Outsourcing

Facility and equipment design are important, but the team and its experience matter most.

Cellular and gene therapy fields are currently on track for, if not already experiencing, a serious capacity crunch.

The radiopharmaceutical CDMO is building a new cGMP facility in Springfield, NJ.

CMDO Piramal Pharma Solutions held a grand opening at a facility they acquired in Sellersville, PA.

The investment at its Madison, WI, facility will expand MilliporeSigma’s capacity for high-potent active pharmaceutical ingredient production and allow for continuous flow manufacturing of ADCs.

The company is investing $130 million to add Phase III through commercial-scale manufacturing suites to its gene therapy campus in Harmans, MD.

Thermo Fisher Scientific is increasing access to cry-electron microscopy with the help of contract research organizations.

Catalent will manufacture drug substance for AZD1222 at its Harmans, MD facility.

CDMO Avid Bioservices will provide development and drug substance manufacturing for Oragenics’ novel COVID-19 vaccine candidate, Terra CoV-2.

Experts at Hovione describe progress being made in understanding how to optimize continuous processes for oral solid-dosage drug products.

The company has made several moves in recent weeks to expand manufacturing capacity and cell line services.

The investment will allow for the expansion of analytical R&D efforts and will support the company’s reference materials business.

The company has launched a residual GMP-compliant test and dual sourcing opportunity designed to increase compliance and reduce risks for ATMP manufacture.

Particle engineering is a useful tool to manipulate API particles into a form that is manufacturable and deliverable to the patient.

COVID-19 has brought to light the issues of European manufacturing capabilities, leading industry to question whether it is now time to reinvest in domestic medicines supply.

Conversations with CMOs/CDMOs about capabilities and how they work to reduce complexities in the supply chain should focus on cost efficiency, temperature excursions, and sustainability.

The right outsourcing partner should open up access to expertise and technical capabilities in a broad range of dosage forms to ensure commercial success.

The early success seen on the market for approved cell and gene therapies poses both technical and manufacturing challenges for pipeline candidates on the road to commercialization.

Contract service providers offer vital services to bio/pharma companies of all sizes. Establishing an effective working relationship and managing operations are key to avoiding compliance issues.

Outsourcing partners provide capacity and tech transfer expertise in the pharmaceutical industry response to the COVID-19 pandemic.

PCI Pharma has announced the creation of a new clinical center of excellence in Western Europe at its site in Berlin, Germany.

Sterling Pharma Solutions has signed a deal with Moleculin Biotech to support the development of WP1122, a potential COVID-19 treatment.

Catalent has unveiled plans to invest in a European center of excellence for clinical biologics formulation development and drug product fill/finish services at its facility in Limoges, France.

Pharmaceutical Technology spoke with Geoff Parker, co-founder of Scimcon about the impact COVID-19 is having on their business.

The acquisition will give the CDMO additional clinical filling options in Europe, which is expected to come online in 2021.