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• Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Drug Development | Industry News
  

  Gamma Biosciences Acquires Stake in Mirus Bio

  Supports Mirus’ expansion of GMP production of its flagship product TransIT VirusGEN for large scale manufacturing of AAV and LV viral vectors for gene therapy.

  Kristin Brooks 05.18.21
  

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• Bio News | Bioanalytical Services | Biologics, Proteins, Vaccines | Breaking News | Industry News
  

  PerkinElmer Acquires Nexcelom Bioscience

  Bolsters preclinical portfolio and enhances QA/QC capabilities in cell and gene therapy and biologics manufacturing.

  Tim Wright, Editor, Contract Pharma 05.17.21
  

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• Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News | Parenterals
  

  Humanigen Selects Chime Biologics as Manufacturing Partner

  Ink manufacturing deal for COVID-19 therapeutic candidate lenzilumab.

  Tim Wright, Editor, Contract Pharma 05.17.21
  

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• Biologics, Proteins, Vaccines | Breaking News | CRO News | Industry News
  

  Charles River to Acquire Vigene Biosciences

  Expands Charles River’s scientific capabilities in the high-growth cell and gene therapy CDMO sector.

  Charles Sternberg, Assistant Editor 05.17.21
  

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• Biologics, Proteins, Vaccines | Breaking News | Industry News
  

  Avantor Boosts Global Production of Single ­Use Technologies

  To increase single-use manufacturing footprint by 30% and double its cleanroom space in the U.S. and Europe.

  Kristin Brooks 05.14.21
  

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• Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News
  

  WuXi Biologics, WuXi STA Establish WuXi XDC JV

  To provide contract development and manufacturing of bioconjugates including antibody-drug conjugates (ADCs).

  Kristin Brooks 05.14.21
  

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• Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
  

  FDA Expands EUA for Pfizer, BioNTech’s Covid-19 Vax

  Expands the authorization to include individuals 12-15 years of age.

  Charles Sternberg, Assistant Editor 05.11.21
  

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• Biologics, Proteins, Vaccines | Clinical Trials | Trials & Filings
  

  INOVIO’s DNA COVID Vax Achieves Positive Results

  Phase 2 clinical trial shows INO-4800 was generally safe, well-tolerated and immunogenic in all studied age groups.

  Kristin Brooks 05.10.21
  

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• Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Drug Development
  

  IDRI, Duke Vax Institute, 3M Partner on Adjuvant COVID Vax

  Studies show 3M-052/Alum formulation elicits a strong, durable immune response against several strains of coronavirus, including bat coronaviruses.

  Kristin Brooks 05.10.21
  

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• Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News
  

  BioNTech to Establish Regional HQ and Mfg. Facility in Singapore

  New manufacturing site will support global supply of mRNA-based vaccines and therapeutics.

  Kristin Brooks 05.10.21
  

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• Breaking News | Facilities | Fill/Finish | Industry News | Parenterals | Vials
  

  Aenova Expands Capacity for Fill & Finish of Vaccines and Biologics

  New €16M area for sterile production including vaccine fill and finish is being built at the Aenova site in Latina, Italy.

  Tim Wright, Editor, Contract Pharma 05.07.21
  

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• Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News
  

  Catalent Acquires Commercial-Scale Plasmid DNA Mfg. Facility

  Promethera’s Hepatic Cell Therapy Support SA include's 32,400 sq.-ft. facility in Gosselies, Belgium.

  Kristin Brooks, Contract Pharma 05.06.21
  

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• Biologics, Proteins, Vaccines | Breaking News | Industry News
  

  Novavax, Gavi Execute APA for COVID-19 Vax

  Novavax to deliver 350 million doses beginning 3Q21.

  Kristin Brooks, Contract Pharma 05.06.21
  

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• Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances
  

  ADC Therapeutics Receives FDA Approval for Zynlonta

  ADC collaborated with Sterling Pharma Solutions to develop Zynlonta.

  Charles Sternberg, Assistant Editor 05.06.21
  

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• Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News
  

  Richter-Helm Triples cGMP Production Capacity

  Will invest close to €70 million to triple current biologic production capacity and expand existing warehouse, lab, and administration buildings.

  Kristin Brooks 05.06.21
  

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• Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News
  

  Lonza Expanding Next-Gen Mammalian Mfg. Facilities

  Will invest approximately CHF 850 million to build two new state-of-the-art mammalian facilities in Visp and Portsmouth, U.S.

  Kristin Brooks 05.06.21
  

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• Biologics, Proteins, Vaccines
  

  Gene Therapy Manufacturing Trends

  Accelerating the path to industrialized gene therapy manufacturing with high capacity, scalable, fixed-bed bioreactors.

