In this week’s news, US FDA updates on combo-drug inspections, EMA outlines Covid-19 continuity plan, DCAT tracks interest in HPAPIs and more…

US FDA details compliance programme for combo-drug inspections

The US FDA has shared details of its compliance program for CDER, CDRH-led combination product inspections.

The document covers how the agency intends to implement the programme, with details of inspections and reporting considerations as well as how it CDER and CDRH will approach sampling and analytical testing.

The FDA wrote, “The objective of this compliance program is to provide a framework for conducting inspections of single-entity and co-packaged combination product manufacturing facilities.

“This compliance program relies on relevant inspectional processes for CGMPs from the compliance programs specific to drugs, devices, and biological products, and addresses combination product-specific considerations.”

The programme does not apply to inspections for Center for Biologics Evaluation and Research-led combination products according to the FDA, which said it “should not be used for inspections of facilities that only manufacture one type of constituent part or product components.”

EMA pledges to keep regulating during pandemic

The EMA has set out how it plans to continue its regulatory activities during the Covid-19 pandemic.

The Amsterdam-based agency set out its plan last week. It said the aim is to make clear how “core regulatory activities, such as the authorisation, maintenance and supervision of human and veterinary medicines will continue to be carried out.”

It wrote, “Under no circumstances can the assessment of medicines used to treat or prevent COVID-19 be delayed, and Member States must consider their resources and capacity, when putting themselves forward to deal with such an assessment on behalf of the EU.”

Specific measures include how Member States will provide back-up for each other, if the disruptions caused by COVID-19 affects their ability to carry out assigned assessments.

See the European Medicines Regulatory Network COVID-19 Business Continuity Plan here.

USP working recombinant Factor C (rFC) chapter for endotoxin testing

The USP wants to add extra bacterial endotoxin detection methods in a move to support developers working on vaccines and other injectable therapeutics.

The organisation published details in a compendial notice and prospectus last month.

It said, “USP intends to develop a new informational chapter that contains recommendations for the use and qualification of recombinant reagents as alternatives to naturally sourced reagents from horseshoe crabs Limulus polyphemus or Tachypleus tridentatus hemolymph for the purposes of measuring endotoxins activity in injectable drugs, biologics and medical devices where applicable.”

As Contract Pharma pointed out the “primary benefit of the rFC reagent is improved consistency and sustainability. Variation is a common feature among all animal-sourced products.

“The consistency of a synthetic can make manufacturing and testing processes easier to control and because rFC can be made in unlimited quantities, it is more sustainable.”

CDMOs adding HPAPI capacity

CDMO sector investment in HPAPI manufacturing capacity continues to increase according to analysis by DCAT.

The industry organisation looked at HPAPIs in an article last week, concluding that “driven by growth in oncology drugs, high-potency manufacturing is an active area of investment by CDMOs/CMOs.”

The article cites Lonza, Wuxi AppTec, Segens, Cambrex and Piramal among the most active in the sector. It suggests pharma industry interest hybrid therapeutics, such as antibody-drug conjugates (ADCs) are a growing part of the market and an opportunity for CDMOs/CMOs.

See more here.

Also in the news

Inside Health Policy reports the US GAO has criticised the FDA for how it is conducting inspections of overseas manufacturing facilities during the Covid-19 pandemic.

Fiercepharma says the EU is looking at a “BARDA-style” organisation that will contract the development of SARS-CoV-2 vaccines.

STAT reports that US pharmaceutical companies are concerned about calls for more medicines to be made in the country.

The publication also covered Inovio’s decision to sue its contract manufacturer VGXI.

CDMO tends

Some development of note in the contracting space:

PCI Pharma Services has teamed with Experic. The deal provides Experic with access to PCI’s clinical and commercial supply chain capabilities in return for use of its powder-filling equipment. See press release.

Ajinomoto has bought Granules OmniChem Private, buying the remaining 50 percent ownership interest from its joint venture partner, Granules India Limited. See statement.

BARDA has tasked Emergent Biosolutions to support US Government efforts to accelerate delivery of COVID-19 vaccines. See announcement.

Tonix Pharmaceuticals has hired Fujifilm Diosynth Biotechnologies (FDB) to support the manufacturing of its COVID-19 vaccine candidate, TNX-1800, for clinical trials.

Berkshire Sterile Manufacturing has secured $16.5 million in financing to add manufacturing capabilities including an additional robotic line for producing sterile drug products in vials, syringes, and cartridges. See press release.

Novavax has hired AGC Biologics to make the adjuvant for its candidate SARS-CoV-2 vaccine. See announcement.

Lonza has appointed Pierre-Alain Ruffieux as CEO. He will take over in November according to Contract Pharma.