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Samsung Demonstrates Full-Scale ATF Perfusion at Songdo Facility
Using Alternating Tangential Flow in a 3000-L perfusion bioreactor, the company expects to reduce production time by up to 30%
BioLife Solutions Completes Acquisition of SAVSU Technologies
The acquisition strengthens BioLife’s position as a supplier of disruptive, enabling solutions used for manufacturing, storage, and distribution of cell and gene therapies.
HALIX Completes New cGMP Manufacturing Facility; Startup Slated for Q4 2019
The new facility will manufacture biopharmaceutical products under cGMP conditions.
Eurofins Genomics Acquires Blue Heron Biotech, Expands Gene Synthesis Capabilities
The acquisition expands Eurofins Genomics’ gene portfolio while bolstering Blue Heron’s production capabilities.
Topical Products Recalled
Ridge Properties LLC DBA Pain Relief Naturally is voluntarily recalling four lots of 4% lidocaine topical cream and liquid gel products due to microbiological contamination and incorrect potency.
GSK US Pharma Head Steps Down
Jack Bailey, president, US Pharmaceuticals, GlaxoSmithKline, will step down from his position at the end of 2019 and will be succeeded by a Merck KGaA executive.
Keystone Biologicals Acquired by BioIVT for Portfolio Expansion
The acquisition will expand BioIVT’s disease-state portfolio by volume and product range.
Avomeen Analytical Services Introduces New Project Director Role
The new position will expand the company’s large-molecule and protein therapeutics services by partnering with biopharmaceutical clients who are navigating the large-molecule product development life cycle.
Protein Analyzer Offers Ability to Measure Protein Titer Directly from Bioreactor
The Tridex Protein Analyzer from IDEX offers the ability to directly measure protein titer from a bioreactor in real time.
Bayer Acquires BlueRock Therapeutics, Boosts Cell Therapy Stake
The acquisition will boost Bayer’s cell-therapy development programs, with an initial focus on neurology, cardiology, and immunology.
PTC Therapeutics Acquires Biologics Facility from Bristol-Myers Squibb
The facility will support gene therapy production and continued development of PTC’s pipeline of investigational medicines.
South Korea’s Biotech Industry Projected to $23.2 Billion by 2022, According to Industry Report
South Korea’s pharma/biotech space is projected to grow to $23.2 billion by 2022, and will likely attract foreign investment, according to a new market report by GlobalData.
Sartorius Stedim Biotech Launches New Mammalian Cell Bank Services
The company has launched new services for mammalian cell bank manufacturing under GMP conditions.
FDA Publishes Guidance on Rare Pediatric Disease Priority Review
The guidance answers questions about how the agency awards priority review vouchers to sponsors of treatments for rare pediatric diseases.
FDA Gives Guidance on Developing Treatments for Fabry Disease
The guidance discusses clinical trial design features that can support approval of treatments of Fabry disease.
Cambrex to be Acquired by Permira Funds
An affiliate of the Permira funds has signed an agreement to purchase Cambrex in an approximately $2.4-billion transaction.
FDA Issues Statement on Compounding Decision
A US District Court in Washington, DC upheld FDA’s interpretation of clinical need when choosing which substances are approved to use for drug compounding.
FDA Assessing Data Accuracy in Zolgensma Approval
The agency is keeping Zolgensma on the market as it evaluates the accuracy of data submitted with the product’s biologics license application.
Colorcon, TruTag Team Up On-Dose Authentication
Under an agreement, Colorcon will incorporate TruTag’s edible microtag technology in its coatings.
Realizing the Potential of Vaccines
As vaccines gain prominence within pharma, there is an expectation that specialized CDMO services will provide opportunities.
Celebrating in Style
Pharmaceutical Technology Europe celebrates 30 years in publishing the latest insights, analysis, and developments of the bio/pharma industry.
The CDMO Evolution
The evolution of CDMOs has led to increased investment in new technologies, capabilities, and expertise.
Niche APIs By Popular Demand
Rapid change towards industry developing and manufacturing niche APIs is leading to smaller-scale facilities that offer higher containment and flexibility.
Partnering Up for Success
To help customers succeed, CDMOs have moved away from the ‘fee-for-service’ model to offer flexible, full-service partnerships.
In Safe Hands
Complex and potent molecules demand greater technical and regulatory expertise to ensure safe handling.
Regulatory Harmony
Harmonization of regulatory guidelines not only reduces workloads for manufacturers and regulators but can potentially help to accelerate patient access to vital therapies.
Tooling Up for Pharma
Instrumentation advancements over the past 30 years have certainly enabled greater efficiency in pharma development and analysis despite slow adoption by the industry.
Raise a Glass to Pharma Vials
Glass vials have come a long way from mere commodities and are now considered an integral part of final drug product.
Analysis and Purification: Instrumental to BioPharma
To deal with the complex requirements of biopharmaceuticals, companies need a sophisticated toolbox of analytical and purification techniques.
One Small Step for Man, One Giant Leap for Pharma Regulators
European Union regulators have taken a significant step towards resolving some of the major supply-chain difficulties behind medicine shortages.
