Coriolis Pharma is a science-driven and globally operating contract research and development organization. We support drug product development of biopharmaceuticals, including ATMPs and vaccines, from early development to commercialization. Our focus lies on formulation development, lyophilization technologies and analytics (GMP and non-GMP).
The importance of reagent quality control, especially endotoxin testing, during CGT development and the selection of reagents and suppliers to ensure safety.
Garrett Perry, Technical Services Specialists at Teknova09.14.21
Spray drying is an established particle engineering technology that offers several advantages over other methods used for improving API bioavailability.
Bikash Chatterjee of Pharmatech Associates discusses the reshoring trend, technologies and advances that could help deliver more manufacturing back to the U.S.
Market estimated to grow at CAGR of 20% from 2021 to 2028 due to an exponential rise in clinical pipeline along with rising number of regulatory approvals.
Will leverage integrated services from Selexis and KBI as part of Immatics’ development of TCR Bispecifics, designed to detect, target and attack tumor cells.
LION-101 is a recombinant adeno-associated virus based vector being developed as a one-time intravenous infusion for Limb-Girdle Muscular Dystrophy Type 2I/R9.
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.
Will integrate Cryoport's Cryoportal Logistics Management Platform and LabConnect's SampleGISTICS platform to provide Triumvira with advanced logistics support.
Collaboration investigates enhanced manufacturing of AAV and lentiviral vectors to improve quality and productivity for gene therapy and vaccine developers.
Aims to provide improved product tracking, scheduling and live monitoring of the manufacturing status across the entire CGT supply chain from vein to vein.
Dendritic cell vaccine production capacity for personalized immune therapies increases from about 4 - 6 patients per month to about 40 - 45 patients per month.
Adds Project Farma's unique expertise to Precision's suite of end-to-end cell and gene therapy capabilities to support development and commercialization.
Will accelerate the commercialization of Koligo’s KYSLECEL, a personalized islet cell therapy available in the U.S. for chronic and recurrent acute pancreatitis
Newark, NJ process development and clinical manufacturing facility for cell and gene therapies becomes first of its kind located on a U.S. university campus.
A fully functional 20,000 sq. ft. GMP facility featuring 10 ISO Class 7/Grade B clean rooms to enable production of cells and viral vectors for Phase I and II clinical trials.
CDMO’s capacity to produce AAV materials at large-scale will support Genethon and Sarepta’s project to take micro-dystrophin to clinical trials this year.
Mike Grippo will serve as senior vice president, Strategy and Corporate Development, and Julien Meissonnier as vice president and chief scientific officer
As companies move their cell and gene therapies through the development process, supporting larger Phase III trials and commercial launches will be a challenge
Ryan Carpentier, Executive Director of Business Development, Cryoport09.23.19
Cytegrity™ is a stable producer cell line developed by St. Jude Children’s Research Hospital for the treatment of X-linked severe combined immunodeficiency
Andrew Kolbert of Avomeen discusses FDA oversight of E&L testing, complications that arise, and the expertise needed to keep up with changing quality standards
Paragon Gene Therapy, part of Catalent Biologics, will provide materials for preclinical and Phase 1/2 trials for IVERIC’s gene therapy product candidates
Voyager gains worldwide rights to VY-HTT01 Huntington’s disease program and ex-U.S. rights to VY-FXN01 Friedreich’s ataxia program for $10 million upfront
John Mosack head GMP mfg. at Baltimore site; Adam Sachs to lead program mgmt. and client alliance; Deborah Wild is chief quality and reg. affairs officer
To provide funding for the development of a training program to enable incumbent employees in the biopharma industry to acquire competencies in the field
Designed for more efficient buffer delivery and is tailored to provide the highest level of accuracy and precision in buffer preparation and management
New drug product manufacturing facility in Waigaoqiao Free Trade Zone of Shanghai has passed its first GMP inspection by the European Medical Products Agency
Scott J. Fisher, PhD has previously led drug development and gene therapy clinical research of multiple regenerative therapies at early stage companies
Gains licenses for manufacture, downstream processing into capsules and tablets, as well as spray dried formulations of biotherapeutics and small molecule APIs
Everyone talks about biosimilarity, but it’s clarifying the differences between biosimilars, biobetters and me-too products that will be critical to biological innovation and pricing
What level of GMP need to be followed for clinical trial materials (for a generic ANDA) intended for animal studies if the drug is already in the market?
Labtec GmbH, a subsidiary of tesa SE, has opened its new GMP manufacturing facility for transdermal drug delivery systems (TDS) and oral dispersible films (ODF) employing its RapidFilm technology.
Dalton Pharma Services has entered into a manufacturing services agreement with Zafgen, Inc. to provide cGMP aseptic fill/finish services and analytical support for Zafgen’s lead obesity treatment.
Thermo Fisher Scientific, Inc. has signed definitive agreements to sell its Lancaster Laboratories and Athena Diagnostics businesses for a total of $940 million in cash.
Alphora will further expand its facilities and capabilities for API technology development across all areas, with a focus on R&D, cGMP operations, and analytical services.
AMT has entered into an agreement with Institut Pasteur, and a group of French research institutes (the "Consortium"), to support clinical development of a gene therapy to treat Sanfilippo B.
Watson Pharmaceuticals’ Eden Biodesign, Ltd., has entered a non-exclusive vendor network agreement with Crucell, under which Eden Biodesign becomes an authorized provider of process development and cGMP manufacturing services using Crucell’s P
ICON has opened a purpose-built clinical pharmacology unit in the Central Manchester University Hospitals Foundation Trust (CMFT) campus in Manchester, UK.
Millipore Corp. has moved its European BioPharma Services unit to new, expanded facilities located in Milton Park, near Didcot in Oxfordshire, England.
Azopharma Drug Development Services has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for production of commercial product.
Laureate Pharma and Iconic Therapeutics, a developer of ophthalmic products, have completed the manufacture of the first GMP lot of hI-con1 recombinant Fc-Factor VII fusion protein for the potential treatment of macular degeneration and other diseases.
Covance, Inc. has added cGMP melamine testing services in North America to meet recent FDA guidance on melamine testing for pharmaceutical and animal health manufacturers.
Norwich Pharmaceuticals, Inc. has formed a strategic alliance with Emerson Resources, Inc. focused on bringing together the capabilities of the two companies in order to provide a broader range of services to the industry.
Novozymes Biopharma's Recombumin and albucult products are the first to comply with the new excipient monograph standard for recombinant human albumin, published in the U.S. Pharmacopoeia - National Formulary (USP-NF). First
Sinovac Biotech Ltd. has received GMP certification from the Chinas State Food and Drug Administration (SFDA) for its filling and packaging production facility.
Covance is expanding its biotechnology services facility in Harrogate, UK. The company also received a cGMP Manufacturing License from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK.