Process Validation

APIs | Clinical Trial Materials | Process Validation | QA/QC | Regulatory Affairs

Regis Custom Pharma

07.31.20

Biologics, Proteins, Vaccines | Process Validation

Process Validation in Biologics Development

Strategies for successful process validation in the wake of faster approval timelines.

Victor Vinci and Claudia Berdugo-Davis, Catalent Biologics 05.07.19

3P Enters Mfg. Tie-up With Dutch Biotech Xenikos

3P responsible for process transfer and scale-up, cGMP production for clinical trials and process validation

03.12.19

Support Services - our commitment to quality Jubilant HollisterStier provides a full-range of support and services to streamline the manufacturing process. We offer on-site assistance from process qualifications through product release.…

Contract Pharma Team

.staffInfo {width:550px;float:left;} @media screen and (max-width: 600px){ .staffInfo {float:none;} } .staffPhoto {width:120px;float:left; padding-top:5px; padding-bottom:5px;} Contract Pharma Team President, Rodman J. Zilenziger, Jr.…

02.28.19

Grand River Breaks Ground on Major Expansion

With the support of The Right Place & the MEDC, the 60,000 sq ft facility is expected to be operational by 2020

Videos

Thermo Fisher, Symphogen Enter Collaboration

To deliver validated, platform workflows for simplified characterization & quality monitoring of complex therapeutic proteins

10.29.18

Logistics | Process Validation | QA/QC

Nulogy Launches Quality & Compliance Solution

Capabilities provided to contract packagers are purpose-designed for compliance and GMP compatible and unique to the market

Online Exclusives Betsy Louda, Associate Editor 10.04.18

WuXi STA Enables Ascletis to Receive NDA Approval from China FDA for Ganovo

Is first CDMO to support the approval of an innovative drug in China through the MAH pilot program

06.14.18

Facilities | Fill/Finish | Process Development | Process Validation

Hovione Strengthens Inhalation Services Portfolio

With its new MG2 Tekna Precision Capsule filling unit

01.24.18

Bioanalytical Services | Collaborations & Alliances | Industry News | Methods Development | Process Validation

vTv Therapeutics, Reneo Pharmaceuticals Enter Agreement

The licensing agreement focuses on the PPAR-delta program

12.28.17

Aseptic Processing | Breaking News | Facilities | Industry News | Process Validation

Sterigenics Expands Capacity

$17.5 million investment in Fort Worth site makes it the largest sterilization facility in the company’s network

08.02.17

Process Validation | Regulatory Affairs

Process Validation in the Light of Annex 15 and FDA Requirements

12.09.16

Ajinomoto Bio-Pharma Services

Ajinomoto Bio-Pharma Services is a fully integrated CDMO providing comprehensive process development services, cGMP manufacturing and drug product fill finish services of small molecule and biologic APIs and intermediates.

Kristi Gines, Marketing Strategist 11.07.16

Capsules | Excipients | Process Validation | Validation