Sionna Licenses Abbvie Assets to Advance Cystic Fibrosis Treatments
网页2024年7月30日 · Sionna Therapeutics, a clinical-stage life sciences company developing differentiated treatments for cystic fibrosis (CF), has obtained exclusive worldwide rights to develop and commercialize multiple clinical-stage compounds through a license agreement with AbbVie.. Under the agreement, Sionna will assume all development responsibilities …
About Us - Contract Pharma
网页Contract Pharma is the premier media outlet linking contract service providers and their pharma/biopharma sponsors. Rooted in our legacy print publication—issued 9 times per year—the Contract Pharma brand continues to evolve across its digital media platforms through ContractPharma.com and social media channels.
BioMarin Names New R&D and Business Development Leaders
网页2024年8月21日 · Welcomes Dr. Greg Friberg as EVP, Chief Research & Development Officer, and Dr. James Sabry as EVP, Chief Business Officer. 08.21.24. BioMarin Pharmaceutical Inc. has made two new leadership appointments: Greg Friberg, M.D., as Executive Vice President, Chief Research & Development Officer, succeeding Hank …
Analytical Method Transfer Best Practices - Contract Pharma
网页2017年11月7日 · Analytical method transfers (AMTs) are typically performed as a precursor to a critical step in the drug-development timeline, such as bringing on a new manufacturing facility, release testing of clinical or commercial material, or initiating stability studies at a quality-control laboratory. AMTs document that a new internal or external ...
Sofgen Pharmaceuticals - Contract Pharma
网页Sofgen Pharmaceuticals, part of Procaps Group, is an integrated Softgel CDMO that offers end-to-end solutions in Softgel technologies from development throughout delivery for generics, prescription drugs, OTC products and specialized nutraceuticals for companies interested in developing and launching novel products in North America, Canada and …
CBE 30 - Contract Pharma
网页2013年3月25日 · Similar to Changes Being Effected (CBE). A filing with the FDA to gain approval of a moderate change, i.e., a change that has a moderate potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product as these factors may relate to the safety or effectiveness of the drug product.
Pharma 4.0 and the Modernizing Power of Digital Technology …
网页2022年6月7日 · Pharma 4.0 is a maturity model-based framework for adapting digital strategies to the unique contexts of pharmaceutical manufacturing—including practical guidance together with quality and regulatory best practices to accelerate transformation and leverage the full potential of digitalization to speed innovation on behalf of patients.
Liquid Fill Hard Capsule Technology - Contract Pharma
网页2016年3月9日 · A simple manufacturing process The LFHC technology process is relatively simple in concept: a typically non-aqueous liquid is filled into the body of the capsule using precision pumps that can deliver a fill weight of 100mg to 1.5 grams as required. The caps are then placed onto the bodies of the capsules.
Corden Pharma - Contract Pharma
网页Serialization. Shipping. Stability Studies. Stability, ICH. Sterile Filling. Supplier, Primary Packaging Materials. Tablet Presses. CordenPharma is your full-service partner in the Contract Development & Manufacturing (CDMO) of APIs, Drug Products and associated Packaging Services.
In-process Control (IPC) - Contract Pharma
网页2013年3月19日 · Checks performed during production to monitor and, if appropriate, to adjust the process to ensure that the intermediate or API (drug substance) conforms to its specifications and/or other defined quality criteria.