The present invention relates to a bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing. Further, the use of a bioreactor for RNA in vitro transcription as described herein is part of the present invention. The present invention relates to an RNA in vitro transcription reactor designed to be operable in an automated manner under GMP-compliant conditions. In particular, said RNA in vitro transcription reactor allows repetitive use of DNA template for various RNA in vitro transcription reactions. Further, the invention relates to an apparatus for RNA manufacturing comprising (a) a module for template DNA synthesis, (b) a module for transcribing DNA into RNA comprising said RNA in vitro transcription reactor, and, optionally, (c) a module for RNA formulation.
An advantage of an improved bioreactor may be that it may allow for repetitive use of DNA templates in several RNA production processes which reduces the costs as less starting material (that is DNA template) has to be used and DNAse treatment can be omitted or substantially minimized. Moreover, an improved bioreactor may allow for the robust production of RNA with a higher purity profile (no residual DNAse, no residual DNA fragments in final RNA product). Advantages of an automated apparatus for RNA production are that the whole manufacturing process may be more robust and reliable (due to minimizing human error) and that the production of RNA may be accelerated.Further, an acceleration of RNA manufacturing would be highly advantageous and of major importance for public health, especially in the context of pandemic scenarios. Further advantageous in that context would be the production of the RNA therapeutics in the region of the outbreak which would, however, require a portable RNA production apparatus.
General Trend:
- Travel-sensitive and financial firms outperform after the Pfizer/BioNTech vaccine news; tech sector lags
- Consumer Discretionary firms drop in Shanghai, Oct CPI had slowest y/y rise since late 2009
- James Hardie declines by over 5% in Australia amid results/guidance
- Japanese officials declined to comment on size of 3rd extra budget
- RBNZ is due to issue monetary policy statement on Wed (Nov 11th); the central bank is expected to give an update on the development of its policy tools [including Funding for Lending Program]
***Headlines/Economic Data***
Australia/New Zealand
-ASX 200 opened %
- (AU) Australia PM Morrison: Confidence in Domestic economy return; Extends jobkeeper supplement by 3-months
- (AU) Australia ANZ Roy Morgan Weekly Consumer Confidence Index: 103.1 v 99.9 prior (10th consecutive increase)
- (NZ) New Zealand Government 3-Month Financial Statements: Rev NZ$23.7B v NZ$21.6B forecast; Deficit NZ$3.17B v NZ6.5B forecast
- (CN) According to analysts China is waiting for Australia to make the first move to repair relations between the countries, however anti-China sentiment is high in Australia putting the Govt in a difficult position - SCMP
Japan
-Nikkei 225 opened +1.0%
- (JP) Japan PM Suga orders extra budget - Japan press
- (JP) Japan Sept Current Account: ¥1.66T v ¥2.025Te; Adj Current Account: ¥1.35T v ¥1.794Te
- (JP) Japan Econ Min Nishimura: Confirms PM Suga has instructed completion of fresh economic package, nothing has been decided on size yet
- (JP) Japan Fin Min Aso: Japan economic decline was smaller, so rebound will be smaller; many industries are seeing demand recover, including autos
- (JP) Japan MoF sells ¥898.7B v ¥900B indicated in 0.6% 30-year JGBs, avg yield 0.6430% v 0.6380% prior, bid to cover 3.76x v 3.51x prior
-(JP) Japan Oct Eco Watchers Current Survey: 54.5 v 50.5e (Highest level since Jan 2014); Outlook Survey: 49.1 v 49.8e
Korea
-Kospi opened +0.3%
- (KR) South Korea GDP expected to be +3% in 2021 v contraction in 2020 - Korean press
- (KR) South Korea COVID cases in triple digits for 3rd consecutive day, authorities considering implementing stronger social distancing rules
China/Hong Kong
-Hang Seng opened +1.8%; Shanghai Composite opened +0.4%
- (CN) CHINA OCT CPI M/M: -0.3% V +0.2% PRIOR; Y/Y: 0.5% V 0.8%E (slowest y/y pace since Oct 2009); PPI Y/Y: 0.0% v -2.0%e; Pork prices -2.8% y/y (1st decline in 20-months)
- (CN) China PBOC sets Yuan reference rate: 6.5897 v 6.6123 prior
- (HK) Hong Kong Chief Exec Lam: No room to further relax social distancing rules, to extend social distancing rules for 1 week
- 2196.HK Trades limit up after the Pfizer/BionTech vaccine news
