In this week’s news, ICH beefs up the analytical methods guide, Dutch OK pictogram pack warnings, and more

ICH issues analytical methods guidelines

The International Council for Harmonization (ICH) on Thursday issued draft guidelines to help manufacturers switch analytical methods for testing medicines after approval.

The ICH announced the guidelines last week, explaining they provide a framework for the principles of analytical procedure validation applicable to products. 

It said they are intended to complement ICH Q8 to Q12 Guidelines, as well as on-going ICH Q13 for Continuous Manufacturing, with a “view to potentially combine both documents into one, for simplification and clarity.”

Dutch MEB oks pictogram warning on packaging

Dutch drug regulators have cleared manufacturers to use pictograms on packaging to indicate warnings about potential risks.
 
The pictograms cover risks related to pregnancy, breastfeeding, driving and the consumption of alcohol. There are two versions of each, a red version that indicates the patient should not take the product and a yellow version that advises the patient to consult a pharmacist.

Read full MEB Notice (Dutch)

Medical device group revises ethics code with an eye on CDMOs

Industry group MEDTech Europe has revised its ethical code to provide additional information on topics including collaborative research and third-party intermediaries.

The revision overhauls the code, which was adopted in 2015.  MedTech Europe CEO Serge Bernasconi said, “This revision, which also enhances usability and reader-friendliness, shows our industry’s continued commitment to ethics, integrity and transparency. 

“By clarifying existing provisions, adding new sections to address additional types of [healthcare professional] interactions, and further developing the Code’s underlying values, the updates further support industry’s strong compliance principles.”

 

Also in the news

Bioprocess Insider looked at ThermoGenesis’ decision to lease a facility in Sacramento, California to house its newly launched cell therapy contract manufacturing business, TG Biosynthesis. 

Sumitomo Chemical will construct a manufacturing plant for active pharmaceutical ingredients (APIs) and intermediates at its Oita Works according to Chemical Engineering.

Bayer plans to spend – or “dump” according to Endpoints – $2.26 billion to realign its manufacturing operations. The project will see it set up new facilities in the US and Europe.

RAPS covered US FDA plans to enhance cybersecurity for medical devices and to address a legal loophole impacting generic drugs.

SCRIP reported comments by Deloitte economist Ira Kalish that Vladimir Putin’s war in Ukraine has increased macroeconomic uncertainty, which is keeping businesses and drug industry investors from deploying capital.

Abzena secures $65m in funding round. In addition to building out existing and additional manufacturing facilities, the funding will be used to augment drug discovery and cell line offerings.

Packaging Europe published an article on packaging self-administered injectables and infusibles for better patient outcomes.

 

CDMO trends

Some developments of note in the contracting sector: 

Rentschler Biopharma and Vetter have shared details of their strategic collaboration describing the move as “an important step in heightening the visibility of the collaborative services to clients.”

Avondale Pharmaceuticals has formed a product development partnership with Cambrex under which the latter will provide drug substance, drug product, and analytical services.

Alcami plans to expand its biostorage footprint at Masy BioServices with a new 160,000 square-foot facility, purpose-built for cGMP pallet storage space at 15°C to 30°C.

Ten23 health will expand its facility in Visp, Switzerland. The firm will add space for visual inspection, cold storage, cleanroom and other services.

Rokote Laboratories Finland has hired Exothera to make its intranasal coronavirus vaccine FINCoVac 2.0 for Phase I/II trials. Exothera will fine tune the production process and manufacture clinical material.