA sent a warning letter to Pharmaceutic Labs, LLC for deficiencies in producing sterile drugs.

EMA and the European Commission released a biosimilars information guide for health professionals during the EC’s biosimilars conference.

Learn how to prevent common causes of product loss.

Robotic fill/finish systems reduce human intervention, improve flexibility, and allow more gentle handling of containers.

Recent legislation and PDUFA initiatives aim to streamline oversight and testing requirements.

Innovative new technologies released over the past several months seek to enhance bio/pharmaceutical development and manufacturing.

Advances in equipment, instrument, and control systems are enabling online monitoring of continuous API manufacturing.

Contract manufacturing organizations may fill manufacturing gaps created by a lack of trained workers at Chinese biopharma companies.

Value-based medicine is putting patients at the center of pharmaceutical R&D and forcing the industry to move from treatment to prevention.

The author discusses the impact of prefilled syringe product contact materials and the filling and stoppering process on protein aggregates.

Transdermal and inhaled/nasal delivery provide alternative routes of administration for macromolecules.

Solid-phase extraction has several advantages over liquid/liquid extraction for extractables and leachables studies.

Avid, a wholly owned subsidiary of Peregrine Pharmaceuticals, will upgrade its Myford, California clinical and commercial manufacturing facility with multiple Mobius 2000-L single-use bioreactors from MilliporeSigma, the companies announced on May 1, 2017.

The type of water for pharmaceutical use is determined by USP testing.

Innovative new technologies released over the past several months seek to enhance bio/pharmaceutical development and manufacturing.

Companies believe that biologics and biosimilars would experience the fastest growth over the next year; there is also interest on increasing market penetration of generic drugs.