North America
- (US) Fed's Kaplan (FOMC dissenter): US economy is in the midst of a rebound out of deep contraction; risk is that a resurgence of COVID could overhelm hospitals and lead to lockdowns
- (US) Fed biannual Financial Stability Report: In the near term, risks associated with the course of COVID-19 and its effects on the U.S. and global economies remain high
- (US) Fed's Quarles (hawk, voter): Fed remains committed to using full range of tools to support economy as long as needed - prepared Congressional testimony
- LLY US FDA authorizes emergency use authorization for Bamlanivimab, an monoclonal antibody drug for COVID
- HDS Lowes comments on rumors: not in talks with Company and has no plans for a transaction with the company
- (US) Joe Biden Transition Team Spokesman: Legal action is a possibility if the GSA does not recognize Biden win in the US Election
Europe
- (UK) House of Lords votes against UK govt on proposed law that would grant ministers the power to override the EU exit treaty - press
***Levels as of 12:15ET***
- Hang Seng +0.8%; Shanghai Composite -0.1%; Kospi 0.0%; Nikkei225 +0.5%; ASX 200 +0.7%
- Equity Futures: S&P500 -0.6%; Nasdaq100 -0.6%, Dax -0.5%; FTSE100 -1.1%
- EUR 1.1840-1.1806; JPY 105.38-104.82; AUD 0.7289-0.7267; NZD 0.6841-0.6809
- Commodity Futures: Gold +1.4% at $1,879/oz; Crude Oil -1.3% at $39.77/brl; Copper +0.1% at $3.14/lb
After Hours Summary: BYND -22.1%, NBIX -13.4%, RAMP -11.4% down on earnings; XPER +25.7% jumps as it settles litigation with Comcast; ARNA -18% falls on clinical dataAfter Hours Gainers:
Companies trading higher in after hours in reaction to earnings/guidance: XPER +25.7% (also announces license agreement with Comcast which ends all litigation between the cos), FLGT +15.3%, SCOR +8.9%, ZI +7%, WES +6.7%, SPT +5%, RNG +4.9% (also also announces expanded partnership with BT), ZIXI +3.7% (also acquires privately-held CloudAlly), TLRY +3.5%, NGL +3.3%, STAY +2.9%, APPF +2.8%, NKLA +2%, INO +1.2%, HAIN +0.9%, DHT +0.8%, OSH +0.7%, SWAV +0.6%, WPM +0.2% (also increases dividend), MWA +0.1%, TCO +0.1%
Companies trading higher in after hours in reaction to news: HDS +15.4% (hearing LOW may be in talks to acquire HDS), AFMD +8.6% (announces licensing and strategic collaboration agreement with Roivant Sciences), SFT +5.8% (launches car marketplace in Texas), VNOM +5.7% (announces $100 mln share buyback plan), NLS +4.3% (files for $100 mln mixed securities shelf offering), LOW +4.1% (hearing LOW may be in talks to acquire HDS), ADBE +1.8% (confirms acquisition of Workfront for $1.5 bln), ACTG +1.7% (stock offerings), NVDA +1.6% (NVIDIA DRIVE to come included in entire lineup of Hyundai, Kia, and Genesis models starting in 2022), BA +1.6% (awarded $660 mln Air Force contract), SSTI +1.2% (to acquire Leeds), LMT +1% (awarded $260 mln Air Force contract; also LUV in talks to acquire as many as 30 737 Max jets that have lost their original buyers, according to Bloomberg), MRK +0.9% (to discontinue KEYNOTE-598 study of KEYTRUDA for futility on recommendation of independent Data Monitoring Committee; also initiates VERSATILE-002 Phase 2 trial), MU +0.4% (begins volume shipments of 176-layer 3D NAND flash memory), ESI +0.1% (initiates dividend), AUPH +0.1% (presents data from integrated analysis of AURA-LV and AURORA pivotal trials)
After Hours Losers:
Companies trading lower in after hours in reaction to earnings/guidance: BYND -22.1% (saw deterioration of its foodservice business as COVID-19 stay-at-home measures set in), ARNA -18%, NBIX -13.4%, RAMP -11.4%, SPG -8%, REAL -6.5%, IFF -4.8%, NVAX -4.8% (also names new CFO), ZGNX -4.8%, GSKY -2.3%, RPAY -2.2%, OXY -2%, AMBC -1.7%, IHRT -1%, ELY -0.9%, OR -0.5%, MBI -0.3%, AL -0.2%, NCLH -0.2%
Companies trading lower in after hours in reaction to news: ARNA -18% (announces primary endpoint not met in top line results from Phase 2b ADVISE trial; also reports earnings), TXMD -13.2% (stock offering), RVNC -7.6% (says Phase 2 trial for plantar fasciitis; primary efficacy endpoint not met), FSR -4.5% (stock offerings), AVEO -2.8% (files for $300 mln mixed securities shelf offering), FBIO -1.3% (stock offering), SIEN -1.1% (names new CEO, also reports earnings), FITB -0.6% (names new CFO), CDAY -0.1% (CNNE announces sale of 2,139,227 shares of CDAY), INSP -0.1% (announces full integration of Inspire Therapy into German DRG reimbursement system), GVA -0.1% (provides business update), FCPT -0.1% (increases dividend)


