CDMO Avid Bioservices has appointed Elie Hanania as vice president, process development, viral vector technologies to lead the company’s efforts in the CGT space. Sit back, relax, and enjoy this week’s Ins and outs. Biologics contract development and manufacturing organization (CDMO) Avid Bioservices turned to the production of viral vectors in October with plans to build a 53,000 square foot viral vector development and GMP manufacturing facility in Costa Mesa, California at a cost of around $75 million. Now, with…
Upstream & Downstream Processing
Lose the LIMS? Bristol Myers says QC labs of the future need to be digital
Drug quality control labs of the future will need to be more closely integrated with manufacturing operations and make greater use of data management tech and automation, says an industry expert. Quality control is a vital part of ensuring drugs are safe, effective and can be produced consistently. However, despite understanding this importance, manufacturers have often focused on improving manufacturing processes rather than QC labs according to Steve Muller from Bristol Myers Squibb (BMS), who says firm’s looking to digitize…
Aceto buffers up presence in bioprocessing with A&C buy
A&C Bio Buffer is the sixth acquisition for Aceto in the past two years and signals the firm’s ambitions in the biomanufacturing services space. The deal, financials of which have not been disclosed, brings Aceto a GMP (Good Manufacturing Practices) manufacturer of custom buffer and chemical blend products used in the manufacturing of biopharmaceutical drug products, with a facility in Limerick, Ireland producing over 50 products including biological buffers, process solutions, cleaning solutions and WFI (Water for Injection). “A&C Bio…
Simulated Bed fellows: Tosoh buys purification firm Semba
Tosoh Bioscience says it will complement its resins business through the addition of continuous chromatography firm Semba Biosciences. The deal, which closed earlier this month, saw Pennsylvania-based Tosoh add all Semba’s staff and assets for an undisclosed fee. The acquisition will boost the firm’s downstream bioproduction portfolio, made up of chromatography resins, with the addition of Semba’s simulated moving bed (SMB) chromatography systems (see text box below). “Coupled with Semba’s revolutionary multi-column chromatography technology we have found a perfect complement…
MilliporeSigma says viscosity tech overcomes manufacturing challenges
MilliporeSigma has launched a Viscosity Reduction Excipient Platform, which it says helps tackle production and formulation issues associated with highly concentrated protein solutions. According to Merck’s Life Science business MilliporeSigma, the Viscosity Reduction Platform can address specific needs of different protein-based therapeutics through the combination of amino acids and anionic components. “MilliporeSigma’s new Viscosity Reduction Excipient Platform reduces interactions between proteins (including antibodies) that make the product too thick to pass through an injection needle,†Matthias Bucerius, head of actives and formulation at MilliporeSigma told us. “The platform does…
Gamma invests in bio-sensor and analytics firm Nirrin
Nirrin’s near-infrared spectrometry platform offers a reliable and cost-effective method of real-time analytics and will be leveraged across Gamma’s growing bioprocessing network, the firms says. Gamma Biosciences’s undisclosed investment in Maryland-based Nirrin Technologies brings access to sensors and analytics that support the bioprocess space, including automation tech with real-time, in-process monitoring for upstream and downstream applications. “This is a structured investment with longer term features that allow Nirrin to leverage Gamma’s resources and network in the near term as the…
ABEC launches TFF system it says can triple productivity
ABEC claims its Tangential Flow Filtration (TFF) system offers the largest flow rates and filter areas in the industry in a single-use format. ABEC’s Custom Single Run (CSR) Tangential Flow Filtration (TFF) systems were announced this week as an effort to increase downstream productivity for its bioprocess customers. According to the firm, the CSR TFF achieves flow rates greater than 240 liters per minute across cassette-type filter areas up to 40m2, effectively matching levels seen in stainless steel systems, tripling…
Protein boost for Repligen through $150m Avitide buy
The latest acquisition by Repligen will boost its proteins business, adding bespoke affinity purification ligand manufacturer Avitide. The deal sees bioprocess vendor Repligen Corporation shell out $75 million in cash and $75 million in stock for Lebanon, New Hampshire-headquartered firm Avitide. Avitide is a manufacturer of chromatography resins used in downstream bioproduction and its bespoke commercial offering will bolster Repligen’s own proteins business and its affinity ligand discovery service. Repligen’s legacy proteins business – which includes its Protein A chromatography…
Cytiva makes good on China single-use expansion
Plans to triple single-use component production in China through a longstanding partnership with Wego Pharmaceutical are well underway, says Cytiva. Wego Pharmaceutical Co.’s Weihai, China facility makes single-use bioprocessing consumables on behalf of Cytiva after the two firms forged a partnership in November 2018. The site will expand its capacity through plans envisaged last September but announced last week. “Three new manufacturing lines were launched in under ten months with an additional eight new lines planned to launch in Q3…
Advantages of flexible manufacturing in advanced therapies
With rapid market growth and over 1220 ongoing clinical trials, the need for flexible alternatives is higher than ever. To meet this demand, advanced therapeutic developers are utilizing flexible manufacturing and single-use technologies. This is an abridged version of an article first published as part of the BioProcess Insider ebook, entitled: Cell and Gene Therapies — A 2021 Industry Update. To download the full report, click here. Utilizing flexible systems like premanufactured cleanrooms can reduce costs, construction timelines, and time…