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US FDA accepts BASF Pharma Solutions’ excipient

Excipients (inactive ingredients) such as the Soluplus branded excipient play a critical role in enabling the drug development process for poorly s...

Wheeler Bio granted licence to ATUM’s tech

The tech provides Wheeler Bio’s clients with access to highly productive stable pools and clones with a significant regulatory track record

Sartorius and Exopharm sign joint research agreement

Partnership will address technical challenges of large-scale, high-efficiency purification of therapeutic exosomes for non-viral drug delivery

EU GMP Annex 1 (August 2022): impact on cleaning and disinfection

Cleaning and microbial contamination control are critical focus areas in the pharmaceutical and medical device industries. Robust cleaning and disi...

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Almac receives product approval by MHRA and Health Canada

The company’s site provides a range of solutions for blister packs, stickpacks, and kitting

Why create a participation-based chemical safety culture?

With 1.7 million workers suffering from work-related ill health in 2020/21, a recent Health and Safety Executive (HSE) report showed that health is...

Deciding on a chemistry, manufacturing and control strategy for biologic development

Khanh Ngo Courtney from Avomeen discusses what biopharmaceutical companies should keep in mind as they embark on their CMC journey

GHO Capital and The Vistria Group to acquire Alcami

Morgan Stanley & Co. LLC is serving as financial advisor and Kirkland & Ellis LLP is serving as legal advisor to Alcami

Polyplus and ENcell sign MoU for gene therapy discovery

ENCell started as a spin-off company of Samsung Medical Center in 2018 and is currently leading cell and gene therapy CMO market in Korea

EU supply chain regulation: what will it mean for companies attending CPHI?

Ahead of her session on “Manufacturing Excellence” at CPHI Frankfurt (1–3 November), Elisabeth Stampa, President of Medicines for Europe, along wit...

The new regulatory world for medical devices

Establishing an effective compliance strategy now ahead of the 2022 IVDR legislation is critical — because there’s more to come

OBX achieves ISO 9001:2015 certification

The company’s products and processes were put through a thorough evaluation process to achieve the certification

Partnering for successful commercial biologic manufacturing

There are a number of challenges and potential pitfalls when manufacturing a biologic drug in preparation for commercial launch and there are four...

EnteroBiotix receives MHRA MIA licensure for microbiome therapeutics

The company's facilities are headquartered in Scotland’s Strathclyde Business Park

Automation’s role in supporting regulatory operations

Robotic process automation (RPA) offers a cost-effective solution to laborious and repetitive document and data processing