Manufacturing, Drug Products

Detection of nitrosamines in several commercial drugs has resulted in manufacturing batch recalls followed by a review of the APIs’ synthesis processes by MAHs.

The new method was developed to isolate tissue-specific EVs from the blood in addition to using a workflow to analyze their diverse multi-omics content.

The first CleanCap analog was launched in 2017, and since then, the capping technology has been incorporated in one of the first commercially approved COVID-19 vaccines.

According to a press release, SGS has doubled its capacity for nitrosamine testing for North American customers.

The guidance is intended to build on the existing International Council for Harmonisation (ICH) quality guidance.

Collaboration and new tools aid efforts to implement new processing technologies for small-molecule drug product manufacturing.

A new focus on speed to market creates challenges for facility design and construction.

Hovione will invest $170 million in new capacity and capabilities in Portugal, Ireland, and New Jersey

Lonza’s investment in its Stein and Basel facilities in Switzerland aims to expand its overall drug product development and manufacturing services.

The COVID-19 pandemic has further impacted ongoing drug shortage issues; essential action is needed to avoid repeating previous mistakes.

USAntibiotics will serve as the sole American-based provider of amoxicillin and amoxil clavulanate.

The Cleveland, Ohio facility will produce critical anti-infective drug products for US hospitals.

Syngene’s additions include a new microbial facility and an expanded mammalian facility.

Almac Sciences has signed a manufacturing agreement with Pila Pharma for the production of the API XEN-D0501.

Recro acquires CDMO IRISYS, establishing a bi-coastal presence in the US.

Veraxa and Indivumed will work together to develop colorectal antibody drugs.

Kyowa Pharmaceutical Industry and Bora Pharmaceuticals have announced a partnership to produce generic-drug product for filing in Japan.

Syngene International appoints two US-based executives to senior level positions.

VICO Therapeutics’ drug candidate, VO659, for treating Huntington’s Disease was granted orphan drug designation by FDA.

Expanded interest in advanced drug manufacturing and continuous production methods calls for more flexible production systems and regulatory policies.

Evonik has introduced the EUDRACAP, a portfolio of easy-to-handle capsules to fast-track speed to market for oral drug products in the early development stage.

BioNTech plans to expand its global footprint by establishing its regional headquarters for southeast Asia and a new mRNA manufacturing facility in Singapore.

The expanded agreement will include aseptic fill/finish services at its San Diego, CA facility.

EMA has approved the manufacturing of drug product for BioNTech’s COVID-19 vaccine, BNT162b2, at BioNTech’s manufacturing site located in Marburg, Germany.

The companies will aim to establish clinical and commercial supply agreements for Plus Therapeutics’ RNL-liposome drug product at the appropriate stage of development.

The acquisition will integrate drug substance, drug product, and clinical testing capabilities under Quotient.

Emergent will use its CDMO services to manufacture drug product batches to support the increased supply of the therapeutic candidate in anticipation of a potential emergency use authorization in the first quarter of 2021.

The expansion will include new suites for the development and clinical manufacturing of drug product intermediates and drug products and cGMP suites for early-phase cGMP manufacture.

Samsung will offer large-scale commercial manufacturing for drug substance and drug products to support AstraZeneca’s biologics therapeutics capabilities in the Asia-Pacific region.

The new line has the ability to aseptically fill powder, liquid, suspension, and combination forms into vials in clinical or commercial batch sizes.