The
new biotherapeutics section on the EDQM website summarises Ph. Eur. Commission
activities and achievements in this field. In addition to clarification of the
role of Ph. Eur. monographs in the biosimilars regulatory pathway, it describes
the recently concluded P4-BIO pilot phase and the ongoing pilot phase on monoclonal
antibodies (“MAB pilot phase”), explaining the strategy followed by the Ph.
Eur. when setting requirements for the quality of this important class of
biotherapeutics. It also describes various levels of flexibility integrated
into Ph. Eur. texts, including those introduced recently to address the
structural complexity, heterogeneity and compound diversity derived from different
manufacturing processes of complex biotherapeutics.
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Thursday, 20 September 2018
EDQM publishes a new section dedicated to biotherapeutics
Wednesday, 19 September 2018
How soil bacteria munch on plastics
Thin
mulch films made of polyethylene are used in agriculture in numerous countries,
where they cause extensive soil contamination. Researchers have now identified
an alternative: films made of the polymer PBAT biodegrade in soils.
Our
world is drowning in a flood of plastic. Eight million tons of plastic end up
in the oceans every year. Agricultural soils are also threatened by plastic
pollution. Farmers around the world apply enormous amounts of polyethylene (PE)
mulch films onto soils to combat weeds, increase soil temperature and keep the
soil moist, thereby increasing overall crop yields.
After
harvest, it often is impossible for farmers to re-collect the entire films,
particularly when films are only a few micrometers thin. Film debris then makes
its way into the soil and accumulates in the soil over time, because PE does
not biodegrade. Film residues in soils decrease soil fertility, interfere with
water transport and diminish crop growth.
In
their experiments, the researchers used PBAT material that was
custom-synthesised from monomers to contain a defined amount of the stable
carbon-13 isotope. This isotope label enabled the scientists to track the
polymer-derived carbon along different biodegradation pathways in soil.
Upon
biodegrading PBAT, the soil microorganisms liberated carbon-13 from the
polymer.
Using
isotope-sensitive analytical equipment, the researchers found that the
carbon-13 from PBAT was not only converted into carbon dioxide (CO2) as a
result of microbial respiration but also incorporated into the biomass of
microorganisms colonizing the polymer surface.
The
researchers are the first to successfully demonstrate -- with high scientific
rigor -- that a plastic material is effectively biodegraded in soils.
Because
not all materials that were labelled "biodegradable" in the past
really fulfilled the necessary criteria. "By definition biodegradation
demands that microbes metabolically use all carbon in the polymer chains for
energy production and biomass formation -- as we now demonstrated for
PBAT," says Hans-Peter Kohler, environmental microbiologist at Eawag.
The
definition highlights that biodegradable plastics fundamentally differ from
those that merely disintegrate into tiny plastic particles, for instance after
exposure of the plastic to sunlight, but that do not mineralise.
In
their experiment, the researchers placed 60 grams of soil into glass bottles
each with a volume of 0.1 litre and subsequently inserted the PBAT films on a
solid support into the soil.
After
six weeks of incubation, the scientists assessed the extent to which soil
microorganisms had colonised the PBAT surfaces. They further quantified the
amount of CO2 that was formed in the incubation bottles and how much of the
carbon-13 isotope the CO2 contained. Finally, to directly demonstrate the
incorporation of carbon from the polymer in the biomass of microorganisms on
the polymer surfaces, they collaborated with researchers from the University of
Vienna.
See:
Michael
Thomas Zumstein, Arno Schintlmeister, Taylor Frederick Nelson, Rebekka
Baumgartner, Dagmar Woebken, Michael Wagner, Hans-Peter E. Kohler, Kristopher
McNeill, Michael Sander. Biodegradation of synthetic polymers in soils:
Tracking carbon into CO2and microbial biomass. Science Advances, 2018; 4 (7):
eaas9024 DOI: 10.1126/sciadv.aas9024
Monday, 10 September 2018
New PIC/S Guidance Documents
The
following new PIC/S Guidance documents have been adopted:
PIC/S
Aide-Memoire on “CrossContamination in Shared Facilities” (PI 043- 1).
PIC/S
Guidelines on the formalised risk assessment for ascertaining the appropriate GMP
for excipients of medicinal products for human use (PI 045-1).
PIC/S
Guideline on setting health-based exposure limits for use in risk
identification in the manufacture of different medicinal products in shared
facilities (PI 046-1).
PIC/S
Guidelines on the principles of GDP for active substances for medicinal
products for human use (PI 047-1).
Also,
the following Chapters and Annex of the PIC/S GMP Guide have been revised:
- Chapter 3 on “Premises and Equipment”;
- Chapter 5 on “Production”;
- Chapter 8 on “Complaints and Product Recall”;
- Annex 17 on “Real Time Release Testing and Parametric Release”.
- The revised Chapters are based on the equivalent Chapters of the EU GMP Guide with some minor differences in terms of language.
Monday, 3 September 2018
GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry
The fifth edition of the book "GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry" is now available, at a special introductory price.
The book is written by James Vesper and Tim Sandle. As companies strive to harmonize global requirements for quality systems, the 5th edition of this text provides an overview of the 34 essential global cGMP requirements that are typically included in a modern pharmaceutical quality system, including data integrity and how they have evolved. Explore risk-related questions, delve into several expectations for each quality system element encompasses, and review real-world examples from cGMP regulations from the US FDA, Health Canada, the European Union, the World Health Organization, and the International Conference on Harmonization (ICH). See: https://store.pda.org/ProductCatalog/Product.aspx?ID=4511
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology
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