Phillips-Medisize, a Molex company, has broken ground on a new manufacturing facility in Hudson, Wis., on the eastern end of the Minneapolis-St. Paul metro area. The 34-acre location at the St. Croix Meadows development will support at least 230,000 square feet of manufacturing space for FDA-regulated medical device products, Phillips-Medisize announced yesterday. After construction is complete […]
Contract Services
How Covestro polycarbonate is enabling syringe innovation
Covestro officials are boasting how their Apec 1745 high heat polycarbonate was the material of choice for Gerresheimer AG’s new tamper-evident luer lock closure for syringes. In the growing prefilled syringes market, the adapter for screwing in the needle and the syringe cap plays a key role when it comes to ensuring ease of use and reliable dosage, […]
How suppliers are taking drug-delivery tech to the next level
Medical device industry suppliers and outsourcers are helping to enable the latest drug-delivery tech. Drug-eluting technologies are moving beyond stents, thanks in part to the development of polymeric hydrogels engineered to respond to a range of different physical and chemical stimuli. Medtech innovators have figured out how to use hydrogels as components of micro-shells or […]
PCI Pharma Services to buy Sherpa Clinical Packaging
PCI Pharma Services has agreed to acquire clinical supply services provider Sherpa Clinical Packaging, the companies announced today. Financial terms of the deal were not disclosed. San Diego–based Sherpa is a provider of clinical trial material management services for clinical studies phases I through IV, with expertise in packaging, labeling, distribution, storage and returns and […]
Wacker wins FDA nod to manufacture active ingredient in Chiesi’s thrombolysis drug
Wacker Biotech said today that it won FDA approval to start producing reteplase, the active ingredient in Chiesi‘s thrombolysis drug, Retavase. The medication, which is designed to treat acute myocardial infarction in adults, will be marketed in the U.S. by Chiesi and made in Wacker’s Germany-based plant. Wacker reported that it landed approval to commercially […]
Catalent dishes out $950m for biologics manufacturer
Catalent said today that it plans to purchase Cook Pharmica for $950 million in cash. Cook Pharmica, a unit of privately-held medical device maker Cook Group, is a contract manufacturer that develops biologics-based drug compounds. The deal readies Catalent for an expansion of its biologics biz. Catalent will have access to Cook Pharmica’s Indiana-based facility […]
LabCorp completes $1.2B Chiltern buy
Diagnostics company LabCorp (NYSE:LH) said today that it has closed its $1.2 billion acquisition of contract research organization Chiltern International. Chiltern is slated to fold into the company’s Covance drug development business, which conducts clinical trials for drugmakers. “The addition of Chiltern advances a key element of LabCorp’s strategy – to bring innovative medicines to patients […]
Contract manufacturer Althea launches sterile vial filling line
Contract development & manufacturing organization Althea, an Ajinomoto company, announced today the launch of a new, high-performance sterile vial filling line. The Optima VFVM 7000 aseptic fill finish line adds to Althea’s drug product manufacturing capabilities and enables the company to work with larger batch sizes and a broader range of filling volumes – up […]
Manufacturing drug device products: challenges and best practices
Integrating a drug with a mechanical device can, in some cases, improve patient outcomes and boost sales. But manufacturing these products is no simple feat: It often requires a specialized contract manufacturer with extensive experience in the field to make a drug-device combo buildable and scalable. There’s a lot to consider when manufacturing a medical […]
Aerie’s contract manufacturer faces regulatory hurdle
Aerie Pharmaceuticals (NSDQ:AERI) said today that its contract manufacturer received a complete response letter from the FDA regarding a regulatory application for one of the manufacturer’s own product candidates. The rejection letter reportedly cites a CGMP inspection at the facility as reasoning for the CRL. The facility also manufactures Aerie’s Rhopressa ophthalmic solution, which the FDA […]