  Alex Chatel, Product Manager for Viral Applications, Univercells Technologies 05.05.21
  

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• Biologics, Proteins, Vaccines
  

  Overcoming AAV Manufacturing Challenges

  Disruptive technologies and advances in analytics are needed to enable wider application of gene therapies in a cost effective and sustainable way.

  Sybil Danby, Senior Vice President of Business Development and Strategy, Center for Breakthrough Medicines 05.05.21
  

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• Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News
  

  Clean Biologics Acquires Biodextris

  To establish North American presence and expand activities with Biodextris’ complementary services.

  Tim Wright, Editor, Contract Pharma 05.05.21
  

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• Biologics, Proteins, Vaccines | Breaking News | Industry News
  

  Moderna to Increase Global Supply for COVID-19 Vaccine

  Will supply up to 3 billion doses in 2022 and double supply from ex-U.S. supply chain.

  Tim Wright, Editor, Contract Pharma 05.03.21
  

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• Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Fill/Finish | Industry News
  

  Sanofi, Moderna Enter COVID-19 Vaccine Fill/Finish Manufacturing Deal

  Sanofi will provide fill/finish services for up to 200 million doses of Moderna’s COVID-19 vaccine in the U.S. beginning in September 2021.

  Tim Wright, Editor, Contract Pharma 05.03.21
  

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• Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News | R&D
  

  Albumedix Extends Research Collaboration with Cobra Biologics

  Collaboration investigates enhanced manufacturing of AAV and lentiviral vectors to improve quality and productivity for gene therapy and vaccine developers.

  Tim Wright, Editor, Contract Pharma 05.03.21
  

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• Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Drug Development | Industry News
  

  CCRM and Amgen Partner to Advance Emerging Medical Innovations

  New fund to support regenerative medicine discoveries with high potential impact for patients.

  Tim Wright, Editor, Contract Pharma 05.03.21
  

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• Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News
  

  GenScript Launches Research Lentiviral Vector Packaging Service

  Enables scientists to package their genetic material of choice to ensure consistent production of functional and intact viruses.

  Charles Sternberg, Assistant Editor 04.29.21
  

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• Bio News | Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Facilities | Industry News | Validation
  

  ADMA Receives FDA Approval for Increased IVIG Production Scale

  Increases plant manufacturing capacity from 400,000L to 600,000L.

  Tim Wright, Editor, Contract Pharma 04.29.21
  

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• Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Facilities | Industry News
  

  Lonza Doubles Drug Substance Production for Moderna’s COVID-19 Vaccine

  New agreement for three additional production lines at Lonza’s site in Visp, Switzerland.

  Tim Wright, Editor, Contract Pharma 04.29.21
  

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• Biologics, Proteins, Vaccines | Breaking News
  

  Introducing ViroCell Biologics

  The UK’s first clinical trial focused viral vector manufacturer.

  Charles Sternberg, Assistant Editor 04.28.21
  

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• Bio News | Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Collaborations & Alliances | Industry News
  

  Samsung Biologics, TG Therapeutics Expand Manufacturing Collaboration

  Expands existing contract manufacturing deal to further enable global manufacture of ublituximab.

  Tim Wright, Editor, Contract Pharma 04.27.21
  

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• Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News
  

  Bristol Myers Squibb Invests in Cell Therapy Ops

  New manufacturing site planned in the Netherlands is the company’s fifth facility dedicated to cell therapy.

  Tim Wright, Editor, Contract Pharma 04.27.21
  

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• Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
  

  RDIF, Minapharm to Make Over 40M Doses of the Sputnik V Vaccine in Egypt

  Production will take place in Minapharm’s biotech facility in Cairo for global distribution.

  Tim Wright, Editor, Contract Pharma 04.23.21
  

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• Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News
  

  Valneva Focuses on Bilateral Discussions to Supply COVID-19 Vax

  Looks to secure a supply agreement for the only inactivated vaccine candidate in clinical trials against COVID-19 in EU.

  Kristin Brooks 04.22.21
  

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• Biologics, Proteins, Vaccines | Clinical Trials | Trials & Filings
  

  Valneva’s Inactivated, Adjuvanted COVID-19 Vax Achieves Positive Data

  VLA2001 was highly immunogenic with more than 90% of study participants developing significant levels of antibodies to SARS-CoV-2 virus spike protein.

  Kristin Brooks 04.22.21
  

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• Bio News | Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture
  

  Evotec to Build Second Biologics Mfg. Facility in Toulouse

  Evotec's first commercial biomanufacturing facility in Europe is anticipated to deliver much needed capacity for biotherapeutic development and manufacturing.

