In this week’s news, US efforts to encourage local drug production accelerate, PIC/S quality systems guidelines go live and more…

US lawmakers move forward with legislation to support drug and vaccine production

US Politicians have moved forward with new healthcare legislation that, in addition to other measures, would encourage the local production of medicines advocates say.

Last week the House Energy and Commerce Committee advanced several bipartisan health-related bills to the House for consideration, including several advocating for continuous manufacturing, supporting vaccination and addressing the ongoing opioid crisis.

Committee chair Frank Pallone, Jr. (D-NJ) said, “Among the legislation passed today were bills that support development of advanced pharmaceutical manufacturing technologies, provide resources to combat the ongoing opioid and substance use epidemic, and work to address social determinants of health.”

In related news Janet Woodcock, acting commissioner of the US Food and Drug Administration (FDA), spoke about issues impacting the ongoing vaccination programme in the US.

PIC/S quality systems and Covid-19 inspection guidelines go live

New Pharmaceutical Inspection Co-operation Scheme (PIC/S) guidance documents on the effectiveness of quality systems (PQS) and COVID-19 risk assessment for on-site inspections came into force this week.

PIC/S said the documents – here and here –  provide “practical guidance” for good GMP inspectors for quality system effectiveness and change management.

The organisation said the idea is to enable “more timely management of risks to product quality and patient safety, as well as better quality and manufacturing performance, continual improvement and innovation.”

Also in the news

Reuters reported that South Africa’s Biovac Institute will help manufacture around 100 million doses a year of Pfizer and Biontech’s COVID-19 vaccine for the African Union.

The Pink Sheet looked at concerns about capacity limitations for the production of COVID-19 vaccines and therapeutics.

The Wall Street Journal examined deal making in pharma and found that mid-sized companies were the most active last year.

GSK is seeking a partner to transform land at its 92-acre site in Stevenage into a biotechnology cluster for life science companies.

Lachman Consultants looked at the latest stage of GDUFA III negotiations.

The Atlantic wrote about industry desire to make changes at the US FDA.

The US Department of Commerce has announced a $153 million programme to support biopharmaceutical manufacturing in the country.

Politico looked at faltering US efforts to support COVID-19 vaccination programmes overseas.

CDMO trends

Some developments of note in the contracting sector:

JOS Pharmaceuticals has hired Catalent to undertake a feasibility study for a licensed cannabidiol (CBD) anaesthetic using its proprietary orally disintegrating tablet (ODT) technology.

Thermo Fisher Scientific has opened a new cGMP plasmid DNA manufacturing facility in Carlsbad, California citing growing demand for plasmid DNA-based therapies and vital mRNA-based vaccines.

Albany Molecular Research (AMRI) has changed its name to Curia, in a movie it says “reinforces the company’s strategic positioning as an end-to-end global CDMO.”

Curia also announced plans to acquire LakePharma, a biologics drug discovery, clinical research, development and manufacturing organization with operations in California, Massachusetts, and Texas.

GentiBio and CDMO Forge Biologics have formed a development and manufacturing partnership today to advance the former’s immune tolerance platform.