|Biobased and Renewable Products Update|
|February 27, 2020|
FDA Issues Final Rule Amending The Definition Of “Biological Product”
On February 21, 2020, the U.S. Food and Drug Administration (FDA) issued a final rule to amend its regulation that defines “biological product.” The new definition incorporates changes made by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) and the Further Consolidated Appropriations Act, 2020 (FCA Act). Under the final rule, the statutory term “protein” is interpreted to mean any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. Intended to clarify the statutory framework under which such products are regulated, the final rule will be effective on March 23, 2020.
FDA Upgrades Its Database Of Licensed Biological Products
On February 24, 2020, FDA Commissioner Stephen M. Hahn, M.D., announced that FDA is upgrading its Purple Book, which is otherwise known as its “Database of FDA-Licensed Biological Products.” According to Dr. Hahn, FDA is working to expand the Purple Book by transitioning from its current list format to a searchable online database for all approved biosimilar products and their reference products. An upgrade planned to be released in multiple phases, the full search functionality is the first step. Subsequent phases will include the expansion of the number of FDA-licensed biological products included in the Purple Book online database until the final release, which will include information about all FDA-licensed biological products. The aim is to grow the data set to include data and information about all Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) regulated products.
The first phase of the upgrade includes information about a product’s proprietary and proper names, the full product label, dosage form, route of administration, strength, and marketing status, among other information. FDA plans to open a public docket to gather feedback from stakeholders on the new database with its enhanced functionality. In the announcement, Dr. Hahn stated that “[t]his expansion and digitization of the Purple Book will make more information about FDA-licensed biological products more accessible, increasing transparency for patients, industry users and other stakeholders.”
DOE EERE To Host Public Workshops On ESGC Across The Country
On February 21, 2020, U.S. Department of Energy’s (DOE) Office of Energy Efficiency and Renewable Energy (EERE), announced that it will hold a series of workshops to receive input on the approaches and activities for its new initiative, the Energy Storage Grand Challenge (ESGC). Launched in January 2020 by DOE Secretary Dan Brouillette, ESGC was created to accelerate the development, commercialization, and utilization of next-generation energy storage technologies. With the aim to sustain American global leadership in energy storage, ESGC builds on the $158 million Advanced Energy Storage Initiative. Recognizing the challenges associated with the advancement of energy storage technologies, DOE EERE will host four workshops to receive input on ESGC initiative approaches and activities. The workshops’ dates, locations, and registration deadlines are:
- March 6, 2020, in Seattle, Washington – registration deadline: February 27, 2020;
- March 10, 2020, in Austin, Texas – registration deadline was February 24, 2020;
- March 17, 2020, in Chicago, Ilinois (additional manufacturing session will be held on March 16, 2020) – registration deadline: March 2, 2020; and
- March 26, 2020, in Washington, D.C. – registration deadline: March 11, 2020.
Parties interested in registering for one of the workshops may do so here. Seating is limited, and registrations will be accepted in the order they are received.
DOE ORNL Develops Method For Observing Biomaterials’ Nanostructure
On February 25, 2020, DOE’s Oak Ridge National Laboratory (ORNL) announced that its scientists have developed a novel technique to closely observe the nanostructure of biomaterials without damaging the sample. Using a nonintrusive soft mechanical nanoablation (sMNA) technique can confirm structural features in starch, which is an important carbohydrate in the production of biofuels. ORNL’s chief scientist for systems biology and biotechnology, Brian Davison, highlighted the importance of plant cell wall structures in the next generation of biofuels, stating that the “study used starch as an example of how this technique can start to access some of these nanomechanical structure materials” that currently cannot be observed. ORNL’s study was published on February 6, 2020. ORNL scientists believe the novel technique can also be applied to nonliving materials and used on synthetic polymers or even three-dimensional-printed materials.
ASTM International Biotechnology Task Group Seeking Members
The international standards organization, ASTM International, is seeking additional task group members to further develop the current terminology standard in industrial biotechnology (E3072-19). ASTM International develops and publishes voluntary consensus technical standards for a wide range of materials, products, systems, and services. Its sub-committee, E62.91 for Terminology in Industrial Biotechnology, is responsible for suggesting new terms and definitions to be added to the current standard and for revising existing terms and definitions as needed. The meanings and explanations of the technical terms have been written for both non-expert and expert users and is updated annually to include editorially any terms approved in the committees of technical standards. This standard, however, does not purport to address all of the safety concerns, if any, associated with the use of biotechnology products, materials, systems, or services. Interested parties should contact the sub-committee chair, Joseph McAuliffe, or the E62 staff manager, Pat Picariello, directly.
Finnish Scientists Develop Bioplastic With Capacity To Block UV Radiation
On February 19, 2020, the University of Oulu, Finland, announced that scientists from its Research Unit of Sustainable Chemistry have developed a new synthetic bioplastic that provides protection from ultraviolet (UV) radiation. In addition to its UV-light blocking capacity, the transparent bioplastic made from a biomass-based copolymer with bisfuran structure, the new bioplastic also has airtightness capabilities three to four times higher than polyethylene terephthalate (PET) plastic. The raw materials used in the production of this entirely biomass-based plastic are hydroxymethylfurfural (HMF) and furfural, which are biorefinery products derived from cellulose and hemicellulose. University of Oulu researchers chemically linked the two chemicals to create copolymer parts with bisfuran and furan-like structures. The research results have been published, and a patent application for the bioplastic has been filed for the new method developed.
ZME Science, “Towards the Regulation of Bio-Based Materials in
European Plastic Product Manufacturer, “New Project Creates Bio-Based Boards for a Thermal
Insulation Composite System”|
EurekAlert!, “Scientists Develop Open-Source Software to Analyze
Economics of Biofuels, Bioproducts”|
c&en, “Investors Chase Sustainable Aromatics”|
ScienceDaily, “From Petroleum to Wood in the Chemical Industry:
Cost-Efficient and More Sustainable”|
|■|| Phys.org, “Stabilizing Freeze-Dried Cellular Machinery Unlocks Cell-Free Biotechnology”|
Biobased and Renewable
Products Advocacy Group
2200 Pennsylvania Ave., N.W.
Washington, D.C. 20037