  Kristin Brooks 04.20.21
  

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• Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News
  

  Resilience Acquires Ology Bioservices

  Continues expansion with acquisition of biologics manufacturing company.

  Tim Wright, Editor, Contract Pharma 04.19.21
  

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• Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
  

  RDIF, Hualan Ink COVID-19 Vaccine Deal

  Deal calls for production of over 100 million doses of Sputnik V vaccine in China.

  Tim Wright, Editor, Contract Pharma 04.19.21
  

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• Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
  

  Pfizer, BioNTech Expand COVID-19 Vaccine Agreement with EU

  EU orders 100 million additional doses of COMIRNATY, bringing total doses to 600 million for 27 EU member states.

  Tim Wright, Editor, Contract Pharma 04.19.21
  

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• Biologics, Proteins, Vaccines | Breaking News | Industry News
  

  Sartorius Expands in the UK

  New 58,000-square-foot facility aims to simplify and accelerate the production of downstream processing equipment.

  Kristin Brooks 04.16.21
  

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• Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News
  

  Abenza Chooses North Carolina for New Biologics Manufacturing Site

  GMP manufacturing will commence in mid-2022.

  Charles Sternberg, Assistant Editor 04.15.21
  

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• Biologics, Proteins, Vaccines | Breaking News | Industry News | Information Technology
  

  ATMPS, Ori Biotech Integrate Digital Platform for Cell & Gene Therapies

  Aims to provide improved product tracking, scheduling and live monitoring of the manufacturing status across the entire CGT supply chain from vein to vein.

  Kristin Brooks 04.14.21
  

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• Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News
  

  Albumedix Completes Commercial-Scale Mfg. Facility Expansion

  Will service increasing demand for products and technologies for cell and gene therapies, vaccines, diagnostics, protein and peptide therapeutics.

  Kristin Brooks 04.14.21
  

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• Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News
  

  Catalent Biologics Completes Madison Expansion

  More than doubles overall CGMP-scale capacity increasing the number of manufacturing suites at the site to five.

  Kristin Brooks 04.13.21
  

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• Biologics, Proteins, Vaccines | Breaking News | Industry News
  

  Sanofi Invests in Cutting Edge Vax Production Site in Singapore

  The factory will house several fully digitalized modules that allow production of three to four vaccines simultaneously.

  Kristin Brooks 04.12.21
  

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• Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News
  

  Sanofi Acquires Tidal Therapeutics

  Gains novel mRNA-based technology with research capabilities in immuno-oncology and inflammatory diseases, with potential in other disease areas.

  Kristin Brooks 04.12.21
  

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• Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Fill/Finish | Industry News
  

  Moderna, Catalent Enter Long-Term Strategic Vax Pact

  Catalent to dedicate a new high-speed vial filling line for the manufacture of the Moderna COVID-19 Vaccine and potentially other investigational programs.

  Kristin Brooks 04.06.21
  

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• Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News | Parenterals
  

  Sanofi to Build New $700M Flu Vaccine Facility in Canada

  Facility will be located in Toronto and will increase supply of influenza vaccines in Canada, the U.S. and Europe.

  Tim Wright, Editor, Contract Pharma 04.05.21
  

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• Biologics, Proteins, Vaccines | Regulatory Affairs
  

  What Will Change at FDA for 2021?

  (R)evolution of the industry’s data, catalyzed by changes at FDA and what’s the likely impact to the pharmaceutical industry?

  Ben Locwin, Contributing Editor, International COVID-19 Advisor, Healthcare Futurist 04.01.21
  

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• Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News
  

  Eloxx Pharmaceuticals Acquires Zikani Therapeutics

  Combined company brings complementary Ribosomal RNA-targeted genetic therapy platforms together.

  Kristin Brooks 04.01.21
  

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• Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Fill/Finish | Industry News
  

  GSK Supports Manufacture of Novavax’ COVID-19 Vaccine

  GSK will provide fill and finish manufacturing capacity for up to 60 million doses at its Barnard Castle facility.

  Tim Wright, Editor, Contract Pharma 03.31.21
  

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• Cold Chain Management
  

  Cold-Chain Handling Is Not Just a COVID Vaccine Challenge

  More robust solutions for single-use cold-chain containers made with polytetrafluoroethylene fluoropolymers may be less susceptible to failure and breakage.

  Joe Cintavey, Gore PharmBIO 03.30.21
  

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• Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News
  

  Ajinomoto, Bright Peak Enter Immunocytokines Research Pact

  Exclusive license agreement to incorporate Ajinomoto Co.’s AJICAP site-specific bioconjugation technology for the development of Bright Peak Immunocytokines.

  Kristin Brooks 03.30.21
  

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