Manufacturing

Single-use systems demonstrate advantages over stainless-steel systems for biopharmaceutical manufacturing facilities.

BioVectra will open its new microbial fermentation and complex chemistry site, including the capability to handle high-potency APIs, by the end of 2017.

The pharmaceutical industry is making efforts by internally assessing, developing, and implementing semi-continuous manufacturing processes to improve manufacturing efficiencies.

The company will expand its production facilities in Carlow and Cork to meet increased global demand for its medicines and vaccines produced in Ireland.

The new storage and distribution facility provides PCI with additional space, complementing its existing footprint currently used for specialist clinical-trial logistics as well as packaging, labeling, and qualified person activities for investigational medicinal products.

A recent survey suggests that 36% of pharmaceutical companies and contract development and manufacturing companies have not started working on serialization, and that those who are working on it are focusing on basic compliance rather than potential long-term business benefits.

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.