Articles

1. API In Capsule Vs. The Lost Art Of Formulation Development 5/5/2020

   Very few businesses have as specialized a set of needs as those in the pharmaceutical sector. The combination of huge product development costs, large amounts of data and intense regulatory control makes it critical for companies to have needed information as soon as possible in order to meet a varied and closely monitored set of business processes. By Todd Daviau, Ph.D

2. Pfizer Issues A Challenge – Cook Pharmica Delivers 9/24/2014

   When Pfizer approached Cook Pharmica about producing a monoclonal antibody, Cook saw it as an opportunity to demonstrate its ability to deliver a product to the specifications the sponsor desired. Cook was fairly new at the time, and had been working with clients for just over four years. The company looked good on paper, and was one of a few facilities that could produce ingredients as well as final drug products in the same facility. Still, Cook executives knew they needed to prove they could measure up to the five driving principles (quality, cost, adaptability, timeliness, and risk) that were crucial to Pfizer.

3. Development and Manufacturing Equipment List 1/13/2014

   Norwich is a leader in solid dose pharmaceutical production. We offer expertise, comprehensive manufacturing and packaging support from clinical trial through scale-up and to commercial launch.

4. Implementing A Single-use TFF System In A cGMP Biomanufacturing Facility 11/26/2013

   This case study describes the process used to transition from a multi‐use system to a single‐use tangential flow filtration (TFF) for performing final buffer exchange steps.

5. The Environmental Impact of Clinical Trials 8/8/2013

   For many years it has been almost universally accepted that there are various sources that may impact or cause disease among which biological, social, and environmental differences have all been investigated. Many clinical trials have been conducted to assess the impact of the environment on outcomes e.g., the effect of the environment on the outcome of studies assessing the efficacy of drugs for patients with dry-eye syndrome, the impact of diet on obesity and cardiovascular disease, and the impact of the environment on autoimmune diseases have all been studied, as have many other interactions.

6. Accelerating Lipid-Based Drug Formulation 7/23/2013

   Formulation scientistsmust develop and validat robust systems that address the challenges posed by increasingly complex drug candidates, in ever shortening time frames.

7. Company Confronts, Conquers Capacity Crisis 4/15/2013

   Upon acquiring several successful product lines from an established global company, a young U.S.generic and branded pharmaceutical manufacturer inherits more than 30 chargeback accounts, introducing a challenge well beyond its processing capacity.By DDN

8. Generic Pharma Start-Up Competitive On Day One 4/1/2013

   The subsidiary of a global pharmaceutical company entering hyper-competitive U.S. generic pharmaceuticals market but lacking efficient supply chain infrastructure to operate profitably. By DDN

9. Brochure: Norwich Clinical Services 2/1/2013

   Norwich Clinical Services is a contract research organization that provides Bioanalytical Services, Pharmacovigilance and Clinical Research Programs to the pharmaceutical and biotech industries.

10. MTOSoftgels - Providing Cohort Specific Hand Filled Softgel Capsules For Dose Escalation Studies 11/1/2012

    When a client needed to manufacture softgel capsule clinical supplies in a low cost, highly dose flexible manner, they turned to Velesco Pharmaceutical Services for MTOSoftgels.